Primary DysmenorrheaPhase 3NCT00569244
SH T00186 in the Treatment of Primary Dysmenorrhea
A Phase 3 study testing Drug: YAZ flex (SH T00186D) and YAZ (SH T00186D) in people with Primary Dysmenorrhea, run by Bayer at 27 sites in 2 countries.
Trial summary
The investigational drug SH T00186D is an oral contraceptive. The investigational drug used in this study contains the estrogen ethinylestradiol (EE) and the progestogen drospirenone (DRSP). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Drug: YAZ flex (SH T00186D) and YAZ (SH T00186D)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 27 sitesin 2 countries
- Study dates
- Dec 2007to Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Otherwise healthy female patients with moderate to severe primary dysmenorrhea
- Prospective self-rated sum pain score of >/= 8 during the 2 baseline cycles
- Age between 18 and 40 years (inclusive) with smoking habits as follows:
- between 18 and 30 years of age. daily cigarette consumption not above 10
- above 30 years of age, no smoking
Who cannot join
- Current signs of history of any forms of secondary dysmenorrhea
- Any concomitant disease of condition that requires any intake of analgesic medication
- Occurrence of less than six menstrual cycles before Visit 1 following delivery, abortion, or lactation
- Clinically significant depression
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
Germany24 sites
Study site
Berlin, State of Berlin, 10247
Study site
Berlin, State of Berlin, 10409
Study site
Berlin, State of Berlin, 12587
Study site
Berlin, State of Berlin, 13086
Study site
Bernburg, Saxony-Anhalt, 06406
Study site
Blankenburg, Saxony-Anhalt, 38889
Study site
Burg, Saxony-Anhalt, 39288
Study site
Frankfurt am Main, Hesse, 60439
Study site
Fulda, Hesse, 36037
Study site
Gera, Thuringia, 07545
Study site
Hanover, Lower Saxony, 30159
Study site
Hanover, Lower Saxony, 30459
Study site
Heidelberg, Baden-Wurttemberg, 69120
Study site
Jessen, Saxony-Anhalt, 06917
Study site
Kahla, Thuringia, 07768
Study site
Leipzig, Saxony, 04207
Study site
Leipzig, Saxony, 04277
Study site
Leipzig, Saxony, 04299
Study site
Magdeburg, Saxony-Anhalt, 39104
Study site
Magdeburg, Saxony-Anhalt, 39126
Study site
Magdeburg, Saxony-Anhalt, 39130
Study site
Mühlheim am Main, Hesse, 63165
Study site
Nuremberg, Bavaria, 90491
Study site
Wurzen, Saxony, 04808
United Kingdom3 sites
Study site
Chesterfield, Derbyshire, S40 4TF
Study site
London, W12 0HS
Study site
Newcastle upon Tyne, Tyne and Wear, NE4 5BE
About this study
Official title: A Multi-center, Open-label, Randomized, Controlled, Parallel-group Study to Assess Efficacy and Safety of an Extended Flexible Regimen of the Combined Oral Contraceptive SH T00186D (0.02 mg Ethinylestradiol as Beta-cyclodextrin Clathrate and 3 mg Drospirenone) Compared to the Conventional Regimen of SH T00186D in the Treatment of Primary Dysmenorrhea
The investigational drug SH T00186D is an oral contraceptive. The investigational drug used in this study contains the estrogen ethinylestradiol (EE) and the progestogen drospirenone (DRSP).
The aim of the present study is to evaluate efficacy and safety of the investigational drug in the treatment of menstrual pain (pelvic pain occurring shortly before, at onset, during menstruation). Two different regimens of intake of the same investigational product will be compared.
