Drug Interaction - Oral Contraceptive

Study Overview
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Ortho Tri-Cyclen LO
* Drug: Ortho Cyclen
* Drug: Ortho Cyclen + Efavirenz
* Drug: Ortho Cyclen


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Ortho Tri-Cyclen LO<br>* Tablets, oral, OTC Lo 1 tab/daily (no dosage units), once daily, 28 days.<br>|
| Active Comparator: B<br> | Drug: Ortho Cyclen<br>* Tablet, oral, Ortho Cyclen 1 tab/daily (no dosage units), once daily, 28 days.<br>|
| Active Comparator: C<br> | Drug: Ortho Cyclen + Efavirenz<br>* Tablet, oral, OC + EFV 600 mg, once daily, 14 days.<br>* Other names: Sustiva;|
| Active Comparator: D<br> | Drug: Ortho Cyclen<br>* Tablet, oral, OC 1 tab daily (no dosage units), once daily, 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect coadministration of efavirenz 600 mg on the pharmacokinetics of ethinyl estradiol and the metabolite of norgestimate |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV