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

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Duramed Research
• Treatments: Contraceptive Agents; Contraceptives, Oral; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Levonorgestrel; Polyestradiol phosphate

Criteria

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