Erectile Dysfunction Clinical Trial
Official title:
Oral Administration of L-Arginine in Patients With Erectile Dysfunction
The purpose of the study is to determine whether the treatment with L-arginine leads to an improvement of erectile dysfunction in patients with erectile dysfunction.
Status | Completed |
Enrollment | 57 |
Est. completion date | November 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients age between 20 and 65 years, an ED for at least 6 months duration and written consent. - Each patient had to be informed about the study details in written and oral form before the beginning of the drug administration. - The hormonal status including dehydroepiandrosterone sulfate (DHEAS), Prolactin and Testosteron of each patient had to be within the normal range. - Exclusion Criteria: - Patients with primary erectile dysfunction, congenital anomalies, Diabetes mellitus, severe hepatic-and renal insufficiency, severe cardiovascular diseases, cerebrovascular accidents, uncontrolled hypertension, endocrine diseases, psychiatric disorders, and evidence of dementia were excluded. - Patients were excluded if they had pelvic fractures or prostatectomy and if they had undergone reconstructive or prosthetic surgery on the penis. - Increased levels of serum potassium, known hypersensitivity to the study medication or any ingredient of the drug. - Administration of PDE-5-Inhibitors (sildenafil, tadalafil, vardenafil or apomorphine) within four weeks prior to the administration of l-arginine or placebo led to exclusion. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Institute of Clinical Pharmacology, Hannover Medical School | Hannover | Lower Saxony |
Lead Sponsor | Collaborator |
---|---|
Hannover Medical School | Pharmacia |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | International Index of Erectile Dysfunction | 16 weeks | ||
Secondary | L-arginine plasma-levels | 16 weeks |
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