L-Arginine and Erectile Dysfunction

• ClinicalTrials.gov Identifier: NCT00777075
• Recruitment Status: Completed
• First Posted: October 22, 2008
• Last Update Posted: October 22, 2008
• Sponsor: Hannover Medical School
• Collaborator: Pharmacia
• Information provided by: Hannover Medical School

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Erectile Dysfunction	Drug: L-arginine; Drug: Placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Oral Administration of L-Arginine in Patients With Erectile Dysfunction
• Study Start Date: July 2003
• Study Completion Date: November 2005

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: L-arginine	Drug: L-arginine
Placebo Comparator: placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures :

1. International Index of Erectile Dysfunction [ Time Frame: 16 weeks ]

Secondary Outcome Measures :

1. L-arginine plasma-levels [ Time Frame: 16 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Germany

Institute of Clinical Pharmacology, Hannover Medical School

Hannover, Lower Saxony, Germany

Sponsors and Collaborators

Hannover Medical School

Pharmacia

Investigators

• Study Director: Dirk O. Stichtenoth, MD; Institute of Clinical Pharmacology, Hannover Medical School

More Information

• ClinicalTrials.gov Identifier: NCT00777075
• Other Study ID Numbers: B VP2.A-7140-00-37/4020796
• First Posted: October 22, 2008
• Last Update Posted: October 22, 2008
• Last Verified: October 2008

Keywords provided by Hannover Medical School:

nitrate; nitric oxide; asymmetric dimethylarginine; blood pressure; NOS; IIEF

Additional relevant MeSH terms:

Erectile Dysfunction; Sexual Dysfunction, Physiological; Genital Diseases, Male; Sexual Dysfunctions, Psychological; Mental Disorders