Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males

NCT00313898

Last updated date
Study Location
Rambam Health Care Campus
Haifa, , 31096, Israel
Contact
00972-4-8542819

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Erectile Dysfunction
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
35-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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) .

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males
Official Title  ICMJE The Effect of Treatment for ED on Quality of Life and Satisfaction in a Group of Patients Without Prior Complaints of Sexual Dysfunction
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.

Detailed Description

This will be a prospective, placebo-controlled, double blind crossover study. One hundred males between 35-70 years of age in good general health will be included. Recruitment of patients will be done through patient referral to the "male sexual dysfunction clinic" at Rambam Medical Center, as well as by other necessary ways for optimal and rapid recruitment (media advertisement, direct contact with primary clinics etc.).

For each patient, the study will terminate after a maximal period of 4 months from initiation and will include 4 visits:

On inclusion (Visit I), a thorough explanation will be given to each patient on the aims and course of the study, as well as a full explanation on dosage, mode of administration, safety and efficacy of Viagra. After reading and signing an informed consent, each patient will be asked to fill a questionnaire regarding his sexual function (IIEF-ED Domain). If the patient fits inclusion criteria, he will be referred to the urologist to initiate the study. On the second encounter (Visit II), medical history and physical exam will be performed. The subject will then fill out 3 questionnaires: IIEF (full version), QVS (quality of sexual life questionnaire) and the SEARS questionnaire. Administration of medication will be performed in a double-blinded crossover fashion. Each patient will be provided, at random either 6 tablets of placebo or Viagra? 50mg. The patient will be advised to use them on demand. After consuming all 6 tablets, a third visit will be scheduled. On the third visit (Visit III) each patient will be provided with new IIEF (full version), QVS (quality of sexual life questionnaire), the SEARS questionnaire and an EDITS questionnaire. A few other questions on satisfaction will be asked and recorded (questions on the quality of the erection, duration of intercourse, number of sexual acts per night, frequency of intercourse/week, satisfaction from intercourse etc). Each subject will receive another 6 tablets (Viagra/ placebo). Finally, at the last visit (Visit IV) subjects will again fill out the same questionnaires as on visit III. At the end of the study, double-blind codes will be opened and multi-variant analysis of the data will be performed using chi square and annova.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Erectile Dysfunction
Intervention  ICMJE Drug: sildenafil (viagra)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 11, 2006)
100
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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) .

Exclusion criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00313898
Other Study ID Numbers  ICMJE viagracommCTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Rambam Health Care Campus
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Ilan Gruenwald, MDIsrael Urology association
PRS Account Rambam Health Care Campus
Verification Date April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP