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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335163
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE November 3, 2017
First Posted Date  ICMJE November 7, 2017
Last Update Posted Date June 13, 2019
Actual Study Start Date  ICMJE March 15, 2018
Estimated Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
Official Title  ICMJE The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
Brief Summary A prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum Etonogestrel (ENG) levels in contraceptive implant users.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Migraine
  • Migraine;Menstrual
  • Contraception
Intervention  ICMJE 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

Study Arms  ICMJE 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.
Intervention: Drug: Topiramate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 3, 2017)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
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.
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Becca Seale 303-724-2013 rebecca.seale@ucdenver.edu
Contact: Lisa Powers 303-724-5284 lisa.powers@ucdenver.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03335163
Other Study ID Numbers  ICMJE 17-1047
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Stephanie Teal, MD University of Colorado School of Medicine
PRS Account University of Colorado, Denver
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP