Pharmacokinetics and Pharmacodynamics of the Etonogestrel Contraceptive Implant When Co-administered With Efavirenz

• Status: Terminated
• Trial end date: 2018-04-04
• Target enrollment: 0
• Participant gender: Female

Summary

This study evaluates whether there is an interaction between etonogestrel, the progestin hormone released by the contraceptive implant Nexplanon, and efavirenz, a common medication used to treat HIV. The endpoints measured in this study will help determine if such an interaction leads to decreased contraceptive efficacy of the contraceptive implant.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: American College of Obstetricians and Gynecologists; The Campbell Foundation
• Treatments: Contraceptive Agents; Efavirenz; Etonogestrel

Criteria

Inclusion Criteria:

• Healthy women aged 18-40 years who have a Nexplanon®/Implanon® in place that is palpable on exam, had the device placed between 12 and 24 months prior to enrollment, and can provide documentation of when the implant was placed

• Able to speak and read English

• Documented HIV-negative status within 30 days of enrollment

• BMI between 18.5 and 24.9 kg/m2

• Willingness to take a two-week course of efavirenz

• Willingness to comply with study visit schedule (as described below), including blood sampling, transvaginal ultrasounds, and cervical mucus assessment

• Negative urine human chorionic gonadotropin pregnancy test at study entry

• Normal laboratory values within 30 days of study entry, as specified below:

• White blood cell count ≥ 4500 and ≤ 11000 cells/mm3

• Platelet count ≥ 100,000 platelets/mm3

• Hemoglobin ≥ 8.0 g/dL

• International normalized ratio (INR) ≤ 1.8

• Aspartate transaminase (SGOT) and alanine aminotransferase (SGPT) ≤ 3 times the upper limit of normal (ULN) (upper limit of normal)

• Creatinine ≤ 1.5 x ULN

• Serum amylase ≤ 1.5 x ULN

• Total bilirubin ≤ 2.0 x ULN

• Agree to use an additional reliable method of contraception while participating in the study. Acceptable methods include:

• Abstinence

• Condoms (male or female) with or without spermicide

• Pre-existing sterilization of subject or her male partner

• Willingness to abstain from alcohol consumption during the study period

• Willingness to abstain from any grapefruit product or supplement for the duration of the study.

Exclusion Criteria:

• Breastfeeding

• Hypersensitivity to efavirenz

• History of seizure disorder

• Initiated, discontinued, or changed doses of drugs that are cytochrome P450 isoenzyme 3A4 (CYP3A4) inducers or inhibitors within 30 days of study entry.