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

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ClinicalTrials.gov Identifier: NCT03307863
Recruitment Status : Recruiting
First Posted : October 12, 2017
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Carolina Sales Vieira, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE September 27, 2017
First Posted Date  ICMJE October 12, 2017
Last Update Posted Date October 12, 2017
Estimated Study Start Date  ICMJE October 2017
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2017)
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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 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 ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2017)
  • Bleeding pattern associated with etonogestrel implant use [ Time Frame: Daily for 24 weeks ]
    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
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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 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 ]
    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.
  • 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 ]
    Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate AUC (0-8 hours) of carbamazepine
  • 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 ]
    Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmax of carbamazepine
  • 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 ]
    Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmin of carbamazepine
  • 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 ]
    Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Tmax of carbamazepine
  • 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 ]
    Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate AUC (0-8 hours) of topiramate
  • Plasma maximum concentration (Cmax) of topiramate in women with epilepsy (WWE) [ Time Frame: Prior to implant placement and at 24 weeks of implant use ]
    Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmax of topiramate
  • 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 ]
    Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmin of topiramate
  • 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 ]
    Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Tmax of topiramate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 10, 2017)
  • Acceptability [ Time Frame: At 24 weeks of implant placement ]
    A questionnaire will be used to measure acceptability to etonogestrel implant by WWE
  • Satisfaction [ Time Frame: At 24 weeks of implant placement ]
    A questionnaire will be applied to measure satisfaction of WWE with etonogestrel implant
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Anti-epileptic Drugs on Etonogestrel-releasing Implant Pharmacokinetics in Women With Epilepsy
Official Title  ICMJE Effect of Anti-epileptic Drugs on Etonogestrel-releasing Implant Pharmacokinetics in Women With Epilepsy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
It is a non-randomized clinical trial (controlled clinical trial)
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Contraception
  • Drug Interactions
Intervention  ICMJE
  • Drug: Carbamazepine-Implant
    Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted
  • Drug: Topiramate-Implant
    Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted
  • Drug: Implant
    Women without epilepsy and not using an anti-epileptic drug will have an etonogestrel-releasing implant inserted
Study Arms  ICMJE
  • Experimental: Carbamazepine-Implant
    Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted
    Intervention: Drug: Carbamazepine-Implant
  • Experimental: Topiramate-Implant
    Women with epilepsy using topiramate for at least 3 months will have an etonogestrel-releasing implant inserted
    Intervention: Drug: Topiramate-Implant
  • Active Comparator: Implant
    Women without epilepsy and not using an anti-epileptic drug will have an etonogestrel-releasing implant inserted
    Intervention: Drug: Implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 10, 2017)
69
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Carolina S Vieira, MD +5536022818 carol.sales@usp.br
Contact: Leticia S Ferreira, MD +553491924258 lelezinhasanchez1@yahoo.com.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03307863
Other Study ID Numbers  ICMJE 2.140.103
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carolina Sales Vieira, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carolina S Vieira, MD University of Sao Paulo
PRS Account University of Sao Paulo
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP