NCT01940718

Androgen Regulation of Priapism in Sickle Cell Disease

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Priapism
• Sickle Cell Disease
• Hypogonadism

Interventions

Type	Name	Description
DRUG	Transdermal Androgel	T dosing will be initiated at the lowest possible level (20.25 mg testosterone = 1 pump actuation) which is expected to increase average serum T concentrations no higher than the mid-normal range (500-800 ng/dl), with respect to expected baseline measurements in our population (\~300-500 ng/dl).The T dose will be adjusted two weeks after initiation of treatment based on the measurement of serum T levels. Dosing adjustments can be made at 20.25 mg testosterone increments. The medication will be taken transdermally once daily for 3.5 months.

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2013-09-12
• Last updated: 2017-01-19

Locations

1 site across 1 country: United States