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

Completed · Phase 3 · Has a placebo group

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT00544882

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

61

Starts

2007-10-31

Expected to finish

2008-03-31

Last updated by the study team

2021-11-18

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Duramed Investigational Site — Lawrenceville, New Jersey, United States
• Duramed Investigational Site — Columbus, Ohio, United States
• Duramed Investigational Site — Philadelphia, Pennsylvania, United States
• Duramed Investigational Site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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