title: Testosterone replacement therapy does not promote priapism in hypogonadal men with sickle cell disease: 12-month safety report.
abstract: Hypogonadism, which is highly prevalent in men with sickle cell disease (SCD), affects quality of life and causes great morbidity. The safety of testosterone replacement therapy (TRT) in SCD in relation to priapism episodes is relatively unknown. Our aim was to monitor the safety of TRT in a cohort of seven hypogonadal men with SCD. Testosterone undecanoate (Nebido) 1 g was administered intramuscularly to adult men with homozygous SCD (Hb SS) having hypogonadism [serum total testosterone ≤12.0 nmol/L (346 ng/dL), reference range 12.5-38.1 nmol/L (360-1098 ng/dL)] for 12 months. Serum total testosterone, haemoglobin, haematocrit, renal and liver function tests, glucose and PSA measurements were done at baseline and 12-month follow-up. Trough serum total testosterone, haemoglobin and haematocrit were measured three monthly. Priapism events and adverse drug events were assessed every 3 months. International Index of Erectile Function (IIEF), Androgen Deficiency in the Ageing Male (ADAM) and World Health Organization Quality of Life (WHOQOL) questionnaires were administered at baseline, 6 and 12 months. Seven men with a mean age of 34.4 years were treated. Median total testosterone increased from 10.6 to 11.2 nmol/L (p = 0.46). Median serum lactate dehydrogenase levels decreased from 1445 to 1143.5 IU/L (p < 0.05), while all other laboratory indices remained stable. Injection site pain was the most frequently reported adverse event, with no increases in painful crises, hypersensitivity or oedema. After TRT, there was no significant increase in priapism frequency. Median questionnaire scores were increased for the IIEF (46-68, p = 0.018), reduced for ADAM (5.0-2.0, p = 0.016) and unchanged for WHOQOL (98-103, p = 0.086). TRT using testosterone undecanoate with eugonadal intent for hypogonadism appears to be safe in men with SCD. This treatment does not appear to promote priapism occurrences and rather it possibly improves sexual function. Future prospective evaluations in larger groups of hypogonadal men with SCD are necessary to confirm these findings.
authors.affiliation: Department of Surgery, University of the West Indies, Mona, Jamaica. bfmorrison11@hotmail.com
authors.forename: B F
authors.initials: BF
authors.lastname: Morrison
authors.forename: M
authors.initials: M
authors.lastname: Reid
authors.forename: W
authors.initials: W
authors.lastname: Madden
authors.forename: A L
authors.initials: AL
authors.lastname: Burnett
mesh_terms: D000328:Adult; D000755:Anemia, Sickle Cell / Q000097:blood / Q000150:complications* / Q000235:genetics; D015415:Biomarkers / Q000097:blood; D020022:Genetic Predisposition to Disease; D006451:Hemoglobin, Sickle / Q000235:genetics; D006720:Homozygote; D020249:Hormone Replacement Therapy / Q000009:adverse effects*; D006801:Humans; D007006:Hypogonadism / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D007273:Injections, Intramuscular; D007563:Jamaica; D008297:Male; D010410:Penile Erection / Q000187:drug effects; D010865:Pilot Projects; D011317:Priapism / Q000139:chemically induced*; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013739:Testosterone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood / Q000172:deficiency; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D006451:Hemoglobin, Sickle; D013739:Testosterone; C010792:testosterone undecanoate