Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive
Sponsored by Duramed Research
About this trial
Last updated 12 years ago
Study ID
DR-DSG-301
Status
Completed
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
18 to 45 Years
Female
Trial Timing
Ended 18 years ago
What is this trial about?
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.
What are the participation requirements?
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