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

NCT ID: NCT03307863

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE4
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2028-11-30

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 topiramate) on the pharmacokinetic (PK) parameters of an ENG-releasing implant in women with epilepsy.

Conditions

Contraception; Drug Interactions

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Carbamazepine-Implant

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

Group Type: EXPERIMENTAL

Carbamazepine-Implant

Intervention Type: DRUG

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

Topiramate-Implant

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

Group Type: EXPERIMENTAL

Topiramate-Implant

Intervention Type: DRUG

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

Implant

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

Group Type: ACTIVE_COMPARATOR

Implant

Intervention Type: DRUG

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

Interventions

Carbamazepine-Implant

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

Intervention Type: DRUG

Topiramate-Implant

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

Intervention Type: DRUG

Implant

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Carolina Sales Vieira

Associate Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolina S Vieira, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Hospital das Clínicas de Ribeirão Preto da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

Other Identifiers

2.140.103

Identifier Type: -

Identifier Source: org_study_id