Bleeding Pattern Study
Phase 3
Completed
- Conditions
- Oral Contraceptive
- Interventions
- Drug: Valette (Dienogest/EE30, BAY86-5038)
- Registration Number
- NCT00302666
- Lead Sponsor
- Bayer
- Brief Summary
The aim of this study is to evaluate bleeding pattern, cycle control, contraceptive efficacy and safety of this oral contraceptive in two different regimens of intake.
- Detailed Description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1315
Inclusion Criteria
- Healthy female volunteers aged between 18 and 40 years requiring contraception.
Exclusion Criteria
- Pregnancy or lactation.
- Any conditions that might interfere with the outcome as well as all contraindications for OC use.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Valette (Dienogest/EE30, BAY86-5038) - Arm 2 Valette (Dienogest/EE30, BAY86-5038) -
- Primary Outcome Measures
Name Time Method Bleeding pattern
- Secondary Outcome Measures
Name Time Method Safety, contraceptive efficacy