The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users

• Status: Active, not recruiting
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Contraceptive Agents; Etonogestrel; Topiramate

Criteria

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

1. Cytochrome P-450 enzyme inducers, inhibitors, or substrates, and

2. 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.