NCT00362479

Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive

A Prospective, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of the 28-Day Oral Contraceptive DR-1021

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,347 (actual)
• Sponsor: Duramed Research · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, single treatment study. All subjects will receive 6 months of oral contraceptive therapy with DR-1021. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Detailed description

The overall study duration for each patient will be approximately 8 months, which includes a screening period of approximately 4 weeks; a treatment period of approximately six months (six,28-day cycles); and a follow-up visit approximately 4 weeks after completion of study drug.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	DR-1021	1 tablet daily

Timeline

• Start date: 2006-08-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2006-08-10
• Last updated: 2013-08-21

Locations

85 sites across 1 country: United States