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L-Arginine and Erectile Dysfunction

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

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 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

Resource links provided by the National Library of Medicine


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



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 ]


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00777075     History of Changes
Other Study ID Numbers: B VP2.A-7140-00-37/4020796
First Posted: October 22, 2008    Key Record Dates
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