DysmenorrheaPhase 2/3NCT00461305
Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea
A Phase 2/3 study testing DRSP 3 mg/EE 20 µg (13 cycles) and DRSP 3 mg/EE 30 µg (6 cycles) in people with Dysmenorrhea, run by Bayer at 26 sites in Japan.
Trial summary
The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- DRSP 3 mg/EE 20 µg (13 cycles) and DRSP 3 mg/EE 30 µg (6 cycles)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 26 sitesJapan
- Study dates
- Feb 2007to Aug 2009
- Phase
- Phase 2/3
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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 years or older at obtaining informed consent
- Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before the final enrollment
- Patients having a total dysmenorrheal score of at least 3 points in twice of the latest menstruation before the final enrollment
Who cannot join
- Patients with ovarian chocolate cysts
- Patients with fibroid needed to be treated
- Patients with estrogen-dependent tumors and patients with cervical cancer or suspected cervical cancer
- Patients with undiagnosed abnormal vaginal bleeding
- Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, or coronary artery disease or a history of those diseases
- Patients aged 35 years or older who smoke at least 15 cigarettes per day
Show all 11Show fewer
- Patients with migraine accompanied by prodromata
- Patients with pulmonary hypertension or valvular heart disease
- Patients who are regularly taking nutritional products that contain St. John's Wort
- Patients who underwent surgical treatment for endometriosis within 2 months prior to screening
- Patients who may need to regularly use analgesics for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Japan26 sites
Study site
Chuo-ku, Tokyo, 104-0061
Study site
Hachiōji, Tokyo, 192-0046
Study site
Kobe, Hyōgo, 650-0021
Study site
Machida, Tokyo, 194-0022
Study site
Maebashi, Gunma, 371-0024
Study site
Musashino, Tokyo, 180-0003
Study site
Nagoya, Aichi-ken, 460-0007
Study site
Nagoya, Aichi-ken, 460-0011
Study site
Nagoya, Aichi-ken, 464-0066
Study site
Nishinomiya, Hyōgo, 663-8204
Study site
Osaka, Osaka, 530-0013
Study site
Osaka, Osaka, 534-0014
Study site
Ōta-ku, Tokyo, 144-0052
Study site
Sendai, Miyagi, 980-0021
Study site
Sendai, Miyagi, 981-0933
Study site
Sendai, Miyagi, 984-0042
Study site
Setagaya-ku, Tokyo, 156-0042
Study site
Setagaya-ku, Tokyo, 157-0066
Study site
Shibuya-ku, Tokyo, 150-0013
Study site
Shinagawa-ku, Tokyo, 140-0013
Study site
Suginami-ku, Tokyo, 167-0051
Study site
Takasaki, Gunma, 370-0883
Study site
Toshima-ku, Tokyo, 171-0021
Study site
Toyonaka, Osaka, 560-0022
Study site
Yamato, Kanagawa, 242-0007
Study site
Yokohama, Kanagawa, 231-0861
About this study
Official title: A Multicenter, Single-blind, Randomized Study, to Investigate Efficacy of Ethinylestradiol for Intracyclic Bleeding Profile During 24 Weeks (6 Cycles) by Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg and Drospirenone 3 mg/ Ethinylestradiol 30 µg in Patients With Dysmenorrheal and to Investigate the Long Term Safety Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg Administered for 52 Weeks (13 Cycles)
The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety
Read the detailed description
The "drospirenone 3 mg/ethinylestradiol 20 μg (13 cycles)" group is to be treated by oral administration for 52 weeks, 13 cycles. The "drospirenone 3 mg/ethinylestradiol 30 μg (6 cycles)" group is to be treated by oral administration for 24 weeks, 6 cycles.
The trial is sponsored by Bayer Yakuhin, Ltd.
- Conditions
- Dysmenorrhea
- Being tested
- DRSP 3 mg/EE 20 µg (13 cycles), DRSP 3 mg/EE 30 µg (6 cycles)
- Keywords
- Dysmenorrhea, Intracyclic bleeding, Drospirenone (DRSP), Ethinylestradiol
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRSP 3 mg/EE 20 µg (13 cycles)Drug
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
DRSP 3 mg/EE 30 µg (6 cycles)Drug
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
| Study group | Role | What they receive |
|---|---|---|
| DRSP 3 mg/EE 20 µg (13 cycles) | Experimental | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) Receives: Drug: DRSP 3 mg/EE 20 µg (13 cycles) |
| DRSP 3 mg/EE 30 µg (6 cycles) | Experimental | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) Receives: Drug: DRSP 3 mg/EE 30 µg (6 cycles) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Intracyclic Bleeding at Cycle 6
Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
Measured: Up to Cycle 6 (168 days) with 28 days per cycle
Secondary outcomes (34)
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6
Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.
