Trial Condition(s):
Contraception
Yasmin 20 cycle control - Yasmin 20 versus Mercilon in healthy female volunteers
Bayer Identifier:
91352
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The purpose of this study is to compare bleeding pattern of contraceptive Yasmin 20 to a marketed comparator.
Inclusion Criteria
- Healthy female volunteer aged 18-35, - Smokers 18-30
Exclusion Criteria
- Contraindications for using hormonal contraceptives
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Väestöliiton Klinikat Oy Turku Turku, Finland, 20101 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ylioppilaiden terveydenhoitosäätiö, Helsinki Helsinki, Finland, 00260 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Geri-Med Oy Helsinki, Finland, 00100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Bernhard Poetsch Leibnitz, Austria, 8430 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. Doris Gruber Wien, Austria, 1050 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. Norman Ruth Woergl, Austria, 6300 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations G. Karpenko Private Clinic Vilnius, Lithuania, 2035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Public outpatient clinic Centro Vilnius, Lithuania, 01118 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UAB Via Medica Kaunas, Lithuania, 3043 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tampereen Terveyskeskus Tampere, Finland, 33200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Sigrid Schmidl-Amann St. Poelten, Austria, 3100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. Wollein Moedling, Austria, 2340 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SATUE Kliinikumi Naistekliinik Tartu, Estonia, 51003 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Youth and Women's Centre Paernu, Estonia, 80010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medicover Eesti AS Talinn, Estonia, 10145 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations VAKK Ltd. A. Kildas Private Clinic Kaunas, Lithuania, 3042 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seimos meicinos centras (Private medical centre) Vilnius, Lithuania, 01118 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Private Clinic Horn, Austria, 3580 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Cycle control and bleeding patternTimeframe: 7 cycles
Secondary Outcome
- Pearl indexTimeframe: 7 cycles
- Laboratory testsTimeframe: Screening
- Adverse EventsTimeframe: 7 cycles
- General Physical and gynecological examinationsTimeframe: Screening
- Vital signsTimeframe: Screening, admission
- Body weightTimeframe: Screening, admission
Additional Information
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