Androgen Regulation of Priapism in Sickle Cell Disease
| Status: | Withdrawn |
|---|---|
| Conditions: | Anemia, Endocrine |
| Therapuetic Areas: | Endocrinology, Hematology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 1/20/2017 |
| Start Date: | March 2014 |
| End Date: | January 2016 |
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).
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).
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.
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.
Inclusion Criteria:
- Ages 18-50
- History of SCD
- Episodes of prolonged penile erection in the absence of sexual interest or desire,
with an average frequency of at least twice weekly, when averaged over the previous
four weeks
- serum testosterone level below 550 ng/dl
- Ability to provide informed consent
Exclusion Criteria:
- Alcohol use exceeding two standard drinks daily
- Prostate conditions including prostate specific antigen (PSA) elevation (>2.5 ng/ml)
- Known sleep apnea
- Known cirrhosis
- Enlarged and painful male breasts
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