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Drug Interaction - Oral Contraceptive

NCT00399685 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2011-04-14

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

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.

DRUG

Ortho Cyclen

Tablet, oral, OC 1 tab daily (no dosage units), once daily, 7 days.

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00399685 on ClinicalTrials.gov