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Sexual Function in Male Renal Transplant Patients

This study has been terminated.
Sponsor:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00271830
First received: December 30, 2005
Last updated: December 10, 2007
Last verified: December 2007
History of Changes
  Purpose

Sexual dysfunction is common in male patients with chronic renal failure on dialysis and after renal trasnplantation. Multiple factors play a role in this important clinical problem. Recent studies suggest that certain immunosuppressive medication used for solid organ transplant may affect male sexual function. The purpose of this study is to compare the sexual function of male renal transplant patients on sirolimus and those patients not on sirolimus immunosuppression.


Condition
Renal Transplant Recipients

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Sexual Function in Male Renal Transplant Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Montefiore Medical Center:

Estimated Enrollment: 110
Study Start Date: January 2006
Study Completion Date: August 2007
Detailed Description:

All male renal transplant recipients with a functioning allograft 1 month post transplant will be eligible to participate in this prospective serial observation study. As roughly half of renal transplant patients are assigned to rapamycin immunnosuppression clinically and half are not, we plan to assess routine clinical perameters, sex hormone levels, subjective sexual function as measured by standardized questionnaire and semen analysis in 55 patients on sirolimus treatment and 55 patients not on this treatment. Assessment will be made at baseline (1 mo post transplant) and 6 and 12 months later. All adult male renal transplant recipients ages 21-65 off dialysis 1 mo post transplant will be eleigible. Exclusion criteria will be female gender, patients requiring testosterone therapy, patients on dialysis, and those unwilling to give informed consent.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:male renal transplant recipients off dialysis by 1 month post transplant, ages 21-65,willing to give informed consent

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Exclusion Criteria: female gender, patients requiring testosterone replacement treatment, patients with neglibile renal function requiring dialysis, unwilling to give informed consent

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271830

Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Daniel Glicklich, MD Montefiore Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00271830     History of Changes
Other Study ID Numbers: MMCIRB05-07-184
Study First Received: December 30, 2005
Last Updated: December 10, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
renal
transplant
sexual dysfunction
male
dialysis free

ClinicalTrials.gov processed this record on May 19, 2013