Who is sponsoring NCT00399685?

NCT00399685 is sponsored by Bristol-Myers Squibb.

What condition does NCT00399685 study?

NCT00399685 studies HIV Infections.

What drugs are being tested in NCT00399685?

Interventions: Ortho Tri-Cyclen LO, Ortho Cyclen, Ortho Cyclen + Efavirenz, Ortho Cyclen.

What is the status of NCT00399685?

NCT00399685 is currently COMPLETED.

Last reviewed 2011-04-13 · How we verify

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

NCT00399685 Phase 1 COMPLETED

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.

Details

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1
Status	COMPLETED
Enrolment	28
Start date	2006-12
Completion	2007-08

Conditions

HIV Infections

Interventions

Ortho Tri-Cyclen LO
Ortho Cyclen
Ortho Cyclen + Efavirenz
Ortho Cyclen

Primary outcomes

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

Countries

United States