Status:
COMPLETED
L-Arginine and Erectile Dysfunction
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
Pharmacia
Conditions:
Erectile Dysfunction
Eligibility:
MALE
20-65 years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
Erectile dysfunction (ED) is a common medical disorder often affecting the aging male. Nitric oxide (NO) is a physiological signal essential to penile erection. NO synthase (NOS) catalyzes the product...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00777075
Start Date
July 1 2003
End Date
November 1 2005
Last Update
October 22 2008
Active Locations (1)
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1
Institute of Clinical Pharmacology, Hannover Medical School
Hanover, Lower Saxony, Germany