Status:
COMPLETED
Drug Interaction - Oral Contraceptive
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
HIV Infections
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00399685
Start Date
December 1 2006
End Date
August 1 2007
Last Update
April 14 2011
Active Locations (2)
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1
Covance Clinical Research Unit San Diego
San Diego, California, United States, 92123
2
Northwest Kinetics
Tacoma, Washington, United States, 98418