NCT03307863

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

• Status: Suspended
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-11-01
• Primary completion: 2027-11-30
• Completion: 2028-11-30
• First posted: 2017-10-12
• Last updated: 2025-01-28

Locations

1 site across 1 country: Brazil