Sexual Function in Male Renal Transplant Patients
December 10, 2007 updated by: Montefiore Medical Center
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.
Study Overview
Status
Terminated
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
110
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Bronx, New York, United States, 10467
- Montefiore Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel Glicklich, MD, Montefiore Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
December 30, 2005
First Submitted That Met QC Criteria
January 3, 2006
First Posted (Estimate)
January 4, 2006
Study Record Updates
Last Update Posted (Estimate)
December 11, 2007
Last Update Submitted That Met QC Criteria
December 10, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MMCIRB05-07-184
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.