Drug Interaction - Oral Contraceptive - Tabular View

Tracking Information

First Received Date ^ICMJE

November 14, 2006

Last Updated Date

October 9, 2008

Start Date ^ICMJE

December 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

To determine the effect coadministration of efavirenz 600 mg on the pharmacokinetics of ethinyl estradiol and the metabolite of norgestimate

Change History

Complete list of historical versions of study NCT00399685 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Drug Interaction - Oral Contraceptive

Official Title ^ICMJE

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

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Ortho Tri-Cyclen LO
Drug: Ortho Cyclen
Drug: Ortho Cyclen + Efavirenz

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00399685

Responsible Party

Study ID Numbers ^ICMJE

AI266-145

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP