The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users

Phase 1

Completed

• Conditions: Contraception; Migraine;Menstrual; Migraine
• Interventions: Drug: Topiramate

• Registration Number: NCT03335163
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-07
• Study Start: 2018-03-15
• Primary Completion: 2021-04-22
• Study Completion: 2021-04-22
• Results First Submitted: 2022-03-17
• Status Verified: 2022-07
• Results First Submitted QC: 2022-07-11
• Last Update Submitted: 2022-07-11
• Results First Posted: 2022-07-13
• Last Update Posted: 2022-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ENG Implant Users	Topiramate	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.

Primary Outcome Measures

Name	Time	Method
Serum Etonogestrel Concentrations	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.

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States