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Drug Interaction - Oral Contraceptive

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00399685
First received: November 14, 2006
Last updated: April 13, 2011
Last verified: April 2011
History of Changes
  Purpose
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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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.

  Eligibility
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399685

Locations
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
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

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:
HIV

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Contraceptive Agents
Norgestimate, ethinyl estradiol drug combination
Efavirenz
Moxifloxacin
Fluoroquinolones
Contraceptives, Oral
 Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers

ClinicalTrials.gov processed this record on September 29, 2016