Androgen Regulation of Priapism in Sickle Cell Disease

Sickle Cell Disease Clinical Trial

Official title:

Androgen Regulation of Priapism in Sickle Cell Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01940718
• Other study ID #: NA_00076088
• Status: Withdrawn
• Phase: N/A
• First received: September 9, 2013
• Last updated: January 18, 2017
• Start date: March 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Hypogonadism
• Priapism
• Sickle Cell Disease

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.

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine, Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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