Drug Interaction - Oral Contraceptive

April 13, 2011 updated by: Bristol-Myers Squibb

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • Covance Clinical Research Unit San Diego
    • Washington
      • Tacoma, Washington, United States, 98418
        • Northwest Kinetics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A
Drug: Ortho Tri-Cyclen LO
Tablets, oral, OTC Lo 1 tab/daily (no dosage units), once daily, 28 days.
ACTIVE_COMPARATOR: B
Drug: Ortho Cyclen
Tablet, oral, Ortho Cyclen 1 tab/daily (no dosage units), once daily, 28 days.
Drug: Ortho Cyclen
Tablet, oral, OC 1 tab daily (no dosage units), once daily, 7 days.
ACTIVE_COMPARATOR: C
Drug: Ortho Cyclen + Efavirenz
Tablet, oral, OC + EFV 600 mg, once daily, 14 days.
Other Names:
  • Sustiva
ACTIVE_COMPARATOR: D
Drug: Ortho Cyclen
Tablet, oral, Ortho Cyclen 1 tab/daily (no dosage units), once daily, 28 days.
Drug: Ortho Cyclen
Tablet, oral, OC 1 tab daily (no dosage units), once daily, 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
throughout the study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (ACTUAL)

August 1, 2007

Study Completion (ACTUAL)

August 1, 2007

Study Registration Dates

First Submitted

November 14, 2006

First Submitted That Met QC Criteria

November 14, 2006

First Posted (ESTIMATE)

November 15, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 14, 2011

Last Update Submitted That Met QC Criteria

April 13, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI266-145

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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