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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

November 14, 2006
April 13, 2011
December 2006
August 2007   (final data collection date for primary outcome measure)
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 ]
To determine the effect coadministration of efavirenz 600 mg on the pharmacokinetics of ethinyl estradiol and the metabolite of norgestimate
Complete list of historical versions of study NCT00399685 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Characterize the pharmacokinetics of efavirenz coadministered with the oral contraceptive Ortho Cyclen
  • Assess the effect of efavirenz coadministered with Ortho Cyclen on serum progesterone levels
  • Assess the safety of efavirenz coadministered with Ortho Cyclen
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
HIV Infections
  • Drug: Ortho Tri-Cyclen LO
    Tablets, oral, OTC Lo 1 tab/daily (no dosage units), once daily, 28 days.
  • Drug: Ortho Cyclen
    Tablet, oral, Ortho Cyclen 1 tab/daily (no dosage units), once daily, 28 days.
  • Drug: Ortho Cyclen + Efavirenz
    Tablet, oral, OC + EFV 600 mg, once daily, 14 days.
    Other Name: Sustiva
  • Drug: Ortho Cyclen
    Tablet, oral, OC 1 tab daily (no dosage units), once daily, 7 days.
  • Active Comparator: A
    Intervention: Drug: Ortho Tri-Cyclen LO
  • Active Comparator: B
    Intervention: Drug: Ortho Cyclen
  • Active Comparator: C
    Intervention: Drug: Ortho Cyclen + Efavirenz
  • Active Comparator: D
    Intervention: Drug: Ortho Cyclen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00399685
AI266-145
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP