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. |
ClinicalTrials.gov Identifier: NCT00777075 |
Recruitment Status :
Completed
First Posted : October 22, 2008
Last Update Posted : October 22, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Erectile Dysfunction | Drug: L-arginine Drug: Placebo | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: L-arginine |
Drug: L-arginine |
Placebo Comparator: placebo |
Drug: Placebo |
- International Index of Erectile Dysfunction [ Time Frame: 16 weeks ]
- L-arginine plasma-levels [ Time Frame: 16 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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.

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
Germany | |
Institute of Clinical Pharmacology, Hannover Medical School | |
Hannover, Lower Saxony, Germany |
Study Director: | Dirk O. Stichtenoth, MD | Institute of Clinical Pharmacology, Hannover Medical School |
ClinicalTrials.gov Identifier: | NCT00777075 |
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 |
nitrate nitric oxide asymmetric dimethylarginine |
blood pressure NOS IIEF |
Erectile Dysfunction Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Mental Disorders |