Clinical trial NCT03307863: Effect of Anti-epileptic Drugs on Etonogestrel-releasing Implant Pharmacokinetics in Women With Epilepsy
Official title: Effect of Anti-epileptic Drugs on Etonogestrel-releasing Implant Pharmacokinetics in Women With Epilepsy
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Contraception
Drug Interactions
Keywords: etonogestrel implant
anti-epileptic drugs
pharmacokinetics
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a non-randomized clinical trial (controlled clinical trial)
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of ENG in women with epilepsy (WWE) using carbamazepine
timeFrame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
measure: Plasma maximum concentration (Cmax) of ENG in women with epilepsy (WWE) using carbamazepine
timeFrame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
measure: Plasma minimum concentration (Cmin) of ENG in women with epilepsy (WWE) using carbamazepine
timeFrame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
measure: Time to maximum concentration (Tmax) of ENG in women with epilepsy (WWE) using carbamazepine
timeFrame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
Secondary outcomes:
measure: Bleeding pattern associated with etonogestrel implant use
timeFrame: Daily for 24 weeks
measure: Area under the plasma concentration versus time curve (AUC) of ENG in women with epilepsy (WWE) using topiramate
timeFrame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
measure: Plasma maximum concentration (Cmax) of ENG in women with epilepsy (WWE) using topiramate
timeFrame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
measure: Plasma minimum concentration (Cmin) of ENG in women with epilepsy (WWE) using topiramate
timeFrame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
measure: Time to maximum concentration (Tmax) of ENG in women with epilepsy (WWE) using topiramate
timeFrame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
measure: Area under the plasma concentration versus time curve (AUC) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement
timeFrame: Prior to implant placement and at 24 weeks of implant use
measure: Plasma maximum concentration (Cmax) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement
timeFrame: Prior to implant placement and at 24 weeks of implant use
measure: Plasma minimum concentration (Cmin) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement
timeFrame: Prior to implant placement and at 24 weeks of implant use
measure: Time to maximum concentration (Tmax) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement
timeFrame: Prior to implant placement and at 24 weeks of implant use
measure: Area under the plasma concentration versus time curve (AUC) of topiramate in women with epilepsy (WWE) before and after ENG implant placement
timeFrame: Prior to implant placement and at 24 weeks of implant use
measure: Plasma maximum concentration (Cmax) of topiramate in women with epilepsy (WWE)
timeFrame: Prior to implant placement and at 24 weeks of implant use
measure: Plasma minimum concentration (Cmin) of topiramate in women with epilepsy (WWE) before and after ENG implant placement
timeFrame: Prior to implant placement and at 24 weeks of implant use
measure: Time to maximum concentration (Tmax) of topiramate in women with epilepsy (WWE) before and after ENG implant placement
timeFrame: Prior to implant placement and at 24 weeks of implant use
Other outcomes:
measure: Acceptability
timeFrame: At 24 weeks of implant placement
measure: Satisfaction
timeFrame: At 24 weeks of implant placement
Locations:
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas de Ribeirão Preto da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Carolina S Vieira, MD
role: PRINCIPAL_INVESTIGATOR
References: