Androgen Regulation of Priapism in Sickle Cell Disease

Johns Hopkins University

Status and phase: Withdrawn; Early Phase 1

Conditions: Priapism; Sickle Cell Disease; Hypogonadism

Treatments: Drug: Transdermal Androgel

Study type: Interventional

Funder types: Other

Identifiers

NCT01940718

NA_00076088

Details and patient eligibility

About

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).

Full 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.

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Transdermal Testosterone

Experimental group

Description:

Transdermal Androgel 1.62% (20.25 mg testosterone = 1 pump actuations) to be applied once daily for 3.5 months. Initial dose will be at lowest level, 20.25 mg testosterone with dosing adjustments given in 20.25 mg testosterone increments.

Treatment:

Drug: Transdermal Androgel