Status:
SUSPENDED
Effect of Anti-epileptic Drugs on Etonogestrel-releasing Implant Pharmacokinetics in Women With Epilepsy
Lead Sponsor:
University of Sao Paulo
Conditions:
Contraception
Drug Interactions
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2028
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT03307863
Start Date
November 1 2017
End Date
November 30 2028
Last Update
January 28 2025
Active Locations (1)
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1
Hospital das Clínicas de Ribeirão Preto da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, Brazil, 14049-900