Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive
Phase 3
Completed
- Conditions
- Contraception
- Interventions
- Drug: DR-1021
- Registration Number
- NCT00362479
- Lead Sponsor
- Duramed Research
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1347
Inclusion Criteria
- Premenopausal
- Not pregnant or breastfeeding
- Sexually active at risk of pregnancy
Exclusion Criteria
- Any contraindication to the use of oral contraceptives
- Pregnancy within the last 3 months
- Smoking > 10 cigarettes per day
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 DR-1021 -
- Primary Outcome Measures
Name Time Method Evaluation of pregnancy rates Duration of study
- Secondary Outcome Measures
Name Time Method Adverse events reported by patients and investigators Duration of study
Trial Locations
- Locations (1)
Duramed Investigational Site
🇺🇸Tacoma, Washington, United States