NCT00791297

Study to Evaluate the Safety and Efficacy of Two Contraceptive Vaginal Rings Delivering a Daily Dose of 1500 or 2500 μg of CDB-2914

A Phase 2, Randomized Study to Evaluate the Safety and Efficacy of Two Contraceptive Vaginal Rings Delivering a Daily Dose of 1500 or 2500 μg of CDB-2914 on Inhibition of Ovulation, Endometrial Changes and Bleeding Patterns in Normal Cycling Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Population Council · Academic / Other
• Sex: Female
• Age: 21 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to to determine pharmacodynamic effects of a vaginal ring delivering either 1,500 or 2,500 μg of CDB-2914 per day during 6 months of treatment on: 1. follicular function and inhibition of ovulation 2. the endometrium 3. bleeding patterns; and also to assess safety including effects on the endometrium

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	CDB-2914	Contraceptive Vaginal Rings delivering a daily dose of 1500 or 2500 μg of CDB-2914

Timeline

• Start date: 2008-10-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2008-11-14
• Last updated: 2017-08-15

Locations

3 sites across 3 countries: United States, Chile, Dominican Republic