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The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03335163
Recruitment Status : Active, not recruiting
First Posted : November 7, 2017
Last Update Posted : December 17, 2020
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Migraine Migraine;Menstrual Contraception Drug: Topiramate Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
Actual Study Start Date : March 15, 2018
Actual Primary Completion Date : November 23, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
Drug Information available for: Topiramate

Arm Intervention/treatment
Experimental: ENG Implant Users
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

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 Measures :
  1. Change in serum etonogestrel concentrations [ Time Frame: Enrollment, 4 weeks, 5 weeks, 6 weeks ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants must have an ENG implant contraception method in place prior to entry into the study.
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03335163

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United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Merck Sharp & Dohme Corp.
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Principal Investigator: Stephanie Teal, MD University of Colorado School of Medicine
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Responsible Party: University of Colorado, Denver Identifier: NCT03335163    
Other Study ID Numbers: 17-1047
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs