Trial Condition(s):
Contraception
Study on safety and efficacy of an oral contraceptive in long cycles
Bayer Identifier:
91450
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The purpose of the study is to determine safety and efficacy of long-cycle regimens of an oral contraceptive.
Inclusion Criteria
- Healthy women who desire contraception - smokers ≤ 30 Years old
Exclusion Criteria
- Contraindication against use of hormonal contraceptives
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Praxis Hr. Dr. U. Kohoutek Karlsruhe, Germany, 76199 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kreiskrankenhaus Krumbach Krumbach, Germany, 86381 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. L. Weihe Ansbach, Germany, 91522 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dinox GmbH Berlin Berlin, Germany, 10115 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Hr. Dr. H. Lindecke Berlin, Germany, 10247 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. B. Wernecke Berlin, Germany, 12435 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Dr. med. Wolfram Brach Dietzenbach, Germany, 63128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. S. El Tobgui-Jensen Frankfurt, Germany, 60439 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. Werner Göttker-Schnetmann Frankfurt , Germany, 60322 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. P. Schwaner Frankfurt, Germany, 65936 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. J. Tyagi Mühlheim, Germany, 63165 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. H. Frommeyer Osnabrück, Germany, 49074 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. H. Zabel Bovenden, Germany, 37120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. H. Thelen Jessen, Germany, 06917 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. A. Soder Ettlingen, Germany, 76275 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. R. Kuett Nürnberg, Germany, 90491 | Status Completed | Contact Us: E-mail: cl[email protected] Phone: Not Available |
Locations Frauenarztpraxis Hr. Dr. B. Hamann Berlin, Germany, 13187 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. D. Rautenberg Hamburg, Germany, 21073 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. S. Clauss-Hoffmann Frankfurt, Germany, 65929 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. K. Greven Hannover, Germany, 30459 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. I. Gröger Wurzen, Germany, 04808 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Prof. Dr. H.-J. Ahrendt Magdeburg, Germany, 39126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. A. Braune Magdeburg, Germany, 39104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. A. Heweker Bernburg, Germany, 06406 | Status Completed | Contact Us: E-mail: clinical-trials-conta[email protected] Phone: Not Available |
Locations Praxis Hr. Dr. R. Etzrodt Gera, Germany, 07545 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dinox B.V. Groningen, Netherlands, 9713 GZ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Médicale des Campus Ste-Foy, Canada, G1V 4X7 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique de Gynecologie Shawinigan, Canada, G9N 2H6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Dr. med. Gabriele Weinreich Magdeburg, Germany, 39130 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. S. Krepler Jena, Germany, 07747 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. A.Mönch-Hering Kahla, Germany, 07768 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. R. Wähnert Gera, Germany, 07545 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Recherche en Sante des Femmes Inc. Quebec, Canada, G1S 2L6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre d'étude clinique de Montréal Inc. Montreal, Canada, H1T 1P6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rhodin Recherche Clinique Drummondville, Canada, J2B 1H8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kells Medical Research Group, Inc. Pointe-Claire, Canada, H9R 4S3 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Number of days with bleeding including spottingTimeframe: up to 1 year
- Number of unintended pregnancies in Yaz flexible armTimeframe: up to 2 years
- Pearl IndexTimeframe: Up to 2 years
- Number of unintended pregnancies due to method failureTimeframe: Up to 2 years
- Adjusted Pearl indexTimeframe: Up to 2 years
Secondary Outcome
- Number of days with bleeding exluding spottingTimeframe: up to 1 year
- Number of bleeding days during one year of treatment in subjects with at least 248 days of exposure normalized to 372 daysTimeframe: up to 1 year
- Number of bleeding / spotting days by 90-day reference periodTimeframe: up to 1 year
- Number of bleeding / spotting episodes in 90 day reference periodTimeframe: Up to one year
- Days with scheduled versus unscheduled bleedingTimeframe: Up to one year
Additional Information
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