Androgen Regulation of Priapism in Sickle Cell Disease

• Status: Withdrawn
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Androgens; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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