NCT00777075

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2008

Completed
Last Updated

October 22, 2008

Status Verified

October 1, 2008

First QC Date

October 21, 2008

Last Update Submit

October 21, 2008

Conditions

Erectile Dysfunction

Keywords

nitratenitric oxideasymmetric dimethylarginineblood pressureNOSIIEF

Outcome Measures

Primary Outcomes (1)

  • International Index of Erectile Dysfunction

    16 weeks

Secondary Outcomes (1)

  • L-arginine plasma-levels

    16 weeks

Study Arms (2)

L-arginine

ACTIVE COMPARATOR
Drug: L-arginine

placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

L-arginineDRUG
L-arginine
PlaceboDRUG
placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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. -

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Clinical Pharmacology, Hannover Medical School

Hanover, Lower Saxony, Germany

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Arginine

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Study Officials

  • Dirk O. Stichtenoth, MD

    Institute of Clinical Pharmacology, Hannover Medical School

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 21, 2008

First Posted

October 22, 2008

Study Start

July 1, 2003

Study Completion

November 1, 2005

Last Updated

October 22, 2008

Record last verified: 2008-10

Locations

DE(1)