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OpenTrials
Completed

NCT Number: NCT00399685

Drug Interaction - Oral Contraceptive

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ortho Tri-cyclen Lo

Drug

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

Ortho Cyclen

Drug

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

Ortho Cyclen + Efavirenz

Drug

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

Other names: Sustiva

Primary outcomes

  1. 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

Secondary outcomes

  1. Characterize the pharmacokinetics of efavirenz coadministered with the oral contraceptive Ortho Cyclen

    Time frame: throughout the study

  2. Assess the effect of efavirenz coadministered with Ortho Cyclen on serum progesterone levels

    Time frame: throughout the study

  3. Assess the safety of efavirenz coadministered with Ortho Cyclen

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 15, 2006
Registry last updated
Apr 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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