Read more
Patients have to undergo 2 -3 Baseline cycles (depending on whether the patient was an OC user before), during which menstrual pain, bleeding events, and pain killer intake have to be documented. During this observation period, the intake of hormonal contraceptives is not allowed. Other contraceptive methods (condoms with spermicide, pessary with spermicide) have to be used. If the patient is eligible for the study, she will be randomly assigned to one of the two treatment groups. Treatment group A will take the medication according to an extended flexible regimen, i.e., tablet intake will be triggered by bleeding events. Treatment group B will take the study medication in the 24 + 4 days regimen. That means, tablets to be taken on cycle days 1 - 24 contain the hormone combination, whereas tablets 25 - 28 do not contain any active ingredients, i.e., these are so called placebo tablets.
Treatment will last at least 140 days, but can be prolonged in Treatment Group A depending of occurrence of menstrual bleeding. The overall study duration will be 10 months for each patient.
During the whole study period, 5 visits are planned. At Screening and Final examination, a thorough physical examination and a gynecological examination (including breath palpation and cervical smear ) will be performed. Blood samples will be taken for safety laboratory parameters.
Additional examinations can be performed any time, if this becomes necessary for medical reasons.
Patients will be provided with a patient diary to document the intake of study medication, any bleeding events and days without bleeding, pregnancy test results, any dysmenorrheic (menstrual) pain and its intensity and its interference with daily activity, and intake of pain medication. The pain medication (ibuprofen) will be provided.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Drug: YAZ flex (SH T00186D), YAZ (SH T00186D)
- Keywords
- Primary Dysmenorrhea, Menstrual Pain, Oral Contraception
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: YAZ flex (SH T00186D)Drug
Extended flexible regimen of YAZ (SH T00186D); triggered by bleeding events(Tablet p.o. (oral))
YAZ (SH T00186D)Drug
YAZ (SH T 00186D) administered in the conventional regimen (24 days active + 4 days placebo) (Tablet p.o. (oral))
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Drug: YAZ flex (SH T00186D) |
| Arm 2 | Active comparator | Not described Receives: Drug: YAZ (SH T00186D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days with dysmenorrheic pain
Measured: 140 days
Secondary outcomes (8)
Use of rescue medication
Measured: 140 days
Interference with daily activity
Measured: 140 days
Number of days: with at least moderate dysmenorrheic pain
Measured: 140 days
Number of days with pelvic pain
Measured: 140 days
Number of days with dysmenorrheic pain associated with withdrawal bleeding
Measured: 140 days
Number of days with dysmenorrheic pain associated with unscheduled bleeding
Measured: 140 days
Bleeding patterns
Measured: Whole treatment period
Assessment of treatment
Measured: Whole treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 223 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
- NCT00569244
- Sponsor's protocol ID
- 91587
- Other IDs
- 2006-004899-13, 310882
- Status last verified
- Oct 2014
- First submitted
- 5 Dec 2007
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Strowitzki T, Kirsch B, Elliesen J. Efficacy of ethinylestradiol 20 mug/drospirenone 3 mg in a flexible extended regimen in women with moderate-to-severe primary dysmenorrhoea: an open-label, multicentre, randomised, controlled study. J Fam Plann Reprod Health Care. 2012 Apr;38(2):94-101. doi: 10.1136/jfprhc-2011-100225.
PubMed 22454006Schroll 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Randomized, Controlled, Parallel-group Study to Assess Efficacy and Safety of an Extended Flexible Regimen of the Combined Oral Contraceptive SH T00186D (0.02 mg Ethinylestradiol as Beta-cyclodextrin Clathrate and 3 mg Drospirenone) Compared to the Conventional Regimen of SH T00186D in the Treatment of Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT00569244
- Acronym / sponsor ID
- 91587
- Conditions
- Primary Dysmenorrhea
- Keywords
- Primary Dysmenorrhea, Menstrual Pain, Oral Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 7 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigational drug SH T00186D is an oral contraceptive. The investigational drug used in this study contains the estrogen ethinylestradiol (EE) and the progestogen drospirenone (DRSP).
The aim of the present study is to evaluate efficacy and safety of the investigational drug in the treatment of menstrual pain (pelvic pain occurring shortly before, at onset, during menstruation). Two different regimens of intake of the same investigational product will be compared.
