<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03307863</url>
  </required_header>
  <id_info>
    <org_study_id>2.140.103</org_study_id>
    <nct_id>NCT03307863</nct_id>
  </id_info>
  <brief_title>Effect of Anti-epileptic Drugs on Etonogestrel-releasing Implant Pharmacokinetics in Women With Epilepsy</brief_title>
  <official_title>Effect of Anti-epileptic Drugs on Etonogestrel-releasing Implant Pharmacokinetics in Women With Epilepsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Data on the interaction between the etonogestrel (ENG) implant and antiepileptic drug (AED)&#xD;
      regimen are scarce. We will evaluated the effect of 2 AED regimens (1 including carbamazepine&#xD;
      and the other topiramate) on the pharmacokinetic (PK) parameters of an ENG-releasing implant&#xD;
      in women with epilepsy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>It is a non-randomized clinical trial (controlled clinical trial)</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) of ENG in women with epilepsy (WWE) using carbamazepine</measure>
    <time_frame>Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma maximum concentration (Cmax) of ENG in women with epilepsy (WWE) using carbamazepine</measure>
    <time_frame>Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma minimum concentration (Cmin) of ENG in women with epilepsy (WWE) using carbamazepine</measure>
    <time_frame>Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to maximum concentration (Tmax) of ENG in women with epilepsy (WWE) using carbamazepine</measure>
    <time_frame>Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bleeding pattern associated with etonogestrel implant use</measure>
    <time_frame>Daily for 24 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) of ENG in women with epilepsy (WWE) using topiramate</measure>
    <time_frame>Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma maximum concentration (Cmax) of ENG in women with epilepsy (WWE) using topiramate</measure>
    <time_frame>Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma minimum concentration (Cmin) of ENG in women with epilepsy (WWE) using topiramate</measure>
    <time_frame>Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum concentration (Tmax) of ENG in women with epilepsy (WWE) using topiramate</measure>
    <time_frame>Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement</measure>
    <time_frame>Prior to implant placement and at 24 weeks of implant use</time_frame>
    <description>Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate AUC (0-8 hours) of carbamazepine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma maximum concentration (Cmax) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement</measure>
    <time_frame>Prior to implant placement and at 24 weeks of implant use</time_frame>
    <description>Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmax of carbamazepine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma minimum concentration (Cmin) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement</measure>
    <time_frame>Prior to implant placement and at 24 weeks of implant use</time_frame>
    <description>Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmin of carbamazepine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum concentration (Tmax) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement</measure>
    <time_frame>Prior to implant placement and at 24 weeks of implant use</time_frame>
    <description>Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Tmax of carbamazepine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) of topiramate in women with epilepsy (WWE) before and after ENG implant placement</measure>
    <time_frame>Prior to implant placement and at 24 weeks of implant use</time_frame>
    <description>Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate AUC (0-8 hours) of topiramate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma maximum concentration (Cmax) of topiramate in women with epilepsy (WWE)</measure>
    <time_frame>Prior to implant placement and at 24 weeks of implant use</time_frame>
    <description>Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmax of topiramate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma minimum concentration (Cmin) of topiramate in women with epilepsy (WWE) before and after ENG implant placement</measure>
    <time_frame>Prior to implant placement and at 24 weeks of implant use</time_frame>
    <description>Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmin of topiramate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum concentration (Tmax) of topiramate in women with epilepsy (WWE) before and after ENG implant placement</measure>
    <time_frame>Prior to implant placement and at 24 weeks of implant use</time_frame>
    <description>Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Tmax of topiramate</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Acceptability</measure>
    <time_frame>At 24 weeks of implant placement</time_frame>
    <description>A questionnaire will be used to measure acceptability to etonogestrel implant by WWE</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction</measure>
