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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00624130 |
The purpose of this study is to compare bleeding pattern of contraceptive Yasmin 20 to a marketed comparator.
Condition | Intervention | Phase |
---|---|---|
Contraception |
Drug: Yasmin 20 Drug: Mercilon |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Open, Randomized, Parallel Multi-Center Comparison of Cycle Control and Safety of the Oral Contraceptive Yasmin 20 in a 24-Day Regimen vs. Mercilon for 7 Cycles in 440 Healthy Female Volunteers |
Enrollment: | 440 |
Study Start Date: | March 2004 |
Study Completion Date: | June 2005 |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Yasmin 20
Yasmin 20, 24-d regimen vs Mercilon, Tablet p.o. (oral)
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Arm 2: Active Comparator |
Drug: Mercilon
Mercilon, 24-d regimen vs Yasmin 20 , Tablet p.o. (oral)
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Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Leibnitz, Austria, 8430 | |
Wien, Austria, 1050 | |
St. Poelten, Austria, 3100 | |
Moedling, Austria, 2340 | |
Woergl, Austria, 6300 | |
Horn, Austria, 3580 | |
Estonia | |
Tartu, Estonia, 51003 | |
Paernu, Estonia, 80010 | |
Talinn, Estonia, 10145 | |
Finland | |
Turku, Finland, 20101 | |
Helsinki, Finland, 00260 | |
Tampere, Finland, 33200 | |
Helsinki, Finland, 00100 | |
Lithuania | |
Kaunas, Lithuania, 3043 | |
Vilnius, Lithuania, 01118 | |
Vilnius, Lithuania, 2035 | |
Kaunas, Lithuania, 3042 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Schering Pharma AG ( Therapeutic Area Head ) |
Study ID Numbers: | 91352, 308020 |
Study First Received: | February 18, 2008 |
Last Updated: | May 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00624130 History of Changes |
Health Authority: | Finland: National Agency for Medicines; Estonia: The State Agency of Medicine; Lithuania: State Medicine Control Agency - Ministry of Health; Austria: Federal Ministry for Health and Women; United States: Institutional Review Board |
Contraception, Cycle control, Bleeding pattern |
Contraceptive Agents Contraceptives, Oral Healthy Hemorrhage |