Drug Interaction - Oral Contraceptive

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00399685

Enrollment

Registered

2006-11-15

Start date

2006-12-31

Completion date

2007-08-31

Last updated

2011-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV

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.

Interventions

DRUGOrtho Tri-Cyclen LO

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

DRUGOrtho Cyclen

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

DRUGOrtho Cyclen + Efavirenz

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026