Overview

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