EpilepsyNCT03953781
Effect of Valproate Versus Levetiracetam Monotherapy on Reproductive Functions in Epileptic Males
An observational study of Epilepsy, run by Zagazig University.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Epilepsy
- What is being tested?
- Effect of valporate on Reproductive Functions in Newly Diagnosed Epileptic Males and Effect of levetiracetam on epileptic males reproductive function
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Child, Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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 .
About this study
Official title: Effect of Valproate Versus Levetiracetam Monotherapy on Reproductive Functions in Newly Diagnosed Epileptic Males
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Effect of valporate on Reproductive Functions in Newly Diagnosed Epileptic Males, Effect of levetiracetam on epileptic males reproductive function
- Keywords
- Epilepsy, antiepileptic drugs, males, reproduction
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of valporate on Reproductive Functions in Newly Diagnosed Epileptic MalesDrug
Also called Effect of depakin monotherapy on epileptic males reproductive function
Effect of levetiracetam on epileptic males reproductive functionDrug
Also called Effect of levepex on epileptic males reproductive function
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Effect of levetiracetam on epileptic males reproductive function |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of valproate on males' sex hormones in newly diagnosed epileptic males.
percent of valproate treated patients with change in luteinizing hormone and follicle stimulating hormones and prolactin serum level.
Measured: 8-weeks
the effect of valproate on sperm parameters in newly diagnosed epileptic males.
percent of valproate treated patients with change in semen analysis parameters.
Measured: 8-weeks
the effect of levetiracetam on males' sex hormones in newly diagnosed epileptic males.
percent of levetiracetam treated patients with change in luteinizing hormone and follicle stimulating hormones and prolactin serum level.
Measured: 8-weeks
the effect of levetiracetam on sperm parameters in newly diagnosed epileptic males.
percent of levetiracetam treated patients with change in semen analysis parameters.
Measured: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start1 Jun 2016
- Primary completion31 Mar 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, rania sanad, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953781
- Sponsor's protocol ID
- ZU-IRB#4731\ 24-1-2018
- Status last verified
- May 2019
- First submitted
- 17 Apr 2019
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: after publishing the manuscript in the Egyptian journal of neurology, psychiatry and neurosurgery
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Valproate Versus Levetiracetam Monotherapy on Reproductive Functions in Newly Diagnosed Epileptic Males
- ClinicalTrials.gov ID
- NCT03953781
- Acronym / sponsor ID
- ZU-IRB#4731\ 24-1-2018
- Conditions
- Epilepsy
- Keywords
- Epilepsy, antiepileptic drugs, males, reproduction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 17 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Drug: Effect of valporate on Reproductive Functions in Newly Diagnosed Epileptic Males25 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 2 | – | Drug: Effect of levetiracetam on epileptic males reproductive function25 participants were treated by levetiracetam (LEV) with the same regimens of valproate as a monotherapy, with ages ranged from 20-45 years. |
Who may qualify
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effect of valporate on Reproductive Functions in Newly Diagnosed Epileptic MalesAlso: Effect of depakin monotherapy on epileptic males reproductive function | Drug | group 1 |
| Effect of levetiracetam on epileptic males reproductive functionAlso: Effect of levepex on epileptic males reproductive function | Drug | group 2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Individual participant dataSharing planned: Yes. after publishing the manuscript in the Egyptian journal of neurology, psychiatry and neurosurgery
Related trials for Epilepsy
Not yet recruiting
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Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Zagazig University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effect of valproate on males' sex hormones in newly diagnosed epileptic males. (time frame: 8-weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2019.