At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 48 enrolled

Drug / intervention

Topiramatedrug

Likely dose

Topiramate 400mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03335163

NCT03335163Phase 1Completed

Compare CT.gov

The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users

University of Colorado, Denver·interventional·Posted Nov 7, 2017·Updated Jul 13, 2022

In Brief

A Phase 1 clinical trial evaluating Topiramate for Migraine and 2 related conditions. Completed, enrolled 48 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMigraine, Migraine;Menstrual, Contraception

CountriesUnited States

CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 1CompletedFinished

201820192020202120222023202420252026

First PostedNov 2017

Enrollment StartMar 2018

Primary CompletionApr 2021

TodayJul 2026

First PostedNov 7, 2017

Enrollment StartMar 15, 2018

Primary CompletionApr 22, 2021

TodayJul 2, 2026

Enrollment to primary: 3.1 yearsPosted 8.7 years ago

Interventions

Topiramatedrug

Topiramate - Participants will undergo a 6 week titrated regimen of oral topiramate to reach a maximum dose of 400mg per day: Week 1 - topiramate PO 25mg daily Week 2 - topiramate PO 25mg twice daily Week 3 - topiramate PO 50mg twice daily Week 4 - topiramate PO 100mg twice daily Week 5 - topiramate PO 150mg twice daily Week 6 - topiramate PO 200mg twice daily