The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users



Status:Recruiting
Conditions:Contraception, Contraception, Migraine Headaches
Therapuetic Areas:Neurology, Reproductive
Healthy:No
Age Range:18 - 45
Updated:4/17/2018
Start Date:March 15, 2018
End Date:July 31, 2019
Contact:Becca Seale
Email:rebecca.seale@ucdenver.edu
Phone:303-724-2013

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


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.
We found this trial at
1
site
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Phone: 303-724-2013
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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