Pharmacologic Strategies for the Etonogestrel Implant in HIV-Infected Women

Phase 2 Completed 72 enrolled Catherine Anne Chappell Infectious Disease Institute, Kampala, Uganda · collab University of Nebraska · collab

RandomizedParallel-groupSingle-blindTreatment

Summary

This study will evaluate the frequency of ovulation and cervical mucus quality of HIV-infected Ugandan women on efavirenz-based antiretroviral therapy using either a single etonogestrel implant or two etonogestrel implants for at least one year.

Timeline

Start: 2019-02-19
Primary completion: 2020-12-22
Completion: 2022-10-25

Outcome

Met primary endpoint

paper month 3: 11 [31%] vs 0 [0%]; month 6: 17 [49%] vs 0 [0%]; month 12: 19 [56%] vs 2 [6%], respectively; all P<.001 PMID 38458408 ↗

paper CONCLUSION: Over 48 weeks of combined use, placing 2 etonogestrel implants suppressed ovulation and increased plasma etonogestrel exposure when compared with 1 etonogestrel implant PMID 38458408 ↗

Publications

Chappell CA, Lamorde M, Nakalema S, Kyohairwe I, Byakika-Kibwika P, Meyn LA, Pham MM, Scarsi KK. A randomized trial of double vs single-dose etonogestrel implant to overcome the interaction with efavirenz-based antiretroviral therapy. Am J Obstet Gynecol. 2024 Aug;231(2):242.e1-242.e9. doi: 10.1016/j.ajog.2024.03.001. Epub 2024 Mar 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etonogestrel	Unknown	68 mg	Subcutaneous
Subject	Etonogestrel	Unknown	136 mg	Subcutaneous