    <time_frame>At 24 weeks of implant placement</time_frame>
    <description>A questionnaire will be applied to measure satisfaction of WWE with etonogestrel implant</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">69</enrollment>
  <condition>Contraception</condition>
  <condition>Drug Interactions</condition>
  <arm_group>
    <arm_group_label>Carbamazepine-Implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Topiramate-Implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women with epilepsy using topiramate for at least 3 months will have an etonogestrel-releasing implant inserted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Implant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women without epilepsy and not using an anti-epileptic drug will have an etonogestrel-releasing implant inserted</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carbamazepine-Implant</intervention_name>
    <description>Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted</description>
    <arm_group_label>Carbamazepine-Implant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topiramate-Implant</intervention_name>
    <description>Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted</description>
    <arm_group_label>Topiramate-Implant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Implant</intervention_name>
    <description>Women without epilepsy and not using an anti-epileptic drug will have an etonogestrel-releasing implant inserted</description>
    <arm_group_label>Implant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women 18- 45 years old;&#xD;
&#xD;
          -  with regular menstrual cycles;&#xD;
&#xD;
          -  with BMI between 18 and 29.9 (kg/m2);&#xD;
&#xD;
          -  who has selected the ENG implant as a contraceptive method;&#xD;
&#xD;
          -  Using a stable antiepileptic drug regimen including carbamazepine or topiramate for&#xD;
             ate least 3 months (only for women with epilepsy).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  use of short-acting hormonal contraceptives in the month prior to enrollment;&#xD;
&#xD;
          -  use of depomedroxyprogesterone acetate in the 6 months prior to enrollment;&#xD;
&#xD;
          -  women with conditions classified as category 3 and/or 4 for etonogestrel implant use&#xD;
             according to the World Health Organization Medical Eligibility Criteria for&#xD;
             contraceptive use;&#xD;
&#xD;
          -  drug or alcohol addiction;&#xD;
&#xD;
          -  use of other drugs metabolized by CYP3A4 30 days prior to enrollment;&#xD;
&#xD;
          -  non adherence to antiepileptic drug regimen (only for women with epilepsy);&#xD;
&#xD;
          -  illiteracy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carolina S Vieira, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carolina S Vieira, MD</last_name>
    <phone>+5536022818</phone>
    <email>carol.sales@usp.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Leticia S Ferreira, MD</last_name>
    <phone>+553491924258</phone>
    <email>lelezinhasanchez1@yahoo.com.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital das Clínicas de Ribeirão Preto da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo</name>
      <address>
        <city>Ribeirão Preto</city>
        <state>Sao Paulo</state>
        <zip>14049-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carolina S Vieira, MD</last_name>
      <phone>+551636022818</phone>
      <email>carol.sales@usp.br</email>
    </contact>
    <contact_backup>
      <last_name>Leticia S Ferreira, MD</last_name>
      <phone>+553491924258</phone>
      <email>lelezinhasanchez1@yahoo.com.br</email>
    </contact_backup>
    <investigator>
      <last_name>Carolina S Vieira, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>August 3, 2019</last_update_submitted>
  <last_update_submitted_qc>August 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Carolina Sales Vieira</investigator_full_name>
    <investigator_title>Associate Professor, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>etonogestrel implant</keyword>
  <keyword>anti-epileptic drugs</keyword>
  <keyword>pharmacokinetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Topiramate</mesh_term>
    <mesh_term>Carbamazepine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03307863
org study id: 2.140.103
nct id: NCT03307863
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: It is a non-randomized clinical trial (controlled clinical trial)
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Area under the plasma concentration versus time curve (AUC) of ENG in women with epilepsy (WWE) using carbamazepine
time frame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
description: 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.
measure: Plasma maximum concentration (Cmax) of ENG in women with epilepsy (WWE) using carbamazepine
time frame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
description: 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.
measure: Plasma minimum concentration (Cmin) of ENG in women with epilepsy (WWE) using carbamazepine
time frame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
description: 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.
