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Androgen Regulation of Priapism in Sickle Cell Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01940718
Recruitment Status : Withdrawn (Funding could not be secured)
First Posted : September 12, 2013
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Priapism Sickle Cell Disease Hypogonadism Drug: Transdermal Androgel Early Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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Arms and Interventions
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Arm Intervention/treatment
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%


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Maryland
Johns Hopkins University School of Medicine, Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Arthur L Burnett, MD, MBA Johns Hopkins University
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01940718    
Other Study ID Numbers: NA_00076088
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017
Keywords provided by Johns Hopkins University:
Priapism
Sickle cell disease
Testosterone
Androgen deficiency
Additional relevant MeSH terms:
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Priapism
Anemia, Sickle Cell
Hypogonadism
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Penile Diseases
Genital Diseases, Male
Genital Diseases
 Urogenital Diseases
Male Urogenital Diseases
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents