Primary DysmenorrheaPhase 3NCT00909857
Effect on Primary Dysmenorrhea
A Phase 3 study testing Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) and Ethinyl estradiol, Levonorgestrel (Miranova) in people with Primary Dysmenorrhea, run by Bayer at 41 sites in 6 countries.
Trial summary
To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use. Read more about this study
- Who is it for?
- Ages 14 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) and Ethinyl estradiol, Levonorgestrel (Miranova)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 507 participants
- Where
- 41 sitesin 6 countries
- Study dates
- Apr 2009to Nov 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Otherwise healthy female subjects requesting contraception and suffering from primary dysmenorrhea with a sum score for dysmenorrheic pain intensity of >/= 8 over 2 baseline cycles documented by a prospective self-rated sum pain score
- Age: 14 - 50 years (inclusive; smokers must not be older than 30 years) at the time point of informed consent
- Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at the screening visit, or a normal result has to be available that was documented within the last 6 months before the screening visit)
- Women with cyclic menstrual bleeding, defined by a cycle length between 25 and 35 days and no amenorrheic cycles or cycles without withdrawal bleeding during the last 3 months prior to visit 1.
- Able to tolerate ibuprofen and willing to use only Ibuprofen supplied for the study.
Who cannot join
- Pregnancy or lactation (delivery, abortion, or lactation within three cycles before the start of treatment)
- Obesity: body mass index (BMI) > 32 kg/m2
- Hypersensitivity to any of the study drug ingredients
- Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
- Presence or a history of venous or arterial thrombotic / thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischemic attack, angina pectoris), and conditions that could increase the risk of suffering from any of the above mentioned disorders, e.g. a family history indicating a hereditary predispositionUndiagnosed abnormal genital bleeding
- Abuse of alcohol, drugs, or medicines (e.g. laxatives)
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- Other contraceptive methods:
- Sterilization
- Oral, vaginal or transdermal hormonal contraception during treatment
- Intra-uterine devices (IUD) with or without hormone release still in place within 30 days of visit 1
- Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator
- Major surgery scheduled for the study period
Trial locations and contacts
41 sites in 6 countries.
41 sites in 6 countries
United States10 sites
Study site
Hialeah, Florida, 33012
Study site
Idaho Falls, Idaho, 83404
Study site
La Crosse, Wisconsin, 54691
Study site
Leesburg, Florida, 34748
Study site
Philadelphia, Pennsylvania, 19114
Study site
Pittsburgh, Pennsylvania, 15206
Study site
San Diego, California, 92108
Study site
Sandy Springs, Georgia, 30328
Study site
Tucson, Arizona, 85741
Study site
Winston-Salem, North Carolina, 27103
Italy10 sites
Study site
Bologna, 40138
Study site
Brescia, 25123
Study site
Francavilla Fontana, Brindisi, 72021
Study site
Milan, 20121
Study site
Modena, 41124
Study site
Perugia, 06156
Study site
Roma, 00161
Study site
Siena, 53100
Study site
Torino, 10126
Study site
Udine, 33100
Germany7 sites
Study site
Bernburg, Saxony-Anhalt, 06406
Study site
Cologne, North Rhine-Westphalia, 50931
Study site
Essen, North Rhine-Westphalia, 45127
Study site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Study site
Hamburg, Free and Hanseatic City of Hamburg, 22159
Study site
Leipzig, Saxony, 04207
Study site
Magdeburg, Saxony-Anhalt, 39126
Philippines6 sites
Study site
Cebu
Study site
Cebu City
Study site
Davao City
Study site
Metro Manila, 1000
Study site
Metro Manila
Study site
Quezon City
Canada5 sites
Study site
Langley, British Columbia, V3A 4H9
Study site
Pointe-Claire, Quebec, H9R 4S3
Study site
Regina, Saskatchewan, S4P 3X1
Study site
Ste-Foy, Quebec, G1V 4X7
Study site
Toronto, Ontario, M5C 2T2
About this study
Official title: A Multi-center, Double-blind, Double-dummy, Randomized, Controlled, Parallel-group Study to Assess Efficacy and Safety of SH T00658ID Compared to SH D593B in the Treatment of Primary Dysmenorrhea
To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027), Ethinyl estradiol, Levonorgestrel (Miranova), Placebo Match to SH T00658ID, Placebo Match to SH D593B
- Keywords
- Primary Dysmenorrhea, Oral Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)Drug
Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval
Ethinyl estradiol, Levonorgestrel (Miranova)Drug
Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval
Placebo Match to SH T00658IDDrug
Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
Placebo Match to SH D593BDrug
Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
| Study group | Role | What they receive |
|---|---|---|
| Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Experimental | Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles Receives: Drug: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027); Drug: Placebo Match to SH T00658ID |
| Ethinyl estradiol, Levonorgestrel (Miranova) | Active comparator | Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles Receives: Drug: Ethinyl estradiol, Levonorgestrel (Miranova); Drug: Placebo Match to SH D593B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain
Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
Measured: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Secondary outcomes (67)
Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain
Dysmenorrheic pain: pelvic pain during menstrual/withdrawal bleeding (WB) episode and 2 days before. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: 2 days before 1st menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of 1st treatment cycle until 3rd day before WB of the cycle after 2nd treatment cycle (normalized to standard 56-day period). Score difference min -168 (best), max 168 (worst)
Measured: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding
Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
Measured: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding
Evaluated was the number of days with bleeding-associated pelvic pain, excluding days during withdrawal bleeding (WB) and the 2 days preceding such WB, and during administration deviation bleeding and the 2 days preceding such bleeding (normalized to a standard 56-day period). Baseline period: 2 days before first menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of the 1st treatment cycle until 3rd day before the WB of the cycle after the 2nd treatment cycle (normalized to standard 56-day period).
