Phase 1
Completed N=48
The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
Migraine · Migraine;Menstrual · Contraception
Source: ClinicalTrials.gov NCT03335163 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: Serum Etonogestrel Concentrations — 142.0; 126.0; 119.0; 105.0 pg/mL
Summary
A prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum Etonogestrel (ENG) levels in contraceptive implant users.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Etonogestrel Concentrations |
142.0; 126.0; 119.0; 105.0 | — |
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. Informational only — not medical advice.