measure: Time to maximum concentration (Tmax) of ENG in women with epilepsy (WWE) using carbamazepine
time frame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
description: 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.
measure: Bleeding pattern associated with etonogestrel implant use
time frame: Daily for 24 weeks
description: 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
measure: Area under the plasma concentration versus time curve (AUC) of ENG in women with epilepsy (WWE) using topiramate
time frame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
description: 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.
measure: Plasma maximum concentration (Cmax) of ENG in women with epilepsy (WWE) using topiramate
time frame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
description: 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.
measure: Plasma minimum concentration (Cmin) of ENG in women with epilepsy (WWE) using topiramate
time frame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
description: 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.
measure: Time to maximum concentration (Tmax) of ENG in women with epilepsy (WWE) using topiramate
time frame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
description: 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.
measure: Area under the plasma concentration versus time curve (AUC) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement
time frame: Prior to implant placement and at 24 weeks of implant use
description: Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate AUC (0-8 hours) of carbamazepine
measure: Plasma maximum concentration (Cmax) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement
time frame: Prior to implant placement and at 24 weeks of implant use
description: Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmax of carbamazepine
measure: Plasma minimum concentration (Cmin) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement
time frame: Prior to implant placement and at 24 weeks of implant use
description: Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmin of carbamazepine
measure: Time to maximum concentration (Tmax) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement
time frame: Prior to implant placement and at 24 weeks of implant use
description: Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Tmax of carbamazepine
measure: Area under the plasma concentration versus time curve (AUC) of topiramate in women with epilepsy (WWE) before and after ENG implant placement
time frame: Prior to implant placement and at 24 weeks of implant use
description: Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate AUC (0-8 hours) of topiramate
measure: Plasma maximum concentration (Cmax) of topiramate in women with epilepsy (WWE)
time frame: Prior to implant placement and at 24 weeks of implant use
description: Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmax of topiramate
measure: Plasma minimum concentration (Cmin) of topiramate in women with epilepsy (WWE) before and after ENG implant placement
time frame: Prior to implant placement and at 24 weeks of implant use
description: Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmin of topiramate
measure: Time to maximum concentration (Tmax) of topiramate in women with epilepsy (WWE) before and after ENG implant placement
time frame: Prior to implant placement and at 24 weeks of implant use
description: Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Tmax of topiramate
measure: Acceptability
time frame: At 24 weeks of implant placement
description: A questionnaire will be used to measure acceptability to etonogestrel implant by WWE
measure: Satisfaction
time frame: At 24 weeks of implant placement
description: A questionnaire will be applied to measure satisfaction of WWE with etonogestrel implant
arm group label: Carbamazepine-Implant
arm group type: Experimental
description: Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted
arm group label: Topiramate-Implant
arm group type: Experimental
description: Women with epilepsy using topiramate for at least 3 months will have an etonogestrel-releasing implant inserted
arm group label: Implant
arm group type: Active Comparator
description: Women without epilepsy and not using an anti-epileptic drug will have an etonogestrel-releasing implant inserted
intervention type: Drug
intervention name: Carbamazepine-Implant
description: Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted
arm group label: Carbamazepine-Implant
intervention type: Drug
intervention name: Topiramate-Implant
description: Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted
arm group label: Topiramate-Implant
intervention type: Drug
intervention name: Implant
description: Women without epilepsy and not using an anti-epileptic drug will have an etonogestrel-releasing implant inserted
arm group label: Implant
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carolina S Vieira, MD
role: Principal Investigator
affiliation: University of Sao Paulo
last name: Carolina S Vieira, MD
phone: +5536022818
email: carol.sales@usp.br
last name: Leticia S Ferreira, MD
phone: +553491924258
email: lelezinhasanchez1@yahoo.com.br
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Carolina Sales Vieira
investigator title: Associate Professor, MD, PhD
mesh term: Epilepsy
mesh term: Topiramate
mesh term: Carbamazepine