Measured: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode)
Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
Measured: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)
Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
Measured: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before)
Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
Measured: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used)
Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
Measured: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Percentage of Participants Satisfied With Study Treatment
Participants were asked to express the degree of their satisfaction with study treatment.
Measured: From cycle 1 to cycle 3 (28 days per cycle)
Number of Days With Bleeding or Spotting
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Measured: From day 1 to day 90
Number of Episodes With Bleeding or Spotting
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Measured: From day 1 to day 90
Mean Length of Bleeding or Spotting Episodes
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Measured: From day 1 to day 90
Maximum Length of Bleeding or Spotting Episodes
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Measured: From day 1 to day 90
Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Measured: From day 1 to day 90
Number of Days With Spotting-only
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Measured: From day 1 to day 90
Number of Episodes With Spotting-only
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Measured: From day 1 to day 90
Mean Length of Spotting Only Episodes
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Measured: From day 1 to day 90
Maximum Length of Spotting Only Episodes
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Measured: From day 1 to day 90
Difference in Duration Between Longest and Shortest Spotting Only Episode
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Measured: From day 1 to day 90
Percentage of Participants With Withdrawal Bleeding at Cycle 1
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Measured: At cycle 1 (28 days per cycle)
Percentage of Participants With Withdrawal Bleeding at Cycle 3
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Measured: At cycle 3 (28 days per cycle)
Length of Withdrawal Bleeding Episodes at Cycle 1
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Measured: At cycle 1 (28 days per cycle)
Length of Withdrawal Bleeding Episodes at Cycle 3
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Measured: At cycle 3 (28 days per cycle)
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.
Measured: At cycle 1 (28 days per cycle)
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.
Measured: At cycle 3 (28 days per cycle)
Onset of Withdrawal Bleeding Episodes at Cycle 1
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Measured: At cycle 1 (28 days per cycle)
Onset of Withdrawal Bleeding Episodes at Cycle 3
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Measured: At cycle 3 (28 days per cycle)
Percentage of Participants With Intracyclic Bleeding at Cycle 1
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Measured: At cycle 1 (28 days per cycle)
Percentage of Participants With Intracyclic Bleeding at Cycle 3
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Measured: At cycle 3 (28 days per cycle)
Number of Intracyclic Bleeding Episodes at Cycle 1
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Measured: At cycle 1 (28 days per cycle)
Number of Intracyclic Bleeding Episodes at Cycle 3
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Measured: At cycle 3 (28 days per cycle)
Maximum Length of Intracyclic Bleeding Episodes at Cycle 1
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Measured: At cycle 1 (28 days per cycle)
Maximum Length of Intracyclic Bleeding Episodes at Cycle 3
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Measured: At cycle 3 (28 days per cycle)
Number of Intracyclic Bleeding Days at Cycle 1
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.
Measured: At cycle 1 (28 days per cycle)
Number of Intracyclic Bleeding Days at Cycle 3
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.
Measured: At cycle 3 (28 days per cycle)
Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.
Measured: At cycle 1 (28 days per cycle)
Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.
Measured: At cycle 3 (28 days per cycle)
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening
The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.
Measured: At screening (28 days)
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle
The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.
Measured: At Baseline (28 days per cycle)
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2
The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.
Measured: At cycle 2 (28 days per cycle)
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination
The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.
