Drug Interaction - Oral Contraceptive

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Drug: Ortho Cyclen; Drug: Ortho Tri-Cyclen LO; Drug: Ortho Cyclen + Efavirenz

• Registration Number: NCT00399685
• Lead Sponsor: Bristol-Myers Squibb

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 concentrations of the oral contraceptives change. The safety of this treatment regimen will also be studied.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-11-14
• Study First Submitted QC: 2006-11-14
• Study First Posted: 2006-11-15
• Study Start: 2006-12
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-13
• Last Update Posted: 2011-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D	Ortho Cyclen	-
A	Ortho Tri-Cyclen LO	-
B	Ortho Cyclen	-
C	Ortho Cyclen + Efavirenz	-

Primary Outcome Measures

Name	Time	Method
To determine the effect coadministration of efavirenz 600 mg on the pharmacokinetics of ethinyl estradiol and the metabolite of norgestimate	throughout the study

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Covance Clinical Research Unit San Diego; 🇺🇸 San Diego, California, United States

Northwest Kinetics; 🇺🇸 Tacoma, Washington, United States