Drug Interaction - Oral Contraceptive
Information provided by (Responsible Party)
First received: November 14, 2006
Last updated: April 13, 2011
Last Verified: April 2011
History of Changes
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.
Drug : Ortho Tri-Cyclen LO
Drug : Ortho Cyclen
Drug : Ortho Cyclen + Efavirenz
Drug : Ortho Cyclen
Intervention Model: Parallel Assignment
Masking: None (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|
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 ]
- 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 ]
|Study Start Date:||December 2006|
|Study Completion Date:||August 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
Ortho Tri-Cyclen LO
Tablets, oral, OTC Lo 1 tab/daily (no dosage units), once daily, 28 days.
Tablet, oral, Ortho Cyclen 1 tab/daily (no dosage units), once daily, 28 days.
Ortho Cyclen + Efavirenz
Tablet, oral, OC + EFV 600 mg, once daily, 14 days.
Other Name: Sustiva
Tablet, oral, OC 1 tab daily (no dosage units), once daily, 7 days.
|Ages Eligible for Study:||18 Years to 45 Years|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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 LocationsChoosing 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 Show More
|United States, California|
|Covance Clinical Research Unit San Diego|
|San Diego, California, United States, 92123|
|United States, Washington|
|Tacoma, Washington, United States, 98418|
Sponsors and CollaboratorsBristol-Myers Squibb
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|
Additional Information:BMS Clinical Trials Disclosure
Additional Information:For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
|Responsible Party:||Bristol-Myers Squibb|
|ClinicalTrials.gov Identifier:||NCT00399685 History of Changes|
|Other Study ID Numbers:||AI266-145|
|Study First Received:||November 14, 2006|
|Last Updated:||April 13, 2011|
Keywords provided by Bristol-Myers Squibb:HIV
Additional relevant MeSH terms:
Norgestimate, ethinyl estradiol drug combination
ClinicalTrials.gov processed this data on January 16, 2018
This information is provided by ClinicalTrials.gov.