The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 1

Conditions: Contraception; Migraine; Migraine;Menstrual

Treatments: Drug: Topiramate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03335163

17-1047

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

48 participants in 1 patient group

ENG Implant Users

Experimental group

Description:

Healthy women using an ENG implant for at least 12 months and no greater than 36 months will be administered a 6 week titration schedule of topiramate to a max dose of 200mg bid by the final week.

Treatment:

Drug: Topiramate