WithdrawnEarly Phase 1

Androgen Regulation of Priapism in Sickle Cell Disease

Stopped: Funding could not be secured

United States0Started 2014-03

Plain-language 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).

Who can participate

Age range18 Years – 50 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

change in frequency of priapism episodes

Timeframe: Baseline to 3 months post intervention

Trial details

NCT IDNCT01940718

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-01

View on ClinicalTrials.gov More Priapism trials