A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021

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

Summary

This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen DR-1021.

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

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Treatments: Desogestrel; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Hormones; Oviol; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Premenopausal

• Weight <200 lbs

• Currently taking or willing to be treated with an oral contraceptive with a standard 21/7 regimen for one cycle prior to starting Study Cycle 1

• Others as dictated by protocol

Exclusion Criteria:

• Any contraindication to the use of oral contraceptives

• Breast feeding

• Smoking > 10 cigarettes per day

• Use of drugs that require simultaneous use of contraceptives (e.g., isotretinoin [Accutane])

• Others as dictated by protocol