Androgen Regulation of Priapism in Sickle Cell Disease

• ClinicalTrials.gov Identifier: NCT01940718
• Recruitment Status: Withdrawn
• First Posted: September 12, 2013
• Last Update Posted: January 19, 2017
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

Tracking Information

• First Submitted Date: September 9, 2013
• First Posted Date: September 12, 2013
• Last Update Posted Date: January 19, 2017
• Study Start Date: March 2014
• Actual Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Androgen Regulation of Priapism in Sickle Cell Disease
• Official Title: 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: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Priapism
• Sickle Cell Disease
• Hypogonadism

Intervention

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

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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: January 18, 2017): 0
• Original Estimated Enrollment (submitted: September 11, 2013): 20
• Actual Study Completion Date: January 2016
• Actual Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01940718
• Other Study ID Numbers: NA_00076088
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Johns Hopkins University
• Original Responsible Party: Arthur L. Burnett, M.D., Johns Hopkins University, Prinicipal Investigator
• Current Study Sponsor: Johns Hopkins University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Arthur L Burnett, MD, MBA; Johns Hopkins University

• PRS Account: Johns Hopkins University
• Verification Date: January 2017