Drug Interaction - Oral Contraceptive

This study has been completed.
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
First received: November 14, 2006
Last updated: April 13, 2011
Last verified: April 2011
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.

Condition Intervention Phase
HIV Infections
Drug: Ortho Tri-Cyclen LO
Drug: Ortho Cyclen
Drug: Ortho Cyclen + Efavirenz
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 28
Study Start Date: December 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Ortho Tri-Cyclen LO
Tablets, oral, OTC Lo 1 tab/daily (no dosage units), once daily, 28 days.
Active Comparator: B Drug: Ortho Cyclen
Tablet, oral, Ortho Cyclen 1 tab/daily (no dosage units), once daily, 28 days.
Active Comparator: C Drug: Ortho Cyclen + Efavirenz
Tablet, oral, OC + EFV 600 mg, once daily, 14 days.
Other Name: Sustiva
Active Comparator: D Drug: Ortho Cyclen
Tablet, oral, OC 1 tab daily (no dosage units), once daily, 7 days.


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00399685

United States, California
Covance Clinical Research Unit San Diego
San Diego, California, United States, 92123
United States, Washington
Northwest Kinetics
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00399685     History of Changes
Other Study ID Numbers: AI266-145 
Study First Received: November 14, 2006
Last Updated: April 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antineoplastic Agents
Antiviral Agents
Contraceptive Agents, Female
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Physiological Effects of Drugs
Reproductive Control Agents
Reverse Transcriptase Inhibitors
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016