NCT00196326

Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive

A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose, Combination Oral Contraceptive, Which Utilizes Ethinyl Estradiol During the Seven Day Interval Between Each 84-day Cycle

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,235 (actual)
• Sponsor: Duramed Research · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, single treatment study. All subjects will receive one year of oral contraceptive therapy with DR-1011. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	DR-1011	Eighty-four orange, embossed tablets, each containing 100 μg levonorgestrel (LNG) / 20 μg ethinyl estradiol (EE) and 7 yellow, embossed tablets, each containing 10 μg of EE. One combination tablet was to be taken each day for 84 days followed by 7 days of EE tablets in 91-day cycles repeated consecutively for approximately one year (four 91-day cycles).

Timeline

• Start date: 2005-06-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2005-09-20
• Last updated: 2016-11-16
• Results posted: 2009-04-15

Locations

55 sites across 1 country: United States