Drug Interaction - Oral Contraceptive

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399685
• Other study ID #: AI266-145
• Status: Completed
• Phase: Phase 1
• First received: November 14, 2006
• Last updated: April 13, 2011
• Start date: December 2006
• Est. completion date: August 2007

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Ortho Tri-Cyclen LO
Tablets, oral, OTC Lo 1 tab/daily (no dosage units), once daily, 28 days.
• Ortho Cyclen
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.
• Ortho Cyclen
Tablet, oral, OC 1 tab daily (no dosage units), once daily, 7 days.

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit San Diego	San Diego	California
United States	Northwest Kinetics	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the effect coadministration of efavirenz 600 mg on the pharmacokinetics of ethinyl estradiol and the metabolite of norgestimate		throughout the study
Secondary	Characterize the pharmacokinetics of efavirenz coadministered with the oral contraceptive Ortho Cyclen		throughout the study
Secondary	Assess the effect of efavirenz coadministered with Ortho Cyclen on serum progesterone levels		throughout the study
Secondary	Assess the safety of efavirenz coadministered with Ortho Cyclen		throughout the study

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm