L-Arginine and Erectile Dysfunction

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hannover Medical School
• Collaborator: Pharmacia

Criteria

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.