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

University of Sao Paulo69 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Contraception Drug Interactions

Interventions

Carbamazepine-ImplantDRUG

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

Topiramate-ImplantDRUG

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

ImplantDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Ribeirão Preto, São Paulo, Brazil

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

Data from ClinicalTrials.gov

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Secondary Outcomes

Bleeding pattern associated with etonogestrel implant use

Bleeding pattern (frequency, duration and number of bleeding/spotting days) associated with etonogestrel implant use will be evaluated in WWE using carbamazepine or topiramate and in women without epilepsy and without antiepileptic drug use

Time frame: Daily for 24 weeks

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

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 topiramate use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.

Time frame: 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

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 topiramate use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.

Time frame: 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

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 topiramate use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.

Time frame: 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

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 topiramate use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.

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

Area under the plasma concentration versus time curve (AUC) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement

Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate AUC (0-8 hours) of carbamazepine

Time frame: Prior to implant placement and at 24 weeks of implant use

Plasma maximum concentration (Cmax) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement

Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmax of carbamazepine

Time frame: Prior to implant placement and at 24 weeks of implant use

Plasma minimum concentration (Cmin) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement

Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmin of carbamazepine

Time frame: Prior to implant placement and at 24 weeks of implant use

Time to maximum concentration (Tmax) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement

Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Tmax of carbamazepine

Time frame: Prior to implant placement and at 24 weeks of implant use

Area under the plasma concentration versus time curve (AUC) of topiramate in women with epilepsy (WWE) before and after ENG implant placement

Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate AUC (0-8 hours) of topiramate

Time frame: Prior to implant placement and at 24 weeks of implant use

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

Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmax of topiramate

Time frame: Prior to implant placement and at 24 weeks of implant use

Plasma minimum concentration (Cmin) of topiramate in women with epilepsy (WWE) before and after ENG implant placement

Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmin of topiramate

Time frame: Prior to implant placement and at 24 weeks of implant use

Time to maximum concentration (Tmax) of topiramate in women with epilepsy (WWE) before and after ENG implant placement

Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Tmax of topiramate

Time frame: Prior to implant placement and at 24 weeks of implant use