NCT00302666

Bleeding Pattern Study

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,315 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Oral Contraceptive

Interventions

Type	Name	Description
DRUG	Valette (Dienogest/EE30, BAY86-5038)	Oral contraceptive extended cycles
DRUG	Valette (Dienogest/EE30, BAY86-5038)	Oral contraceptive conventional cycles

Timeline

• Start date: 2003-06-01
• Completion: 2005-02-01
• First posted: 2006-03-14
• Last updated: 2009-05-18

Locations

48 sites across 1 country: Germany