Measured: At final examination (28 days)
Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
The participants were asked to complete a resource use questionnaire indicating their own costs of physiotherapy per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Measured: At screening (average over 3 months before screening)
Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
The participants were asked to complete a resource use questionnaire indicating their own costs of pain medication per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Measured: At screening (average over 3 months before screening)
Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
The participants were asked to complete a resource use questionnaire indicating their own costs of vitamins per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Measured: At screening (average over 3 months before screening)
Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
The participants were asked to complete a resource use questionnaire indicating their own costs of massages per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Measured: At screening (average over 3 months before screening)
Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
The participants were asked to complete a resource use questionnaire indicating their own costs of acupuncture per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Measured: At screening (average over 3 months before screening)
Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
The participants were asked to complete a resource use questionnaire indicating their own costs of medical counseling per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Measured: At screening (average over 3 months before screening)
Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
The participants were asked to complete a resource use questionnaire indicating their own costs of alternative medicine per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Measured: At screening (average over 3 months before screening)
Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
The participants were asked to complete a resource use questionnaire indicating their own costs of herbs/teas per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Measured: At screening (average over 3 months before screening)
Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
The participants were asked to complete a resource use questionnaire indicating their other own costs per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Measured: At screening (average over 3 months before screening)
Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression
The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women's health in particular. Investigators were asked to rate the participants' improvement during the course of the study.
Measured: At cycle 2 (28 days per cycle)
Participants With Improvement in Participants' Assessment in the Clinical Global Impression
The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women's health in particular. Participants were asked to rate their improvement during the course of the study.
Measured: At cycle 2 (28 days per cycle)
Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Measured: At baseline cycle (28 days per cycle)
Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Measured: at final examination (28 days)
Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Measured: At baseline cycle (28 days per cycle)
Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Measured: At final examination (28 days)
Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Measured: At baseline cycle (28 days per cycle)
Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Measured: At final examination (28 days)
Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Measured: At baseline cycle (28 days per cycle)
Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Measured: At final examination (28 days)
General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Measured: At baseline cycle (28 days per cycle)
General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Measured: At final examination (28 days)
Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Measured: At baseline cycle (28 days per cycle)
Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Measured: At final examination (28 days)
Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Measured: At baseline cycle (28 days per cycle)
Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Measured: At final examination (28 days)
Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Measured: At baseline cycle (28 days per cycle)
Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Measured: At final examination (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909857
- Sponsor's protocol ID
- 91781
- Other IDs
- 2008-005625-11, 312042, 2008
- Status last verified
- Aug 2015
- First submitted
- 24 Apr 2009
- Last updated
- 24 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Schroll JB, Black AY, Farquhar C, Chen I. Combined oral contraceptive pill for primary dysmenorrhoea. Cochrane Database Syst Rev. 2023 Jul 31;7(7):CD002120. doi: 10.1002/14651858.CD002120.pub4.
PubMed 37523477Petraglia F, Parke S, Serrani M, Mellinger U, Romer T. Estradiol valerate plus dienogest versus ethinylestradiol plus levonorgestrel for the treatment of primary dysmenorrhea. Int J Gynaecol Obstet. 2014 Jun;125(3):270-4. doi: 10.1016/j.ijgo.2013.11.017. Epub 2014 Mar 11.
PubMed 24713413
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Double-dummy, Randomized, Controlled, Parallel-group Study to Assess Efficacy and Safety of SH T00658ID Compared to SH D593B in the Treatment of Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT00909857
- Acronym / sponsor ID
- 91781
- Conditions
- Primary Dysmenorrhea
- Keywords
- Primary Dysmenorrhea, Oral Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 507 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 29 May 2009 (estimated)
- Results
- Posted 27 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Experimental | Drug: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027), Drug: Placebo Match to SH T00658IDDaily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles |
| Ethinyl estradiol, Levonorgestrel (Miranova) | Active comparator | Drug: Ethinyl estradiol, Levonorgestrel (Miranova), Drug: Placebo Match to SH D593BDaily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Otherwise healthy female subjects requesting contraception and suffering from primary dysmenorrhea with a sum score for dysmenorrheic pain intensity of >/= 8 over 2 baseline cycles documented by a prospective self-rated sum pain score
- Age: 14 - 50 years (inclusive; smokers must not be older than 30 years) at the time point of informed consent
- Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at the screening visit, or a normal result has to be available that was documented within the last 6 months before the screening visit)
- Women with cyclic menstrual bleeding, defined by a cycle length between 25 and 35 days and no amenorrheic cycles or cycles without withdrawal bleeding during the last 3 months prior to visit 1.
- Able to tolerate ibuprofen and willing to use only Ibuprofen supplied for the study.
