NCT00996580

A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy

A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of a Combination Oral Contraceptive Regimen (DR-103) for the Prevention of Pregnancy in Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,597 (actual)
• Sponsor: Teva Women's Health · 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-103. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Conditions

• Pregnancy Prevention

Interventions

Type	Name	Description
DRUG	DR-103	One tablet daily. Four 91-day cycles of the DR-103 regimen: 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by; 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by; 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by; 7 days of 10 mcg EE.

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2009-10-16
• Last updated: 2013-06-24
• Results posted: 2013-06-14

Locations

94 sites across 1 country: United States