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
1 other identifier
interventional
28
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hiv-infections
Started Dec 2006
Shorter than P25 for phase_1 hiv-infections
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2006
CompletedFirst Posted
Study publicly available on registry
November 15, 2006
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedApril 14, 2011
April 1, 2011
8 months
November 14, 2006
April 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the effect coadministration of efavirenz 600 mg on the pharmacokinetics of ethinyl estradiol and the metabolite of norgestimate
throughout the study
Secondary Outcomes (3)
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
Study Arms (4)
A
ACTIVE COMPARATORB
ACTIVE COMPARATORC
ACTIVE COMPARATORD
ACTIVE COMPARATORInterventions
Tablet, oral, OC + EFV 600 mg, once daily, 14 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Covance Clinical Research Unit San Diego
San Diego, California, 92123, United States
Northwest Kinetics
Tacoma, Washington, 98418, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 14, 2006
First Posted
November 15, 2006
Study Start
December 1, 2006
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
April 14, 2011
Record last verified: 2011-04