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Drug Interaction - Oral Contraceptive

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Ortho Tri-Cyclen LO (Drug); Ortho Cyclen (Drug); Ortho Cyclen + Efavirenz (Drug); Ortho Cyclen (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

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

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

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 and Contacts

Covance Clinical Research Unit San Diego, San Diego, California 92123, United States

Northwest Kinetics, Tacoma, Washington 98418, United States

Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: December 2006
Last updated: April 13, 2011

Page last updated: August 23, 2015

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