ISRCTN12196183CompletedPhase 4
The effects of sodium valproate and oxcarbazepine on semen, sex hormones and sexual function in young male patients with epilepsy
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital0 sites77 target enrollmentStarted: April 26, 2020Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 77
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Sex
- Male
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
Investigators
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