Drug Interaction - Oral Contraceptive

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Ortho Tri-Cyclen LO

Intervention Type DRUG

Tablets, oral, OTC Lo 1 tab/daily (no dosage units), once daily, 28 days.

B

Group Type ACTIVE_COMPARATOR

Ortho Cyclen

Intervention Type DRUG

Tablet, oral, Ortho Cyclen 1 tab/daily (no dosage units), once daily, 28 days.

C

Group Type ACTIVE_COMPARATOR

Ortho Cyclen + Efavirenz

Intervention Type DRUG

Tablet, oral, OC + EFV 600 mg, once daily, 14 days.

D

Group Type ACTIVE_COMPARATOR

Ortho Cyclen

Intervention Type DRUG

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

Interventions

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Ortho Tri-Cyclen LO

Tablets, oral, OTC Lo 1 tab/daily (no dosage units), once daily, 28 days.

Intervention Type DRUG

Ortho Cyclen

Tablet, oral, Ortho Cyclen 1 tab/daily (no dosage units), once daily, 28 days.

Intervention Type DRUG

Ortho Cyclen + Efavirenz

Tablet, oral, OC + EFV 600 mg, once daily, 14 days.

Intervention Type DRUG

Ortho Cyclen

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

Intervention Type DRUG

Other Intervention Names

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Sustiva

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes