L-Arginine and Erectile Dysfunction

Phase 4

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: Placebo; Drug: L-arginine

• Registration Number: NCT00777075
• Lead Sponsor: Hannover Medical School

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 production of NO from L-arginine. ADMA, a competitive inhibitor of NO synthase increases with age and many disorders that reduce NO in the erectile tissue are commonly associated with ED. Although new pharmacological strategies have been identified for medical treatment of ED, patients often seek alternative therapies for cost or side effect reasons.

The aim of the present study is to determine the efficacy of orally administered L-arginine on ED not caused by established organic disease.

Study Timeline

• Study Start: 2003-07
• Study Completion: 2005-11
• Status Verified: 2008-10
• Study First Submitted: 2008-10-21
• Study First Submitted QC: 2008-10-21
• Last Update Submitted: 2008-10-21
• Study First Posted: 2008-10-22
• Last Update Posted: 2008-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 57

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. -

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	-
L-arginine	L-arginine	-

Primary Outcome Measures

Name	Time	Method
International Index of Erectile Dysfunction	16 weeks

Secondary Outcome Measures

Name	Time	Method
L-arginine plasma-levels	16 weeks

Trial Locations

Locations (1)

Institute of Clinical Pharmacology, Hannover Medical School; 🇩🇪 Hannover, Lower Saxony, Germany