Androgen Regulation of Priapism in Sickle Cell Disease

NCT01940718 | Withdrawn Early Phase 1

• 1 other identifier: NA_00076088
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Priapism; Sickle Cell Disease; Hypogonadism

Keywords

Priapism; Sickle cell disease; Testosterone; Androgen deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• change in quality of life

  Baseline to 3 months post intervention

• change in quality of erections

  Baseline to 3 months post intervention

• change in EF

  Baseline to 3 months post intervention

Study Arms (1)

Transdermal Testosterone

EXPERIMENTAL

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

Interventions

Transdermal Androgel DRUG

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.

Also known as: Androgel 1.62%

Transdermal Testosterone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University School of Medicine, Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Priapism; Anemia, Sickle Cell; Hypogonadism

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Arthur L Burnett, MD, MBA

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 12, 2013
• Study Start: March 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 19, 2017

Record last verified: 2017-01

Locations

US (1)