Androgen Regulation of Priapism in Sickle Cell Disease

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Arthur L. Burnett, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01940718
First received: September 9, 2013
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

It is believed that when androgen (testosterone) levels are below normal that 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.


Condition Intervention
Priapism
Sickle Cell Disease
Drug: Transdermal Androgel

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Androgen Regulation of Priapism in Sickle Cell Disease

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Reduction in priapism episodes [ Time Frame: 3.5 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: March 2014
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 testosteron increments. The medication will be taken transdermally once daily for 3.5 months. Subjects experiencing a reduction in symptoms will be offered open label treatment for an additional 12 months.
Other Name: Androgel 1.62%

Detailed Description:

The central hypothesis of this proposal is that a decline in androgen levels and actions contributes to the molecular derangements associated with priapism and, conversely, optimizing androgen status promotes 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 (sickle cell disease).

This clinical trial will satisfy Specific Aim #3 in the translational research proposal: To evaluate the efficacy of testosterone replacement therapy on the frequency of recurrent priapism in patients with SCD. We will test the sub-hypothesis that T replacement to achieve serum T concentrations at a target range reduces recurrent priapism. This aim will involve subjective and objective assessments of priapism occurrences and erectile ability including priapism inventory instruments, standardized questionnaires of erectile function and quality of life, and Rigiscan™ erection monitoring in a 3-month "pilot" investigation.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 18-50
  • History of sickle cell disease
  • 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
  • Low androgen levels, defined as serum testosterone level below 550 ng/dl
  • Ability to provide informed consent

Exclusion Criteria:

  • Alcohol use exceeding two standard drinks daily
  • Prostate conditions including PSA (prostate specific antigen) elevation (>2.5 ng/ml)
  • Known sleep apnea
  • Known cirrhosis
  • Enlarged and painful male breasts
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01940718

Contacts
Contact: Arthur L Burnett, MD, MBA 410 614-3986 aburnett@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University School of Medicine, Johns Hopkins Hospital Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Arthur L Burnett, MD, MBA    410-614-3986    aburnett@jhmi.edu   
Principal Investigator: Arthur L Burnett, MD, MBA         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Arthur L Burnett, MD, MBA Johns Hopkins University
  More Information

No publications provided

Responsible Party: Arthur L. Burnett, M.D., Prinicipal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01940718     History of Changes
Other Study ID Numbers: NA_00076088
Study First Received: September 9, 2013
Last Updated: September 11, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Priapism
Sickle cell disease
Male

Additional relevant MeSH terms:
Penile Diseases
Anemia, Sickle Cell
Priapism
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Genital Diseases, Male
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Androgens
Methyltestosterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on July 23, 2014