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The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users

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ClinicalTrials.gov Identifier: NCT03335163
Recruitment Status : Not yet recruiting
First Posted : November 7, 2017
Last Update Posted : December 25, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
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
Anticipated Study Start Date : January 15, 2018
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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



Outcome Measures

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.


Eligibility Criteria

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
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

    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.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT03335163


Contacts
Contact: Becca Seale 303-724-2013 rebecca.seale@ucdenver.edu
Contact: Lisa Powers 303-724-5284 lisa.powers@ucdenver.edu

Sponsors and Collaborators
University of Colorado, Denver
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Stephanie Teal, MD University of Colorado School of Medicine
More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03335163     History of Changes
Other Study ID Numbers: 17-1047
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: December 25, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Contraceptive Agents
Etonogestrel
Topiramate
Reproductive Control Agents
Physiological Effects of Drugs
Anticonvulsants
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents
Contraceptive Agents, Female