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A study of the effects of drugs used to treat epilepsy on semen, sex hormones and sexual function in young male patients with epilepsy

Phase 4
Completed
Conditions
Epilepsy
Nervous System Diseases
Registration Number
ISRCTN12196183
Lead Sponsor
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Male
Target Recruitment
77
Inclusion Criteria

1. Patients with simple partial seizures, complex partial seizures or secondarily generalized seizures
2. Healthy young male volunteers (control group)

Exclusion Criteria

1. Use of hormones, antidepressants, or drugs to improve sexual function
2. Liver and kidney dysfunction, thyroid disease, diabetes, infectious diseases, varicocele, cryptorchidism, history of testicular surgery, Klinefelter syndrome, or urinary system diseases
3. Long-term alcoholism, smoking, or exposure to toxic substances
4. Mental illness, intracranial occupying lesions, brain injury, or progressive degeneration of the nervous system
5. Inability to cooperate or refusal to participate in the study

Individual participation in the study was terminated if any of the following conditions were met:
1. Patients experienced adverse drug reactions after taking the medications and needed to discontinue the drug
2. Patients failed to achieve an ideal treatment effect (i.e., the reduction in the frequency of epileptic seizures is less than 75% after three months of treatment), and other AEDs needed to be substituted or added
3. Patients or volunteers took medications or suffered from diseases that might affect the results during the study
4. Participants withdrew from the study for personal reasons

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Quality of semen measured using lab test of semen sample at baseline and six months
Secondary Outcome Measures
NameTimeMethod
<br> 1. Sex hormones measured using lab test of blood sample at baseline and six months<br> 2. Sexual function measured using International Index of Erectile Function 5 (IIEF-5) at baseline and six months<br>
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