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Effect of Anti-epileptic Drugs on Etonogestrel-releasing Implant Pharmacokinetics in Women With Epilepsy

NCT03307863 · Status: SUSPENDED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2025-01-28

No results posted yet for this study

Summary

Data on the interaction between the etonogestrel (ENG) implant and antiepileptic drug (AED) regimen are scarce. We will evaluated the effect of 2 AED regimens (1 including carbamazepine and the other topiramate) on the pharmacokinetic (PK) parameters of an ENG-releasing implant in women with epilepsy.

Conditions

  • Contraception
  • Drug Interactions

Interventions

DRUG

Carbamazepine-Implant

Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted

DRUG

Topiramate-Implant

Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted

DRUG

Implant

Women without epilepsy and not using an anti-epileptic drug will have an etonogestrel-releasing implant inserted

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Carolina S Vieira, MD · University of Sao Paulo

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2027-11-30
Completion
2028-11-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03307863 on ClinicalTrials.gov