NCT01178125

A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy

A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of a Combination Oral Contraceptive Regimen (DR-102) for the Prevention of Pregnancy in Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,858 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, single treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-102. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a daily diary.

Conditions

• Contraception
• Female Contraception

Interventions

Type	Name	Description
DRUG	DR-102

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2010-08-09
• Last updated: 2021-11-09
• Results posted: 2013-12-11

Locations

62 sites across 2 countries: United States, Israel