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

Stopped early · Phase 4

Conditions studied: Drug Interaction

In brief

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.

Key facts

Study ID

NCT01980342

Run by

Johns Hopkins University

People needed

1

Starts

2014-10-01

Expected to finish

2018-04-04

Last updated by the study team

2018-05-11

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins University Bayview Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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