NCT00302666
Completed
Phase 3
Comparative, Prospective, Multi-Center, Open, Randomized Study to Investigate Bleeding Patterns, Metabolic Effects, Contraceptive Efficacy, Acceptance, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 2 mg Dienogest, in Two Different Regimens of Intake (Four Extended Cycles of 84 Days Each Versus the Conventional Regimen of 21 Days) in Healthy Volunteers
ConditionsOral Contraceptive
InterventionsValette (Dienogest/EE30, BAY86-5038)
Overview
- Phase
- Phase 3
- Intervention
- Valette (Dienogest/EE30, BAY86-5038)
- Conditions
- Oral Contraceptive
- Sponsor
- Bayer
- Enrollment
- 1315
- Primary Endpoint
- Bleeding pattern
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Arm 1
Intervention: Valette (Dienogest/EE30, BAY86-5038)
Arm 2
Intervention: Valette (Dienogest/EE30, BAY86-5038)
Outcomes
Primary Outcomes
Bleeding pattern
Secondary Outcomes
- Safety, contraceptive efficacy
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