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
  Purpose

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 Intervention Phase
Erectile Dysfunction
Drug: L-arginine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Oral Administration of L-Arginine in Patients With Erectile Dysfunction

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • International Index of Erectile Dysfunction [ Time Frame: 16 weeks ]

Secondary Outcome Measures:
  • L-arginine plasma-levels [ Time Frame: 16 weeks ]

Estimated Enrollment: 57
Study Start Date: July 2003
Estimated Study Completion Date: November 2005
Arms Assigned Interventions
Active Comparator: L-arginine Drug: L-arginine
Placebo Comparator: placebo Drug: Placebo

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00777075

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

No publications provided

ClinicalTrials.gov Identifier: NCT00777075     History of Changes
Other Study ID Numbers: B VP2.A-7140-00-37/4020796
Study First Received: October 21, 2008
Last Updated: October 21, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Sexual and Gender Disorders
Mental Disorders
N,N-dimethylarginine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014