- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00266032
Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles
October 27, 2014 updated by: Bayer
A Multicenter, Open, Randomized, Parallel Group Comparison to Assess the Safety and Efficacy of the Oral Contraceptive SH T00186D (0.02 mg Ethinylestradiol as Betadex Clathrate and 3 mg Drospirenone) in Two Variations of an Extended Regimen vs. a Standard Regimen (24 + 4 Days) in 1122 Healthy Female Volunteers for One Year, Followed by a One Year Safety Extension
The purpose of the study is to determine safety and efficacy of long-cycle regimens of an oral contraceptive.
Study Overview
Status
Completed
Conditions
Detailed Description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG (BSP AG), Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
The previously posted secondary Outcome Measure "Parameters of safety and tolerability" has been removed from result posting as it is covered by the Adverse Event section.
Study Type
Interventional
Enrollment (Actual)
1166
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec, Canada, G1S 2L6
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Quebec
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Drummondville, Quebec, Canada, J2B 1H8
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Montreal, Quebec, Canada, H1T 1P6
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Pointe-Claire, Quebec, Canada, H9R 4S3
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Shawinigan, Quebec, Canada, G9N 2H6
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Ste-Foy, Quebec, Canada, G1V 4X7
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Berlin, Germany, 10115
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Berlin, Germany, 13187
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Berlin, Germany, 10247
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Berlin, Germany, 12435
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Hamburg, Germany, 21073
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Baden-Württemberg
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Ettlingen, Baden-Württemberg, Germany, 76275
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Karlsruhe, Baden-Württemberg, Germany, 76199
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Bayern
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Ansbach, Bayern, Germany, 91522
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Krumbach, Bayern, Germany, 86381
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Nürnberg, Bayern, Germany, 90491
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Hessen
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Dietzenbach, Hessen, Germany, 63128
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Frankfurt, Hessen, Germany, 60322
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Frankfurt, Hessen, Germany, 65929
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Frankfurt, Hessen, Germany, 65936
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Frankfurt, Hessen, Germany, 60439
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Mühlheim, Hessen, Germany, 63165
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Niedersachsen
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Bovenden, Niedersachsen, Germany, 37120
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Hannover, Niedersachsen, Germany, 30459
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Osnabrück, Niedersachsen, Germany, 49074
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Sachsen
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Wurzen, Sachsen, Germany, 04808
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Sachsen-Anhalt
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Bernburg, Sachsen-Anhalt, Germany, 06406
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Jessen, Sachsen-Anhalt, Germany, 06917
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Magdeburg, Sachsen-Anhalt, Germany, 39126
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Magdeburg, Sachsen-Anhalt, Germany, 39104
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Magdeburg, Sachsen-Anhalt, Germany, 39130
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Thüringen
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Gera, Thüringen, Germany, 07545
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Jena, Thüringen, Germany, 07747
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Kahla, Thüringen, Germany, 07768
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Groningen, Netherlands, 9713 GZ
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Healthy women who desire contraception
- smokers ≤ 30 Years old
Exclusion Criteria:
- Contraindication against use of hormonal contraceptives
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300)
3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval.
If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised.
The minimum period between 2 tablet free intervals was 24 days.
After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
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3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval.
If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised.
The minimum period between 2 tablet free intervals was 24 days.
After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
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Experimental: Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300)
3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
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3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
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Active Comparator: Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
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13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Days With Bleeding Including Spotting
Time Frame: up to 1 year
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The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity spotting or worse.
The primary evaluation was the comparison of the flexible extended vs the standard regimen for this primary target variable, which was done for data within the first year of treatment only.
As no further comparison or testing was done, no multiplicity issue arose.
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up to 1 year
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Number of Unintended Pregnancies in Yaz Flexible Arm
Time Frame: up to 2 years
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Pregnancies with conception date within 4 days after end of study medication were regarded as during treatment.
