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

NCT03307863 | Suspended Phase 4

• 1 other identifier: 2.140.103
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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

Keywords

etonogestrel implant; anti-epileptic drugs; pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• Area under the plasma concentration versus time curve (AUC) of ENG in women with epilepsy (WWE) using carbamazepine

  Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for area under the curve evaluation of ENG (AUC, 0-24 weeks). The plasma ENG AUC will be compared to that of women without epilepsy and without carbamazepine use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.

  Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement

• Plasma maximum concentration (Cmax) of ENG in women with epilepsy (WWE) using carbamazepine

  Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of plasma Cmax of ENG. The plasma ENG Cmax will be compared to that of women without epilepsy and without carbamazepine use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.

  Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement

• Plasma minimum concentration (Cmin) of ENG in women with epilepsy (WWE) using carbamazepine

  Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of plasma Cmin of ENG. The plasma ENG Cmin will be compared to that of women without epilepsy and without carbamazepine use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.

  Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement

• Time to maximum concentration (Tmax) of ENG in women with epilepsy (WWE) using carbamazepine

  Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of Tmax of ENG. The Tmax of ENG will be compared to that of women without epilepsy and without carbamazepine use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.

  Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement

Secondary Outcomes (13)

• Bleeding pattern associated with etonogestrel implant use

  Daily for 24 weeks

• Area under the plasma concentration versus time curve (AUC) of ENG in women with epilepsy (WWE) using topiramate

  Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement

• Plasma maximum concentration (Cmax) of ENG in women with epilepsy (WWE) using topiramate

  Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement

• Plasma minimum concentration (Cmin) of ENG in women with epilepsy (WWE) using topiramate

  Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement

• Time to maximum concentration (Tmax) of ENG in women with epilepsy (WWE) using topiramate

  Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement

Other Outcomes (2)

• Acceptability

  At 24 weeks of implant placement

• Satisfaction

  At 24 weeks of implant placement

Study Arms (3)

Carbamazepine-Implant

EXPERIMENTAL

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

Drug: Carbamazepine-Implant

Topiramate-Implant

EXPERIMENTAL

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

Drug: Topiramate-Implant

Implant

ACTIVE COMPARATOR

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

Drug: Implant

Interventions

Carbamazepine-Implant DRUG

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

Carbamazepine-Implant

Topiramate-Implant DRUG

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

Topiramate-Implant

Implant DRUG

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

Implant

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

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

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

MeSH Terms

Interventions

Drug Implants

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Carolina S Vieira, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, PhD

Model Details: It is a non-randomized clinical trial (controlled clinical trial)

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 12, 2017
• Study Start: November 1, 2017
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2028
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

BR (1)