The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users

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

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Contraception Headache Disorders Headache Disorders, Primary Migraine Disorders Migraine;Menstrual Nervous System Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy women, who have had an ENG implant for 12-36 months at the time of enrollment;
Will maintain their implant during the study without modifications.

Exclusion criteria

Women who are taking any medications or supplements known to be

Cytochrome P-450 enzyme inducers, inhibitors, or substrates, and
are not willing to abstain from any of these medications or supplements during the entire course of the study.
Women with liver disease (i.e. hepatitis, fatty liver disease), and
Women with abnormal liver or renal function, or
Women with abnormal electrolytes on their screening blood work.

Treatment and study plan

Topiramate

Drug

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

Primary outcomes

Serum Etonogestrel Concentrations

Time frame: Enrollment (Baseline), 4 weeks (Visit 2), 5 weeks (Visit 3), 6 weeks (Visit 4)

The investigators will collect serum from participants at enrollment and at each of the three study follow-up visits. All samples will be batched for analysis. Analysis will be performed using a liquid-chromatography mass-spectrometry validated assay for measurement of serum etonogestrel concentration.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

Merck Sharp & Dohme LLC

Registry information

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: Nov 7, 2017
Registry last updated: Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed