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Trial record 45 of 89 for:    CARBAMAZEPINE AND Psychotropic

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 : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Carolina Sales Vieira, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Contraception Drug Interactions Drug: Carbamazepine-Implant Drug: Topiramate-Implant Drug: Implant Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
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
Official Title: Effect of Anti-epileptic Drugs on Etonogestrel-releasing Implant Pharmacokinetics in Women With Epilepsy
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: Carbamazepine-Implant
Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted
Drug: Carbamazepine-Implant
Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted

Experimental: Topiramate-Implant
Women with epilepsy using topiramate 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

Active Comparator: Implant
Women without epilepsy and not using an anti-epileptic drug 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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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


Other Outcome Measures:
  1. Acceptability [ Time Frame: At 24 weeks of implant placement ]
    A questionnaire will be used to measure acceptability to etonogestrel implant by WWE

  2. Satisfaction [ Time Frame: At 24 weeks of implant placement ]
    A questionnaire will be applied to measure satisfaction of WWE with etonogestrel implant



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307863


Contacts
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Contact: Carolina S Vieira, MD +5536022818 carol.sales@usp.br
Contact: Leticia S Ferreira, MD +553491924258 lelezinhasanchez1@yahoo.com.br

Locations
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Brazil
Hospital das Clínicas de Ribeirão Preto da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo Recruiting
Ribeirão Preto, Sao Paulo, Brazil, 14049-900
Contact: Carolina S Vieira, MD    +551636022818    carol.sales@usp.br   
Contact: Leticia S Ferreira, MD    +553491924258    lelezinhasanchez1@yahoo.com.br   
Principal Investigator: Carolina S Vieira, MD         
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Carolina S Vieira, MD University of Sao Paulo

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Responsible Party: Carolina Sales Vieira, Associate Professor, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03307863     History of Changes
Other Study ID Numbers: 2.140.103
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carolina Sales Vieira, University of Sao Paulo:
etonogestrel implant
anti-epileptic drugs
pharmacokinetics
Additional relevant MeSH terms:
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Carbamazepine
Psychotropic Drugs
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Etonogestrel
Desogestrel
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Progestins