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up to 2 years
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Pearl Index
Time Frame: Up to 2 years
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The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.
The 2-year PI was obtained by dividing the number of pregnancies that occurred during the two years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant.
95% confidence interval according to European Medicine Agency Note for guidance on clinical investigation of steroid contraceptives in women.
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Up to 2 years
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Number of Unintended Pregnancies Due to Method Failure
Time Frame: Up to 2 years
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Not included in this analysis are pregnancies due to subject failure eg.
non-compliance with tablet intake rules.
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Up to 2 years
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Adjusted Pearl Index
Time Frame: Up to 2 years
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The adjusted Pearl Index was based on pregnancies due to method failures and compliant treatment cycles, i.e. cycle length between 24 and 124 day, pill break not longer than 7 days, and number of pills taken not smaller than 90% of the number of days in that cycle minus 7 days.
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Up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Days With Bleeding Excluding Spotting
Time Frame: up to 1 year
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The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity light, normal, or heavy.
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up to 1 year
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Number of Bleeding Days During One Year of Treatment in Subjects With at Least 248 Days of Exposure Normalized to 372 Days
Time Frame: up to 1 year
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For early dropouts and pregnant subjects with an exposure period of less than 1 year but at least 248 days, the number of bleeding/spotting days was normalized to correspond to a 1-year exposure period.
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up to 1 year
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Number of Bleeding / Spotting Days by 90-day Reference Period
Time Frame: up to 1 year
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The mean number of bleeding / spotting days, spotting-only and bleeding days was analyzed using reference periods of 90 days as recommended by the WHO.
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up to 1 year
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Number of Bleeding / Spotting Episodes in 90 Day Reference Period
Time Frame: Up to one year
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The mean number of bleeding / spotting episodes was analyzed using reference periods of 90 days as recommended by the WHO.
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Up to one year
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Days With Scheduled Versus Unscheduled Bleeding
Time Frame: Up to one year
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Days with scheduled and unscheduled bleeding were evaluated for extended regimens only.
Unscheduled is any bleeding/spotting that occurred while taking active hormones regardless of the duration of intake, unless they occurred after tablet-free interval during days 1-4 of subsequent treatment cycle, or unless they occurred during days 1-7 of first treatment cycle.
Scheduled is any bleeding/spotting that occurred during tablet-free interval, regardless of duration of tablet intake, or during next 4 days of subsequent treatment cycle.
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Up to one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Klipping C, Duijkers I, Fortier MP, Marr J, Trummer D, Elliesen J. Long-term tolerability of ethinylestradiol 20 mug/drospirenone 3 mg in a flexible extended regimen: results from a randomised, controlled, multicentre study. J Fam Plann Reprod Health Care. 2012 Apr;38(2):84-93. doi: 10.1136/jfprhc-2011-100214.
- Klipping C, Duijkers I, Fortier MP, Marr J, Trummer D, Elliesen J. Contraceptive efficacy and tolerability of ethinylestradiol 20 mug/drospirenone 3 mg in a flexible extended regimen: an open-label, multicentre, randomised, controlled study. J Fam Plann Reprod Health Care. 2012 Apr;38(2):73-83. doi: 10.1136/jfprhc-2011-100213.
- Reif S, Snelder N, Blode H. Characterisation of the pharmacokinetics of ethinylestradiol and drospirenone in extended-cycle regimens: population pharmacokinetic analysis from a randomised Phase III study. J Fam Plann Reprod Health Care. 2013 Apr;39(2):e1-13. doi: 10.1136/jfprhc-2012-100397.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
December 14, 2005
First Submitted That Met QC Criteria
December 14, 2005
First Posted (Estimate)
December 15, 2005
Study Record Updates
Last Update Posted (Estimate)
November 2, 2014
Last Update Submitted That Met QC Criteria
October 27, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 91450
- 2005-002125-32 (EudraCT Number)
- 308683 (Other Identifier: Company Internal)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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