Androgen Regulation of Priapism in Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT01940718|
Recruitment Status : Withdrawn (Funding could not be secured)
First Posted : September 12, 2013
Last Update Posted : January 19, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Priapism Sickle Cell Disease Hypogonadism||Drug: Transdermal Androgel||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Androgen Regulation of Priapism in Sickle Cell Disease|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
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 testosterone increments. The medication will be taken transdermally once daily for 3.5 months.
Other Name: Androgel 1.62%
- change in frequency of priapism episodes [ Time Frame: Baseline to 3 months post intervention ]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.
- change in quality of life [ Time Frame: Baseline to 3 months post intervention ]The RAND 12 questionnaire will be administered. This is a validated questionnaire evaluating the patient's perception of their overall health.
- change in quality of erections [ Time Frame: Baseline to 3 months post intervention ]The RigiScan will be used. This is an external instrument to measure penile tumescence and rigidity
- change in EF [ Time Frame: Baseline to 3 months post intervention ]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).
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|Ages Eligible for Study:||18 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940718
|United States, Maryland|
|Johns Hopkins University School of Medicine, Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Arthur L Burnett, MD, MBA||Johns Hopkins University|
|Responsible Party:||Johns Hopkins University|
|Other Study ID Numbers:||
|First Posted:||September 12, 2013 Key Record Dates|
|Last Update Posted:||January 19, 2017|
|Last Verified:||January 2017|
Sickle cell disease
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Endocrine System Diseases
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal