Androgen Regulation of Priapism in Sickle Cell Disease
It is believed that when androgen (testosterone) levels are below normal that 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Androgen Regulation of Priapism in Sickle Cell Disease|
- Reduction in priapism episodes [ Time Frame: 3.5 months ] [ Designated as safety issue: No ]Subjects will have a reduction in the frequency of priapism episodes from baseline when a target range of serum testosterone is reached by replacement therapy.
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
Experimental: Transdermal Testosterone
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.
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 testosteron increments. The medication will be taken transdermally once daily for 3.5 months. Subjects experiencing a reduction in symptoms will be offered open label treatment for an additional 12 months.
Other Name: Androgel 1.62%
The central hypothesis of this proposal is that a decline in androgen levels and actions contributes to the molecular derangements associated with priapism and, conversely, optimizing androgen status promotes 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 (sickle cell disease).
This clinical trial will satisfy Specific Aim #3 in the translational research proposal: To evaluate the efficacy of testosterone replacement therapy on the frequency of recurrent priapism in patients with SCD. We will test the sub-hypothesis that T replacement to achieve serum T concentrations at a target range reduces recurrent priapism. This aim will involve subjective and objective assessments of priapism occurrences and erectile ability including priapism inventory instruments, standardized questionnaires of erectile function and quality of life, and Rigiscan™ erection monitoring in a 3-month "pilot" investigation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01940718
|Contact: Arthur L Burnett, MD, MBA||410 firstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins University School of Medicine, Johns Hopkins Hospital||Not yet recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Arthur L Burnett, MD, MBA 410-614-3986 email@example.com|
|Principal Investigator: Arthur L Burnett, MD, MBA|
|Principal Investigator:||Arthur L Burnett, MD, MBA||Johns Hopkins University|