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

• Status: Unknown status
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Sao Paulo
• Treatments: Anticonvulsants; Carbamazepine; Desogestrel; Etonogestrel; Topiramate

Criteria

Inclusion Criteria:

• women 18- 45 years old;

• with regular menstrual cycles;

• with BMI between 18 and 29.9 (kg/m2);

• who has selected the ENG implant as a contraceptive method;

• Using a stable antiepileptic drug regimen including carbamazepine or topiramate for ate least 3 months (only for women with epilepsy).

Exclusion Criteria:

• use of short-acting hormonal contraceptives in the month prior to enrollment;

• use of depomedroxyprogesterone acetate in the 6 months prior to enrollment;

• women with conditions classified as category 3 and/or 4 for etonogestrel implant use according to the World Health Organization Medical Eligibility Criteria for contraceptive use;

• drug or alcohol addiction;

• use of other drugs metabolized by CYP3A4 30 days prior to enrollment;

• non adherence to antiepileptic drug regimen (only for women with epilepsy);

• illiteracy