Back to resultsThe Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
Primary Purpose
Migraine, Migraine;Menstrual, Contraception
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Topiramate
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility 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
- 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.
Sites / Locations
- University of Colorado Denver
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ENG Implant Users
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03335163
First Posted
November 3, 2017
Last Updated
July 11, 2022
Sponsor
University of Colorado, Denver
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT03335163
Brief Title
The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
Official Title
The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
April 22, 2021 (Actual)
Study Completion Date
April 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum Etonogestrel (ENG) levels in contraceptive implant users.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Migraine;Menstrual, Contraception
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum ENG levels in contraceptive implant users
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ENG Implant Users
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Topiramate
Intervention Description
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
Primary Outcome Measure Information:
Title
Serum Etonogestrel Concentrations
Description
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.
Time Frame
Enrollment (Baseline), 4 weeks (Visit 2), 5 weeks (Visit 3), 6 weeks (Visit 4)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants must have an ENG implant contraception method in place prior to entry into the study.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Teal, MD
Organizational Affiliation
University of Colorado School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35594123
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
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