Clinical trial NCT01940718: Androgen Regulation of Priapism in Sickle Cell Disease
Official title: Androgen Regulation of Priapism in Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Priapism
Sickle Cell Disease
Hypogonadism
Keywords: Priapism
Sickle cell disease
Testosterone
Androgen deficiency
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2013-09-12
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: change in frequency of priapism episodes
timeFrame: Baseline to 3 months post intervention
Secondary outcomes:
measure: change in quality of life
timeFrame: Baseline to 3 months post intervention
measure: change in quality of erections
timeFrame: Baseline to 3 months post intervention
measure: change in EF
timeFrame: Baseline to 3 months post intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine, Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Arthur L Burnett, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: