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Effect of Valproate Versus Levetiracetam Monotherapy on Reproductive Functions in Epileptic Males

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ClinicalTrials.gov Identifier: NCT03953781
Recruitment Status : Completed
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
rania sanad, Zagazig University

Tracking Information
First Submitted Date April 17, 2019
First Posted Date May 17, 2019
Last Update Posted Date May 17, 2019
Actual Study Start Date June 1, 2016
Actual Primary Completion Date March 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 14, 2019)
  • the effect of valproate on males' sex hormones in newly diagnosed epileptic males. [ Time Frame: 8-weeks ]
    percent of valproate treated patients with change in luteinizing hormone and follicle stimulating hormones and prolactin serum level.
  • the effect of valproate on sperm parameters in newly diagnosed epileptic males. [ Time Frame: 8-weeks ]
    percent of valproate treated patients with change in semen analysis parameters.
  • the effect of levetiracetam on males' sex hormones in newly diagnosed epileptic males. [ Time Frame: 8-weeks ]
    percent of levetiracetam treated patients with change in luteinizing hormone and follicle stimulating hormones and prolactin serum level.
  • the effect of levetiracetam on sperm parameters in newly diagnosed epileptic males. [ Time Frame: 8-weeks ]
    percent of levetiracetam treated patients with change in semen analysis parameters.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Valproate Versus Levetiracetam Monotherapy on Reproductive Functions in Epileptic Males
Official Title Effect of Valproate Versus Levetiracetam Monotherapy on Reproductive Functions in Newly Diagnosed Epileptic Males
Brief Summary Background: Different antiepileptic drugs are responsible for reproductive dysfunction in male epileptic patients. The aim of this study is to evaluate the effect of valproate versus levetiracetam as a monotherapy on males' sex hormones and sperm parameters in newly diagnosed epilepsy. Methods: This comparative study included 50 newly diagnosed epileptic male participants from outpatient clinic of Neurology department of Zagazig University Hospitals. All participants were subjected to complete general and neurological examination, Doppler ultrasonography of the testis, pre and post treatment serum sex hormone assay and semen analysis. Post- treatment re- evaluation check point was determined if eight weeks have passed after the last seizures. This study included two groups, group I: 25 participants, were treated by valproate (VPA) as a monotherapy till became seizure free at the last 8-weeks before post treatment check-point, with ages ranged from 18-43 years. Group II: 25 participants were treated by levetiracetam (LEV) with the same regimens of valproate as a monotherapy, with ages ranged from 20-45 years.
Detailed Description

Background: Epilepsy is a chronic neurological disorder characterized by recurrent epileptic attacks and researches have reported that the relation between epilepsy and the reproductive dysfunction is not yet completely understood. Seizures are linked with sexual dysfunction as part of the disease pathophysiology in these patients. Through epileptic discharge, hypothalamus receives signals from hippocampus, amygdala and cerebral cortex. Hypothalamic-pituitary axis signaling changes is leading to sex hormones release including follicle stimulating hormones and luteinizing hormone changes.

However, the available antiepileptic drugs (AED) have not yet been proven to have negative impacts on sexual function. Evaluation of AED induced sexual dysfunction is complicated, less than clear, and is hard to find. Sex hormone levels can be changed due to AEDs which are the cause of sexual dysfunction and reproductive disorders Different antiepileptic drugs are responsible for reproductive dysfunction in male epileptic patients. The aim of this study is to evaluate the effect of valproate versus levetiracetam as a monotherapy on males' sex hormones and sperm parameters in newly diagnosed epilepsy. Methods: This comparative study included 50 newly diagnosed epileptic male participants from outpatient clinic of Neurology department of Zagazig University Hospitals. All participants were subjected to complete general and neurological examination, Doppler ultrasonography of the testis, pre and post treatment serum sex hormone assay and semen analysis. Post- treatment re- evaluation check point was determined if eight weeks have passed after the last seizures. This study included two groups, group I: 25 participants, were treated by valproate (VPA) as a monotherapy till became seizure free at the last 8-weeks before post treatment check-point, with ages ranged from 18-43 years. Group II: 25 participants were treated by levetiracetam (LEV) with the same regimens of valproate as a monotherapy, with ages ranged from 20-45 years.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study included 50 newly diagnosed epileptic males (clinically and electro physiologically ((EEG)) according to the International League against Epilepsy ((ILAE)) classification 2010)
Condition Epilepsy
Intervention
  • Drug: Effect of valporate on Reproductive Functions in Newly Diagnosed Epileptic Males
    Other Name: Effect of depakin monotherapy on epileptic males reproductive function
  • Drug: Effect of levetiracetam on epileptic males reproductive function
    Other Name: Effect of levepex on epileptic males reproductive function
Study Groups/Cohorts
  • group 1
    25 participants, were treated by valproate (VPA) as a monotherapy till became seizure free at the last 8-weeks before post treatment check-point, with ages ranged from 18-43 years
    Intervention: Drug: Effect of valporate on Reproductive Functions in Newly Diagnosed Epileptic Males
  • group 2
    25 participants were treated by levetiracetam (LEV) with the same regimens of valproate as a monotherapy, with ages ranged from 20-45 years.
    Intervention: Drug: Effect of levetiracetam on epileptic males reproductive function
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 Completed
Actual Enrollment
 (submitted: May 14, 2019)
50
Original Actual Enrollment Same as current
Actual Study Completion Date June 30, 2017
Actual Primary Completion Date March 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Ages between 18-45 years.
  • All participants had normal brain imaging (Brain CT or MRI).
  • All participants had normal thyroid functions and normal sex hormones assay.

Exclusion Criteria:

  • participants are currently receiving hormonal replacement therapy, or any drugs that may affect reproductive functions were excluded.
  • participants with significant or progressive medical illness.
  • participants with testicular atrophy, varicocele or infectious diseases .
Sex/Gender
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03953781
Other Study ID Numbers ZU-IRB#4731\ 24-1-2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: after publishing the manuscript in the Egyptian journal of neurology, psychiatry and neurosurgery
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: after publishing the manuscript in the Egyptian journal of neurology, psychiatry and neurosurgery
Access Criteria: after publishing the manuscript in the Egyptian journal of neurology, psychiatry and neurosurgery
URL: http://ejnpn.springeropen.com
Responsible Party rania sanad, Zagazig University
Study Sponsor Zagazig University
Collaborators Not Provided
Investigators Not Provided
PRS Account Zagazig University
Verification Date May 2019