L-Arginine and Erectile Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00777075
Recruitment Status : Completed
First Posted : October 22, 2008
Last Update Posted : October 22, 2008
Information provided by:
Hannover Medical School

October 21, 2008
October 22, 2008
October 22, 2008
July 2003
Not Provided
International Index of Erectile Dysfunction [ Time Frame: 16 weeks ]
Same as current
No Changes Posted
L-arginine plasma-levels [ Time Frame: 16 weeks ]
Same as current
Not Provided
Not Provided
L-Arginine and Erectile Dysfunction
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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Erectile Dysfunction
  • Drug: L-arginine
  • Drug: Placebo
  • Active Comparator: L-arginine
    Intervention: Drug: L-arginine
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2005
Not Provided

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.
Sexes Eligible for Study: Male
20 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
B VP2.A-7140-00-37/4020796
Not Provided
Not Provided
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Hannover Medical School
Study Director: Dirk O. Stichtenoth, MD Institute of Clinical Pharmacology, Hannover Medical School
Hannover Medical School
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP