The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users

NCT03335163 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 17-1047
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Migraine; Migraine;Menstrual; Contraception

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

ENG Implant Users

EXPERIMENTAL

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.

Drug: Topiramate

Interventions

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

ENG Implant Users

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Participants must have an ENG implant contraception method in place prior to entry into the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Lazorwitz A, Pena M, Sheeder J, Teal S. Effect of Topiramate on Serum Etonogestrel Concentrations Among Contraceptive Implant Users. Obstet Gynecol. 2022 Apr 1;139(4):579-587. doi: 10.1097/AOG.0000000000004697. Epub 2022 Mar 10.

  PMID: 35594123 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Results Point of Contact

• Title: Dr. Aaron Lazorwitz
• Organization: University of Colorado Anschutz Medical Campus

aaron.lazorwitz@cuanschutz.edu

3037242019

Study Officials

• Stephanie Teal, MD

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum ENG levels in contraceptive implant users

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 7, 2017
• Study Start: March 15, 2018
• Primary Completion: April 22, 2021
• Study Completion: April 22, 2021
• Last Updated: July 13, 2022
• Results First Posted: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)