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NCT00271830 Clinical Trial

Sexual Function in Male Renal Transplant Patients

Renal Transplant Recipients Clinical Trial

Official title:
Sexual Function in Male Renal Transplant Patients

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00271830
Other study ID # MMCIRB05-07-184
Secondary ID
Status Terminated
Phase N/A
First received December 30, 2005
Last updated December 10, 2007
Start date January 2006
Est. completion date August 2007

Study information
Verified date December 2007
Source Montefiore Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 110
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria:male renal transplant recipients off dialysis by 1 month post transplant, ages 21-65,willing to give informed consent

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Montefiore Medical Center Bronx New York

Sponsors (1)
Lead Sponsor Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

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