Drug Interaction - Oral Contraceptive

Bristol-Myers Squibb28 enrolled

Overview

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

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

Ortho Tri-Cyclen LODRUG

Tablets, oral, OTC Lo 1 tab/daily (no dosage units), once daily, 28 days.

Ortho CyclenDRUG

Tablet, oral, Ortho Cyclen 1 tab/daily (no dosage units), once daily, 28 days.

Ortho Cyclen + EfavirenzDRUG

Tablet, oral, OC + EFV 600 mg, once daily, 14 days.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Covance Clinical Research Unit San Diego

San Diego, California, United States

Northwest Kinetics

Tacoma, Washington, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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