Clinical Trial: Androgen Regulation of Priapism in Sickle Cell Disease

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Androgen Regulation of Priapism in Sickle Cell Disease

Brief Summary: It is believed that when androgen (testosterone) levels are below normal there is a disturbance of normal bodily functioning that is associated with priapism in some men. Conversely, it is believed that testosterone replacement will improve the condition of priapism when the testosterone levels are brought to normal. In turn, this will also improve psychological well being in men with sickle cell disease (SCD).

Detailed Summary:

The central hypothesis of this proposal is that a decline in androgen levels results in decreased action and contributes to the molecular derangements associated with priapism. Optimizing androgen status may promote regulatory molecular mechanisms that protect against priapism. This clinical trial will investigate the potential benefit of precise testosterone replacement for ameliorating priapism and improving psychological well-being in hypogonadal men with SCD.

This clinical trial aims to evaluate the efficacy of testosterone replacement therapy on the frequency of recurrent priapism in patients with SCD. The sub-hypothesis that testosterone (T) replacement to achieve serum T concentrations at a target range reduces recurrent priapism will be tested. This aim will involve subjective and objective assessments of priapism occurrences and erectile ability including priapism inventory instruments, standardized questionnaires of erectile function (EF) and quality of life, and Rigiscan™ erection monitoring in a 3.5-month pilot investigation.


Sponsor: Johns Hopkins University

Current Primary Outcome: change in frequency of priapism episodes [ Time Frame: Baseline to 3 months post intervention ]

A "Priapism sexual activity log" will be administered to participants. In the log, participants will be asked to quantify the number of priapic episodes they have experienced in the previous 2 weeks according to the following scale/tiers: 0 = no episodes, 1 = 1-2 episodes, 2 = 3-4 episodes, 3 = 5-8 episodes and 6 = greater than 20 episodes.


Original Primary Outcome: Reduction in priapism episodes [ Time Frame: 3.5 months ]

Subjects will have a reduction in the frequency of priapism episodes from baseline when a target range of serum testosterone is reached by replacement therapy.


Current Secondary Outcome:

  • change in quality of life [ Time Frame: Baseline to 3 months post intervention ]
    The RAND 12 questionnaire will be administered. This is a validated questionnaire evaluating the patient's perception of their overall health.
  • change in quality of erections [ Time Frame: Baseline to 3 months post intervention ]
    The RigiScan will be used. This is an external instrument to measure penile tumescence and rigidity
  • change in EF [ Time Frame: Baseline to 3 months post intervention ]
    The International Index of Erectile Function (IIEF) will be administered. This is a 15 item questionnaire . The questionnaire measures Erectile Function (scored from 0-30), Intercourse satisfaction (0-15), orgasmic function (0-10), Sexual Desire (2-10) and Overall satisfaction (2-10).


Original Secondary Outcome:

Information By: Johns Hopkins University

Dates:
Date Received: September 9, 2013
Date Started: March 2014
Date Completion:
Last Updated: January 18, 2017
Last Verified: January 2017