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Androgen Regulation of Priapism in Sickle Cell Disease

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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Withdrawn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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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