Patients have to undergo 2 -3 Baseline cycles (depending on whether the patient was an OC user before), during which menstrual pain, bleeding events, and pain killer intake have to be documented. During this observation period, the intake of hormonal contraceptives is not allowed. Other contraceptive methods (condoms with spermicide, pessary with spermicide) have to be used. If the patient is eligible for the study, she will be randomly assigned to one of the two treatment groups. Treatment group A will take the medication according to an extended flexible regimen, i.e., tablet intake will be triggered by bleeding events. Treatment group B will take the study medication in the 24 + 4 days regimen. That means, tablets to be taken on cycle days 1 - 24 contain the hormone combination, whereas tablets 25 - 28 do not contain any active ingredients, i.e., these are so called placebo tablets.
Treatment will last at least 140 days, but can be prolonged in Treatment Group A depending of occurrence of menstrual bleeding. The overall study duration will be 10 months for each patient.
During the whole study period, 5 visits are planned. At Screening and Final examination, a thorough physical examination and a gynecological examination (including breath palpation and cervical smear ) will be performed. Blood samples will be taken for safety laboratory parameters.
Additional examinations can be performed any time, if this becomes necessary for medical reasons.
Patients will be provided with a patient diary to document the intake of study medication, any bleeding events and days without bleeding, pregnancy test results, any dysmenorrheic (menstrual) pain and its intensity and its interference with daily activity, and intake of pain medication. The pain medication (ibuprofen) will be provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Drug: YAZ flex (SH T00186D) |
| Arm 2 | Active comparator | Drug: YAZ (SH T00186D) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Otherwise healthy female patients with moderate to severe primary dysmenorrhea
- Prospective self-rated sum pain score of >/= 8 during the 2 baseline cycles
- Age between 18 and 40 years (inclusive) with smoking habits as follows:
Key exclusion criteria (4 listed)
- Current signs of history of any forms of secondary dysmenorrhea
- Any concomitant disease of condition that requires any intake of analgesic medication
- Occurrence of less than six menstrual cycles before Visit 1 following delivery, abortion, or lactation
- Clinically significant depression
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 |
|---|---|---|
| Drug: YAZ flex (SH T00186D)Extended flexible regimen of YAZ (SH T00186D); triggered by bleeding events(Tablet p.o. (oral)) | Drug | Arm 1 |
| YAZ (SH T00186D)YAZ (SH T 00186D) administered in the conventional regimen (24 days active + 4 days placebo) (Tablet p.o. (oral)) | Drug | Arm 2 |
Primary outcome
Number of days with dysmenorrheic pain
Time frame: 140 days
8 secondary outcomes
Use of rescue medication
Time frame: 140 days
Interference with daily activity
Time frame: 140 days
Number of days: with at least moderate dysmenorrheic pain
Time frame: 140 days
Number of days with pelvic pain
Time frame: 140 days
Number of days with dysmenorrheic pain associated with withdrawal bleeding
Time frame: 140 days
Number of days with dysmenorrheic pain associated with unscheduled bleeding
Time frame: 140 days
Bleeding patterns
Time frame: Whole treatment period
Assessment of treatment
Time frame: Whole treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
- Results publication: PubMed 22454006Strowitzki T, Kirsch B, Elliesen J. Efficacy of ethinylestradiol 20 mug/drospirenone 3 mg in a flexible extended regimen in women with moderate-to-severe primary dysmenorrhoea: an open-label, multicentre, randomised, controlled study. J Fam Plann Reprod Health Care. 2012 Apr;38(2):94-101. doi: 10.1136/jfprhc-2011-100225.
- 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.
- Click here and search for information of Bayer products for 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
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Drug: YAZ flex (SH T00186D) and YAZ (SH T00186D) in people with Primary Dysmenorrhea, run by Bayer at 27 sites in 2 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 4 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 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Germany, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of days with dysmenorrheic pain (time frame: 140 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 NCT00569244, 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 29 Oct 2014.