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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the contraceptive efficacy of dienogest and ethinylestradiol in NCT00302666?
How does the 84-day extended regimen of Valette compare to conventional 21-day OCs in cycle control and bleeding patterns?
Are there specific biomarkers that predict individual response to dienogest/ethinylestradiol combination therapy in contraceptive use?
What are the potential adverse events associated with long-term use of 0.03 mg EE and 2 mg dienogest in oral contraceptives?
How does Valette's progestin-only mechanism compare to other combined oral contraceptives in terms of metabolic effects and safety profiles?