The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users

Phase 1 Completed 48 enrolled University of Colorado, Denver Merck Sharp & Dohme LLC · collab

NaSingle-groupOpen-labelTreatment

Summary

A prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum Etonogestrel (ENG) levels in contraceptive implant users.

Timeline

Start: 2018-03-15
Primary completion: 2021-04-22
Completion: 2021-04-22

Outcome

Missed primary endpoint

paper The 95% CIs for mean percent change in serum etonogestrel concentrations from baseline were [-37.3%+16.9%], [-45.4%+5.2%], and [-66.8%+24.8%] at 3 weeks, 4 weeks, and 6 weeks, respectively. PMID 35594123 ↗

paper Though only a mild enzyme-inducing antiepileptic drug, concomitant topiramate use led to inferior serum etonogestrel concentrations among implant users PMID 35594123 ↗

Publications

Lazorwitz A, Pena M, Sheeder J, Teal S. Effect of Topiramate on Serum Etonogestrel Concentrations Among Contraceptive Implant Users. Obstet Gynecol. 2022 Apr 1;139(4):579-587. doi: 10.1097/AOG.0000000000004697. Epub 2022 Mar 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Topiramate	Small molecule	200 mg	Oral