NCT01980342

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2018

Completed
1 month until next milestone

Results Posted

Study results publicly available

May 11, 2018

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

3.5 years

First QC Date

November 4, 2013

Results QC Date

April 5, 2018

Last Update Submit

May 8, 2018

Conditions

Drug Interaction

Keywords

Long acting reversible contraceptionHIV

Outcome Measures

Primary Outcomes (1)

  • Serum Concentration of Etonogestrel Before and After Two Weeks of Efavirenz

    We will draw a baseline serum etonogestrel immediately prior to a participant starting the 2-week course of efavirenz. Serial blood samples will subsequently be drawn over the next 6 weeks to assess for changes in serum etonogestrel concentration. We will be looking to see if the serum etonogestrel concentration decreases below the level necessary for reliable ovulation suppression.

    6 weeks

Secondary Outcomes (4)

  • Serum Efavirenz Concentrations at the Start and End of the 2-week Dosing Period

    2 weeks

  • Serum Hormone Markers of Ovulation

    6 weeks

  • Transvaginal Ultrasound to Assess for Ovarian Follicular Development

    6 weeks

  • Cervical Mucus Quality

    6 weeks

Study Arms (1)

Efavirenz

EXPERIMENTAL

Healthy, reproductive-age women using the etonogestrel contraceptive implant who will take a two-week course of efavirenz 400 mg orally each night.

Drug: Efavirenz

Interventions

EfavirenzDRUG

Healthy women who are using Nexplanon will be asked to take a 2-week course of reduced-dose efavirenz (400 mg daily).

Also known as: Sustiva
Efavirenz

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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
  • +7 more criteria

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Interventions

efavirenz

Results Point of Contact

Title
Jenny Robinson, MD MP FACOG
Organization
Johns Hopkins University School of Medicine
mailto:jrobin87@jhmi.edu
4105500337

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2013

First Posted

November 8, 2013

Study Start

October 1, 2014

Primary Completion

April 4, 2018

Study Completion

April 4, 2018

Last Updated

May 11, 2018

Results First Posted

May 11, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)