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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

18-75 Years
18 to 45 Years
Female
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?

Yes

Inclusion Criteria

- Premenopausal

- Not pregnant or breastfeeding

- Sexually active at risk of pregnancy

No

Exclusion Criteria

- Any contraindication to the use of oral contraceptives

- Pregnancy within the last 3 months

- Smoking > 10 cigarettes per day