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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Recruitment Status : Withdrawn (Funding could not be secured)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

Tracking Information
First Submitted Date  ICMJE September 9, 2013
First Posted Date  ICMJE September 12, 2013
Last Update Posted Date January 19, 2017
Study Start Date  ICMJE March 2014
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2013)
Reduction in priapism episodes [ Time Frame: 3.5 months ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2017)
  • 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).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Androgen Regulation of Priapism in Sickle Cell Disease
Official Title  ICMJE Androgen Regulation of Priapism in Sickle Cell Disease
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Priapism
  • Sickle Cell Disease
  • Hypogonadism
Intervention  ICMJE 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%
Study Arms  ICMJE 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.
Intervention: Drug: Transdermal Androgel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 18, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2013)
20
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01940718
Other Study ID Numbers  ICMJE NA_00076088
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arthur L Burnett, MD, MBA Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP