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| |  Minocycline Treatment Shows No Adverse Impact on Spermatogenesis: Presented at AAD By Perrie Susman MIAMI BEACH, Fla -- March 10, 2010 -- Three months of treatment with minocycline hydrochloride, a semisynthetic derivative of tetracycline, does not appear to impact spermatogenesis, researchers reported here at the 68th Annual Meeting of the American Academy of Dermatology (AAD). “The results of this study indicate that human spermatogenesis and circulating levels of circulating follicle-stimulating hormone and testosterone are unaffected by the administration of extended release-minocycline for up to 12 weeks,” said Larry Lipshultz, MD, Baylor College of Medicine, Houston, Texas, during a poster presentation on March 7. The primary objective of the study was to investigate the effects of extended release minocycline on several parameters of human spermatogenesis because of reports that minocycline might produce adverse effects. The study enrolled 180 healthy adult men. Researchers randomly assigned 91 men to treatment to extended release minocycline ~1 mg/kg daily for 12 weeks and 89 men were given a placebo. The 12-week treatment period corresponds to the approved product label and exceeds the human 75-day spermatogenesis cycle. The report at AAD evaluated results on those who completed the trial: 72 minocycline-treatment men and 73 other men on placebo. When the number of minocycline-treated and placebo-treated subjects with a 50% reduction in sperm concentration, a 50% reduction in motility, and a 20% reduction in normal morphology were compared, researchers were unable to discern a statistically significant difference. For example, about 11.1% of the men receiving minocycline experienced a 50% reduction in sperm concentration compared with 11% of men on placebo. None of these healthy volunteers experienced a 50% reduction in sperm motility compared with 1.4% of men on placebo. About 28% of men receiving minocycline experienced a 20% reduction in normal morphology compared with 32.9% of men taking placebo. The researchers also measured these levels at weeks 16, 20, and 24 and did not find any significant differences at each time point test. The mean follicle-stimulating hormone and testosterone levels were similar between men receiving minocycline and those receiving placebo. “Adverse events were reported in 33 subjects (36.3%) in the minocycline group and 27 subjects (30.3%) in the placebo group,” Dr. Lipshultz reported. In the double-blind, placebo-controlled multicentre study, 2 semen samples were obtained at each time point and the results were averaged for all statistical analyses. Safety assessments included a physical examination performed during screening and after 12 and 16 weeks; clinical chemistry and haematology during the screening period and after 4 and 12 weeks; antinuclear antibodies; thyroid function tests; and reports of adverse events. Following the baseline evaluation, blood and semen samples were collected after 12, 16, 20, and 24 weeks. Funding for this study was provided by Medicis Pharmaceutical Corporation. [Presentation title: Human Spermatogenesis Is Unaffected by 12 Weeks of Treatment With Lowdose Extended Release Minocycline. Abstract P700]
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