Androgen Regulation of Priapism in Sickle Cell Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Androgen Regulation of Priapism in Sickle Cell Disease

Conditions
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Priapism, Sickle Cell Disease, Hypogonadism

Intervention / Treatment
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* Drug: Transdermal Androgel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transdermal Testosterone<br>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<br>* 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.<br>* Other names: Androgel 1.62%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in frequency of priapism episodes | A Priapism sexual activity log will be administered to participants. In the log, participants will be asked to quantify the number of priapic episodes they have experienced in the previous 2 weeks according to the following scale/tiers: 0 = no episodes, 1 = 1-2 episodes, 2 = 3-4 episodes, 3 = 5-8 episodes and 6 = greater than 20 episodes. | Baseline to 3 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in quality of life | The RAND 12 questionnaire will be administered. This is a validated questionnaire evaluating the patient's perception of their overall health. | Baseline to 3 months post intervention | 
| change in quality of erections | The RigiScan will be used. This is an external instrument to measure penile tumescence and rigidity | Baseline to 3 months post intervention | 
| change in EF | The International Index of Erectile Function (IIEF) will be administered. This is a 15 item questionnaire . The questionnaire measures Erectile Function (scored from 0-30), Intercourse satisfaction (0-15), orgasmic function (0-10), Sexual Desire (2-10) and Overall satisfaction (2-10). | Baseline to 3 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Priapism, Sickle cell disease, Testosterone, Androgen deficiency