Back to resultsL-Arginine and Erectile Dysfunction
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
L-arginine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring nitrate, nitric oxide, asymmetric dimethylarginine, blood pressure, NOS, IIEF
Eligibility 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.
Sites / Locations
- Institute of Clinical Pharmacology, Hannover Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
L-arginine
placebo
Arm Description
Outcomes
Primary Outcome Measures
International Index of Erectile Dysfunction
Secondary Outcome Measures
L-arginine plasma-levels
Full Information
NCT ID
NCT00777075
First Posted
October 21, 2008
Last Updated
October 21, 2008
Sponsor
Hannover Medical School
Collaborators
Pharmacia
1. Study Identification
Unique Protocol Identification Number
NCT00777075
Brief Title
L-Arginine and Erectile Dysfunction
Official Title
Oral Administration of L-Arginine in Patients With Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hannover Medical School
Collaborators
Pharmacia
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
nitrate, nitric oxide, asymmetric dimethylarginine, blood pressure, NOS, IIEF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
57 (false)
8. Arms, Groups, and Interventions
Arm Title
L-arginine
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
L-arginine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
International Index of Erectile Dysfunction
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
L-arginine plasma-levels
Time Frame
16 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk O. Stichtenoth, MD
Organizational Affiliation
Institute of Clinical Pharmacology, Hannover Medical School
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Clinical Pharmacology, Hannover Medical School
City
Hannover
State/Province
Lower Saxony
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
L-Arginine and Erectile Dysfunction
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