Phase 1
N=48
The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
Migraine · Migraine;Menstrual · Contraception
Bottom Line
View on ClinicalTrials.gov: NCT03335163 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Serum Etonogestrel Concentrations — 142.0; 126.0; 119.0; 105.0 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Topiramate (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Etonogestrel Concentrations |
142.0; 126.0; 119.0; 105.0 | — |
Summary
A prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum Etonogestrel (ENG) levels in contraceptive implant users.
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.
Data sourced from ClinicalTrials.gov (NCT03335163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.