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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• 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; Ethinyl estradiol, levonorgestrel drug combination; Levonorgestrel; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Premenopausal

• Not pregnant or breastfeeding

• Agree to use back-up non-hormonal contraception for study period

Exclusion Criteria:

• Any contraindication to the use of oral contraceptives

• Pregnancy within the last 3 months

• Smoking >10 cigarettes per day