L-Arginine and Erectile Dysfunction

This study has been completed.
Sponsor:
Collaborator:
Pharmacia
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00777075
First received: October 21, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted

October 21, 2008
October 21, 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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
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.
Male
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00777075
B VP2.A-7140-00-37/4020796
No
Not Provided
Hannover Medical School
Pharmacia
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