Key exclusion criteria (12 listed)
- Pregnancy or lactation (delivery, abortion, or lactation within three cycles before the start of treatment)
- Obesity: body mass index (BMI) > 32 kg/m2
- Hypersensitivity to any of the study drug ingredients
- Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
- Presence or a history of venous or arterial thrombotic / thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischemic attack, angina pectoris), and conditions that could increase the risk of suffering from any of the above mentioned disorders, e.g. a family history indicating a hereditary predispositionUndiagnosed abnormal genital bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval | Drug | Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) |
| Ethinyl estradiol, Levonorgestrel (Miranova)Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval | Drug | Ethinyl estradiol, Levonorgestrel (Miranova) |
| Placebo Match to SH T00658IDDaily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles. | Drug | Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) |
| Placebo Match to SH D593BDaily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles. | Drug | Ethinyl estradiol, Levonorgestrel (Miranova) |
Primary outcome
Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain
Time frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
67 secondary outcomes
Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain
Time frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding
Time frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding
Time frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode)
Time frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)
Time frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before)
Time frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used)
Time frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Percentage of Participants Satisfied With Study Treatment
Time frame: From cycle 1 to cycle 3 (28 days per cycle)
Number of Days With Bleeding or Spotting
Time frame: From day 1 to day 90
Number of Episodes With Bleeding or Spotting
Time frame: From day 1 to day 90
Mean Length of Bleeding or Spotting Episodes
Time frame: From day 1 to day 90
Maximum Length of Bleeding or Spotting Episodes
Time frame: From day 1 to day 90
Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode
Time frame: From day 1 to day 90
Number of Days With Spotting-only
Time frame: From day 1 to day 90
Number of Episodes With Spotting-only
Time frame: From day 1 to day 90
Mean Length of Spotting Only Episodes
Time frame: From day 1 to day 90
Maximum Length of Spotting Only Episodes
Time frame: From day 1 to day 90
Difference in Duration Between Longest and Shortest Spotting Only Episode
Time frame: From day 1 to day 90
Percentage of Participants With Withdrawal Bleeding at Cycle 1
Time frame: At cycle 1 (28 days per cycle)
Percentage of Participants With Withdrawal Bleeding at Cycle 3
Time frame: At cycle 3 (28 days per cycle)
Length of Withdrawal Bleeding Episodes at Cycle 1
Time frame: At cycle 1 (28 days per cycle)
Length of Withdrawal Bleeding Episodes at Cycle 3
Time frame: At cycle 3 (28 days per cycle)
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
Time frame: At cycle 1 (28 days per cycle)
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
Time frame: At cycle 3 (28 days per cycle)
Onset of Withdrawal Bleeding Episodes at Cycle 1
Time frame: At cycle 1 (28 days per cycle)
Onset of Withdrawal Bleeding Episodes at Cycle 3
Time frame: At cycle 3 (28 days per cycle)
Percentage of Participants With Intracyclic Bleeding at Cycle 1
Time frame: At cycle 1 (28 days per cycle)
Percentage of Participants With Intracyclic Bleeding at Cycle 3
Time frame: At cycle 3 (28 days per cycle)
Number of Intracyclic Bleeding Episodes at Cycle 1
Time frame: At cycle 1 (28 days per cycle)
Number of Intracyclic Bleeding Episodes at Cycle 3
Time frame: At cycle 3 (28 days per cycle)
Maximum Length of Intracyclic Bleeding Episodes at Cycle 1
Time frame: At cycle 1 (28 days per cycle)
Maximum Length of Intracyclic Bleeding Episodes at Cycle 3
Time frame: At cycle 3 (28 days per cycle)
Number of Intracyclic Bleeding Days at Cycle 1
Time frame: At cycle 1 (28 days per cycle)
Number of Intracyclic Bleeding Days at Cycle 3
Time frame: At cycle 3 (28 days per cycle)
Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
Time frame: At cycle 1 (28 days per cycle)
Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
Time frame: At cycle 3 (28 days per cycle)
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening
Time frame: At screening (28 days)
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle
Time frame: At Baseline (28 days per cycle)
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2
Time frame: At cycle 2 (28 days per cycle)
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination
Time frame: At final examination (28 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37523477Schroll JB, Black AY, Farquhar C, Chen I. Combined oral contraceptive pill for primary dysmenorrhoea. Cochrane Database Syst Rev. 2023 Jul 31;7(7):CD002120. doi: 10.1002/14651858.CD002120.pub4.
- Derived from this study: PubMed 24713413Petraglia F, Parke S, Serrani M, Mellinger U, Romer T. Estradiol valerate plus dienogest versus ethinylestradiol plus levonorgestrel for the treatment of primary dysmenorrhea. Int J Gynaecol Obstet. 2014 Jun;125(3):270-4. doi: 10.1016/j.ijgo.2013.11.017. Epub 2014 Mar 11.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
41 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) and Ethinyl estradiol, Levonorgestrel (Miranova) in people with Primary Dysmenorrhea, run by Bayer at 41 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Italy, Germany, Philippines, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain (time frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00909857, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2015.