Pharmacokinetics and Pharmacodynamics of the Etonogestrel Contraceptive Implant When Co-administered With Efavirenz
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|ClinicalTrials.gov Identifier: NCT01980342|
Recruitment Status : Active, not recruiting
First Posted : November 8, 2013
Last Update Posted : November 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Drug Interaction||Drug: Efavirenz||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics and Pharmacodynamics of the Etonogestrel Contraceptive Implant When Co-administered With Efavirenz|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||August 2017|
Healthy, reproductive-age women using the etonogestrel contraceptive implant who will take a two-week course of efavirenz 400 mg orally each night.
Healthy women who are using Nexplanon will be asked to take a 2-week course of reduced-dose efavirenz (400 mg daily).
Other Name: Sustiva
- Serum concentration of etonogestrel before and after two weeks of efavirenz [ Time Frame: 6 weeks ]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.
- Serum efavirenz concentrations at the start and end of the 2-week dosing period [ Time Frame: 2 weeks ]We will assess serum efavirenz concentrations at the beginning and end of the 2-week dosing period. By comparing these concentrations to historical controls, we will determine whether taking efavirenz while using the etonogestrel implant alters the serum concentration of efavirenz.
- Serum hormone markers of ovulation [ Time Frame: 6 weeks ]We will test serial blood samples for levels of luteinizing hormone (LH), follicle stimulating hormone (FSH), estradiol, and progesterone to determine whether the etonogestrel implant is able to suppress ovulation during and after a course of efavirenz.
- Transvaginal ultrasound to assess for ovarian follicular development [ Time Frame: 6 weeks ]For the entire 6 week period of the study, participants will undergo twice-weekly transvaginal ultrasound to assess for the development of ovarian follicles. This direct assessment of follicular development will be combined with serum hormone concentrations to determine if efavirenz increases the incidence of ovulation in women using the etonogestrel implant for contraception.
- Cervical mucus quality [ Time Frame: 6 weeks ]Cervical mucus quality will be assessed twice weekly throughout the study period. The etonogestrel implant exerts a secondary contraceptive effect by causing cervical mucus to become thick and sticky, and therefore less permissive to the movement of sperm through the female genital tract. We will assess whether efavirenz causes a change in cervical mucus quality that would make sperm penetration more likely, and therefore indicate a reduction in the implant's contraceptive effect.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980342
|United States, Maryland|
|Johns Hopkins University Bayview Medical Center|
|Baltimore, Maryland, United States, 21224|