Drug Interaction - Oral Contraceptive
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Ortho Tri-Cyclen LO (Drug); Ortho Cyclen (Drug); Ortho Cyclen + Efavirenz (Drug); Ortho Cyclen (Drug)
Phase: Phase 1
Sponsored by: Bristol-Myers Squibb
Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
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.
Official title: Study to Evaluate the Effect of Efavirenz Coadministration on the Pharmacokinetics of the Active Moieties of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects
Study design: Other, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study
Primary outcome: To determine the effect coadministration of efavirenz 600 mg on the pharmacokinetics of ethinyl estradiol and the metabolite of norgestimate
Characterize the pharmacokinetics of efavirenz coadministered with the oral contraceptive Ortho Cyclen
Assess the effect of efavirenz coadministered with Ortho Cyclen on serum progesterone levels
Assess the safety of efavirenz coadministered with Ortho Cyclen
Minimum age: 18 Years.
Maximum age: 45 Years.
- 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
- Subjects with abnormal menstrual cycle within 2 months prior to the start of the
- 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
Locations and Contacts
Covance Clinical Research Unit San Diego, San Diego, California 92123, United States
Northwest Kinetics, Tacoma, Washington 98418, United States
BMS Clinical Trials Disclosure
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Starting date: December 2006
Ending date: August 2007
Last updated: June 2, 2008