title: Effects of testosterone undecanoate as a male contraceptive candidate on rat immunological features.
abstract: Testosterone undecanoate (TU) is under phase III clinical trial as a hormonal male contraceptive in China. Sex hormones can modulate the immune system. Female hormonal contraceptives may affect SIV/HIV-1 transmission. To evaluate the safety of TU and to understand whether long-term use of TU for a male contraceptive affects users' immunological features, adult male rats were treated for a 32-week TU-treated phase at the dose of 20 mg TU/kg body weight and a 24-week recovery phase. The reproductive and immunological parameters of 4-6 rats in each subgroup were examined at the stated time point. The mean sperm count and viability in the treated rats were significantly suppressed (p < 0.01). In the TU-treated group: the mean blood leukocyte and lymphocyte counts; the proliferation indexes of T cells from peripheral blood mononuclear cells (PBMC) and spleen; and, of B cells from spleen, as well as the mean counts of blood T, NK, and B cells decreased in comparison with those of control group. These decreases were not significant (p > 0.01). Similarly, the mean serum IgM, IgG, and IgA levels and complement activity in TU-treated rats were lower than those in control group (p > 0.01), and the changes in the antibody levels of the examined genital secretions were not significant (p > 0.01). The changes in the thickness of urethra epithelium, and in secretory component (SC) expression in genitals were not observed in the treated group. These results demonstrated that long-term supraphysiological TU injection did not obviously affect the examined rat immunological parameters.
authors.affiliation: Laboratory for Molecular and Cell Immunology, Kunming Institute of Zoology, The Chinese Academy of Sciences, Kunming, Yunnan, PR China.
authors.forename: Mingcan
authors.initials: M
authors.lastname: Yu
authors.forename: Xiaomei
authors.initials: X
authors.lastname: Cao
authors.forename: Jinju
authors.initials: J
authors.lastname: Xu
authors.forename: Xiaolei
authors.initials: X
authors.lastname: Wang
authors.forename: Jing
authors.initials: J
authors.lastname: Yang
authors.forename: Xinghai
authors.initials: X
authors.lastname: Wang
authors.forename: Kunlong
authors.initials: K
authors.lastname: Ben
mesh_terms: D000818:Animals; D003165:Complement System Proteins / Q000378:metabolism; D003272:Contraceptive Agents, Male / Q000633:toxicity*; D005260:Female; D005837:Genitalia, Male / Q000187:drug effects / Q000276:immunology; D006801:Humans; D007109:Immunity / Q000187:drug effects*; D007136:Immunoglobulins / Q000378:metabolism; D007958:Leukocyte Count; D008213:Lymphocyte Activation / Q000187:drug effects; D016131:Lymphocyte Subsets / Q000187:drug effects / Q000276:immunology; D008297:Male; D051381:Rats; D017207:Rats, Sprague-Dawley; D012098:Reproduction / Q000187:drug effects; D012449:Safety; D013076:Sperm Count; D013739:Testosterone / Q000031:analogs & derivatives* / Q000633:toxicity*; D013997:Time Factors; D014521:Urethra / Q000187:drug effects / Q000473:pathology
chemical_list: D003272:Contraceptive Agents, Male; D007136:Immunoglobulins; D013739:Testosterone; D003165:Complement System Proteins; C010792:testosterone undecanoate