Drug Interaction - Oral Contraceptive

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to administer a combined oral contraceptive containing ethinyl estradiol and norgestimate with the HIV treatment of efavirenz to healthy females in order to assess if the concentrations of the oral contraceptives change. The safety of this treatment regimen will also be studied.

Key facts

Study ID

NCT00399685

Run by

Bristol-Myers Squibb

People needed

28

Starts

2006-12-01

Expected to finish

2007-08-01

Last updated by the study team

2011-04-14

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women of childbearing potential with intact ovarian function who have been on a stable method of oral contraceptives for at least 2 months prior to the start of the study.
• Documented acceptable Pap smear within 1 year of the start of the study
• BMI of 18-32 kg/m²

You may not qualify if…

• Males
• Subjects with abnormal menstrual cycle within 2 months prior to the start of the study
• History of conditions in which oral contraceptives are contraindicated
• History of migraine with focal aura
• History of uncontrolled hypertension
• Positive screening test for HIV-1,-2, HIV viral RNA, Hepatitis B surface antigen, or Hepatitis C antibody
• History of diagnosed mental illness or suicidal ideation

Where it is running

• Covance Clinical Research Unit San Diego — San Diego, California, United States
• Northwest Kinetics — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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