NCT00394771

A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale

A Prospective, Multicenter, Double-Blinded, Randomized Study to Evaluate Bleeding Patterns in Women Using One of Three Different Doses of DR-1031 Oral Contraceptive Compared to Seasonale Oral Contraceptive Regimen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 567 (actual)
• Sponsor: Duramed Research · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a 4-arm study to evaluate and compare bleeding patterns between three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive. 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

This Phase 2, prospective, multicenter, double-blinded, randomized study is designed to evaluate and compare bleeding patterns in women using one of three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive. Patients who meet all study entrance criteria will be randomly assigned to one of four treatment groups, The overall study duration will be approximately 9 months; this will include a screening period of approximately 4 weeks, a run-in period of 4 weeks, a treatment period of approximately 6 months (two,91-day cycles) and a final study visit occurring 14-21 days after completion of study drug.

Conditions

• Breakthrough Bleeding

Interventions

Type	Name	Description
DRUG	DR-1031	Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm.
DRUG	Seasonale®	84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets for two consecutive 91-day cycles.
DRUG	Portia®	Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2006-11-01
• Last updated: 2013-07-26
• Results posted: 2013-06-19

Locations

50 sites across 1 country: United States