The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users

Migraine Clinical Trial

Official title:

The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03335163
• Other study ID #: 17-1047
• Status: Completed
• Phase: Phase 1
• Start date: March 15, 2018
• Est. completion date: April 22, 2021

Study information

• Verified date: July 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 22, 2021
• Est. primary completion date: April 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraception
• Migraine
• Migraine Disorders
• Migraine;Menstrual

Intervention

Drug:
• Topiramate
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

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Etonogestrel Concentrations	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.	Enrollment (Baseline), 4 weeks (Visit 2), 5 weeks (Visit 3), 6 weeks (Visit 4)