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”

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.

Study Type: Interventional

Study Design: Other, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study

Intervention(s) in this Clinical Trial

• Drug: Ortho Tri-Cyclen LO
  • Tablets, oral, OTC Lo 1 tab/daily (no dosage units), once daily, 28 days.
• Drug: Ortho Cyclen
  • Tablet, oral, Ortho Cyclen 1 tab/daily (no dosage units), once daily, 28 days.
• Drug: Ortho Cyclen + Efavirenz
  • Tablet, oral, OC + EFV 600 mg, once daily, 14 days.
• Drug: Ortho Cyclen
  • Tablet, oral, OC 1 tab daily (no dosage units), once daily, 7 days.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Active Comparator: B
• Active Comparator: C
• Active Comparator: D

Primary Measures

• To determine the effect coadministration of efavirenz 600 mg on the pharmacokinetics of ethinyl estradiol and the metabolite of norgestimate
  • Time Frame: throughout the study
    

Secondary Measures

• Characterize the pharmacokinetics of efavirenz coadministered with the oral contraceptive Ortho Cyclen
  • Time Frame: throughout the study
    
• Assess the effect of efavirenz coadministered with Ortho Cyclen on serum progesterone levels
  • Time Frame: throughout the study
    
• Assess the safety of efavirenz coadministered with Ortho Cyclen
  • Time Frame: throughout the study
    

Inclusion Criteria:

• 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 Criteria:

• 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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Bristol-Myers Squibb

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00399685

Study ID Number: AI266-145

ClinicalTrials.gov Identifier: NCT00399685

Health Authority: United States: Food and Drug Administration

BMS Clinical Trials Disclosure

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