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

NCT03953781 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2019-05-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Effect of valporate on Reproductive Functions in Newly Diagnosed Epileptic Males

DRUG

Effect of levetiracetam on epileptic males reproductive function

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2017-03-31
Completion
2017-06-30
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03953781 on ClinicalTrials.gov