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| |  Intramuscular Testosterone Undecanoate More Effective Than Oral Formulation for Hypogonadotropic Hypogonadism: Presented at ECE By Chris Berrie BERLIN -- May 8, 2008 -- Intramuscular (IM) testosterone undecanoate (TU) is more efficacious for maintenance of normal morning testosterone levels and improved sexual function than oral TU in adult men with hypogonadotropic hypogonadism (HH), according to a retrospective study presented here at the 10th European Congress of Endocrinology (ECE). "We have a lot of patients with pituitary insufficiency, including gonadotropin insufficiency, and we treated them with oral testosterone undecanoate, which was the only treatment for several years in our country," explained principal investigator Monica Livia Gheorghiu, MD, PhD, Consultant, Department of Endocrinology, Carol Davila University of Medicine and Pharmacy, and C.I. Parhon Institute of Endocrinology, Bucharest, Romania. The aim of the study was therefore to determine the clinical efficacy of IM TU in comparison with oral TU for androgen replacement therapy in adult men with HH, Dr. Gheorghiu said in a presentation on May 5. Diagnosis for symptomatic HH was low morning levels of total testosterone in serum and low to low/normal levels of follicle stimulating hormone and luteinising hormone. On this basis, 41 male patients were enrolled and evaluated before and after receiving androgen replacement therapy. Of these patients, 30 had pituitary tumours or craniopharyngiomas, and 11 had nontumour gonadotropin deficiency. Twenty-eight men in the oral TU group (median age, 49 years) received 40-mg tablets at a median dosage of 120 mg/day, in 3 divided doses, for a median of 14 months. Twenty men in the IM-TU group (median age, 43 years) received a dose of 1,000 mg, generally repeated at 6 weeks and then at 12-week intervals for a median of 6 months. A further subgroup included 7 patients with initial oral TU who were switched to IM TU without a wash-out period (oral/IM-TU group). Samples of fasting venous blood were obtained between 8:00 and 9:30 AM, and were tested for levels of total testosterone, total cholesterol, triglycerides, and haemoglobin. Sexual dysfunction was evaluated during patient anamnesis through questions on libido, frequency, and quality of erections. The oral TU group achieved significant increases in mean serum testosterone level from baseline (0.37-1.43 ng/mL, P < .01). A larger significant increase was seen for the IM-TU group (0.88-5.88 ng/mL, P < .01). The oral/IM-TU subgroup showed significant increases for oral TU to 1.33 ng/mL that increased significantly further to 5.49 mg/mL with IM TU (P < .01). Although serum lipid levels did not change significantly for any treatment groups, changes in patient haematocrit levels paralleled those for testosterone: significant increases from baseline for oral TU (38.1% vs 41.0%, P < .01) and IM TU (38.8% vs 41.9%, P < .01), and the change from oral to IM TU showed low but significant improvement (38.7% vs 42.7%, P < .01). For self-reported effects on sexual function, IM-TU saw benefits over oral TU for both improved sexual function (55% vs 25%, respectively) and decreased persistent sexual dysfunction (5% vs 32%, respectively). "Treatment should be individualised to each patient, because there are several aspects that we have to take into consideration, like the longer duration for the injectable testosterone undecanoate, which may not be favourable in older patients," Dr Gheorghiu noted. "And it's easier to take oral pills."
[Presentation title: Clinical Efficacy of Intramuscular Versus Oral Testosterone Undecanoate in Adult Men With Hypogonadotropic Hypogonadism. Abstract P160]
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