NCT00313898

Brief Summary

In clinical practice it is quite common to have sexually active male patients with mild/normal erectile function that are not satisfied with their sexual function. The aim of this study is to evaluate the effect of sildenafil on the quality of sexual function in this group of patients. The endpoint of this study is to define another, different group of patients that may respond positively to treatment with sildenafil.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

May 17, 2007

Status Verified

April 1, 2006

First QC Date

April 10, 2006

Last Update Submit

May 16, 2007

Conditions

Erectile Dysfunction

Keywords

quality of sexual life, Mild erectile dysfunction

Outcome Measures

Primary Outcomes (1)

  • changes in scoring of quality of sexual life questionnaires before vs after treatment

Secondary Outcomes (1)

  • changes in scoring of erectile function domain

Interventions

sildenafil (viagra)DRUG

Eligibility Criteria

Age35 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sexually active males.
  • All males between 35-70 years of age that previously have not taken any PDE5 inhibitors.
  • A score of 22/30 and above of the International Index of Erectile Function (IIEF) ED domain (questions 1,2,3,4,5,15) .

You may not qualify if:

  • Patients with psychiatric disorders
  • Patients with contraindications to sildenafil (patients on nitrate prescription, very low blood pressure, multiple anti-hypertensive medications, allergy to PDE5i, severe renal or hepatic insufficiency etc)
  • Patients with a severe coronary artery disease
  • Patients with premature ejaculation as their primary problem without a current partner.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 31096, Israel

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ilan Gruenwald, MD

    Israel Urology association

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilan Gruenwald, MD

CONTACT

00972-4-8542819i_gruenwald@rambam.health.gov.il

Yoram Vardi, Prof

CONTACT

00972-4-8542819yvardi@rambam.health.gov.il

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

April 10, 2006

First Posted

April 12, 2006

Study Start

September 1, 2005

Study Completion

June 1, 2007

Last Updated

May 17, 2007

Record last verified: 2006-04

Locations

IL(1)