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

U

University of Sao Paulo

Status and phase

Unknown
Phase 4

Conditions

Contraception
Drug Interactions

Treatments

Drug: Carbamazepine-Implant
Drug: Implant
Drug: Topiramate-Implant

Study type

Interventional

Funder types

Other

Identifiers

NCT03307863
2.140.103

Details and patient eligibility

About

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.

Enrollment

69 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

69 participants in 3 patient groups

Carbamazepine-Implant
Experimental group
Description:
Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted
Treatment:
Drug: Carbamazepine-Implant
Topiramate-Implant
Experimental group
Description:
Women with epilepsy using topiramate for at least 3 months will have an etonogestrel-releasing implant inserted
Treatment:
Drug: Topiramate-Implant
Implant
Active Comparator group
Description:
Women without epilepsy and not using an anti-epileptic drug will have an etonogestrel-releasing implant inserted
Treatment:
Drug: Implant

Trial contacts and locations

0

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Central trial contact

Carolina S Vieira, MD; Leticia S Ferreira, MD

Data sourced from clinicaltrials.gov

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