Measured: From baseline up to Cycle 6 (168 days) with 28 days per cycle
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13
Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.
Measured: From baseline up to Cycle 13 (364 days) with 28 days per cycle
Distribution of Total Dysmenorrhea Score at Cycle 6
Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.
Measured: Up to Cycle 6 (168 days) with 28 days per cycle
Distribution of Total Dysmenorrhea Score at Cycle 13
Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.
Measured: Up to Cycle 13 (364 days) with 28 days per cycle
Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6
Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Measured: Up to Cycle 6 (168 days) with 28 days per cycle
Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13
Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Measured: Up to Cycle 13 (364 days) with 28 days per cycle
Distribution of Severity of Lumbago During Menstruation at Cycle 6
Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Measured: Up to Cycle 6 (168 days) with 28 days per cycle
Distribution of Severity of Lumbago During Menstruation at Cycle 13
Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Measured: Up to Cycle 13 (364 days) with 28 days per cycle
Distribution of Severity of Headache During Menstruation at Cycle 6
Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Measured: Up to Cycle 6 (168 days) with 28 days per cycle
Distribution of Severity of Headache During Menstruation at Cycle 13
Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Measured: Up to Cycle 13 (364 days) with 28 days per cycle
Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6
Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Measured: Up to Cycle 6 (168 days) with 28 days per cycle
Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13
Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Measured: Up to Cycle 13 (364 days) with 28 days per cycle
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6
Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.
Measured: Up to Cycle 6 (168 days) with 28 days per cycle
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13
Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.
Measured: Up to Cycle 13 (364 days) with 28 days per cycle
Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6
VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
Measured: From baseline up to Cycle 6 (168 days) with 28 days per cycle
Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13
VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
Measured: From baseline up to Cycle 13 (364 days) with 28 days per cycle
Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6
VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
Measured: From baseline up to Cycle 6 (168 days) with 28 days per cycle
Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13
VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
Measured: From baseline up to Cycle 13 (364 days) with 28 days per cycle
Number of Any Bleeding Episodes From Cycle 1 to Cycle 6
Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days).
Measured: Up to Cycle 6 (168 days) with 28 days per cycle
Number of Any Bleeding Episodes From Cycle 1 to Cycle 13
Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days).
Measured: Up to Cycle 13 (364 days) with 28 days per cycle
Number of Any Bleeding Days From Cycle 1 to Cycle 6
Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days).
Measured: Up to Cycle 6 (168 days) with 28 days per cycle
Number of Any Bleeding Days From Cycle 1 to Cycle 13
Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 4 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days).
Measured: Up to Cycle 13 (364 days) with 28 days per cycle
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6
Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
Measured: Up to Cycle 6 (168 days) with 28 days per cycle
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13
Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
Measured: Up to Cycle 13 (364 days) with 28 days per cycle
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6
Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.
Measured: Up to Cycle 6 (168 days) with 28 days per cycle
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13
Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.
Measured: Up to Cycle 13 (364 days) with 28 days per cycle
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6
Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).
Measured: Up to Cycle 6 (168 days) with 28 days per cycle
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13
Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).
Measured: Up to Cycle 13 (364 days) with 28 days per cycle
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6
Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).
Measured: Up to Cycle 6 (168 days) with 28 days per cycle
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13
Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).
Measured: Up to Cycle 13 (364 days) with 28 days per cycle
Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6
CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.
Measured: From baseline up to Cycle 6 (168 days) with 28 days per cycle
Change in Serum CA-125 From Baseline to Cycle 13
CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.
Measured: From baseline up to Cycle 13 (364 days) with 28 days per cycle
Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6
CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.
Measured: From baseline up to Cycle 6 (168 days) with 28 days per cycle
Change in Serum CRP From Baseline to Cycle 13
CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.
Measured: From baseline up to Cycle 13 (364 days) with 28 days per cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startFeb 2007
- Primary completionJan 2009
- Study completionAug 2009
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 (1)Papers the sponsor has linked to this study.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461305
- Sponsor's protocol ID
- 91616
- Other IDs
- 310284
- Status last verified
- Jan 2013
- First submitted
- 17 Apr 2007
- Last updated
- 24 Jan 2013
- 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 37523477