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Suppression of spermatogenesis by testosterone undecanoate-loaded injectable in situ-forming implants in adult male rats

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Asian Journal of Andrology 2016年第5期18卷 791-797页

作者： Xiao-Wei Zhang Chong Zhang Wei Zhang Dan Yang Shu Meng Ping Wang Jing Guo Dan-Hua Liu Drug Research Laboratory Liaoning Research Institute of Family Planning Huanggu District Shenyang China

We have investigated the feasibility of administration of testosterone undecanoate （TU）-Ioaded injectable in situ-forming implant （ISFI） for contraception in adult male Sprague-Dawley rats. Male rats were treated with vehicle, TU-Ioaded ISFIs （540, 270 and 135 mg TU kg-1） or TU injections （45 mg TU kg-1 every 30 days） for 120 days. Fertility tests served for determining infertility or restoration of fertility in treated rats. Serum testosterone concentration, epididymal sperm count, motility, morphology, and histology of the testis were monitored. The TU-Ioaded ISFIs increased serum testosterone levels in rats steadily without fluctuation over 3 months. One month after TU administration, the epididymal sperm count decreased significantly in all experimental groups. After 3 months, the animals treated with 270 and 135 mg kg-~ TU-Ioaded ISFIs were 100% infertile, and no implantation sites were produced in the mated females. However, some of males treated with 540 mg kg-~ ISFI or TU injections were still fertile but numbers of implantation sites were also significantly lower than control values. TU-Ioaded ISFI at an appropriate dose has potential as a long-acting male contraceptive drug that suppresses spermatogenesis consistently over a period of 3 months.

关键词： in situ-forming implants male contraception rats spermatogenesis testosterone undecanoate

Studies on apoptosis of spermatogenic cells in normal fertile men treated with supraphysiological doses of testosterone undecanoate

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Asian Journal of Andrology 1999年第3期1卷 155-158页

作者： Yi-FengGE Yu-FengHUANG Gui-YuaaZHANG Xinghaiwang jianpingxu Laboratoryofreproductionandgenetics generalhospitalofnanjingcommandplananjing210002china Nationalresearchinstitudeforfamilyplanning beijing100018china Jiangsufamtityplanrringresearchinstinute nanjing210029china

Aim: To study the anti-spermatogenic mechanism of supra-physiological doses of testosterone undecanoate (TU).Methods: Twenty fertile adult men received four intramuscular injections of TU at monthly intervals, 1000 mg uponadmission and 500 mg for the subsequent injections. The apoptotic germ cells in the semen were studied under light mi-croscope with tenninal deoxynucleotidyl tmnsferase-mediated dUTP-biotin nick end labeling (TUNEL) and Wright-Giem-sa staining methods. Results: After treatment, the sperm density and the number of spermatogenic cells in the semenwere significantly decreased ( P < 0.01), while the apoptotic ratios of spermatocytes and spermatids increased significantly( P <0.01) as compared with the pretreatment levels. Apoptosis was found to be augmented in the whole series of castoffspennatogenic cells. Conclusion: Besides its suppressive effect on spermatogenesis through a negative feed-backmechanism, TU enhances apoptosis of spermatogenic cells, which may be an additional mechanism of its anti-spermato-genic activity. ( Asian J Androl 1999 Sep; 1: 155 - 158)

关键词： anti-spermatogenic effect testosterone undecanoate apoptosis germ cells semen

Effectiveness of testosterone undecanoate Treatment in Men with Asthenospermia

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Journal of Reproduction and Contraception 2012年第2期23卷 119-126页

作者： Bo SONG Zhi-ming CAI Guangdong Key Lab Male Reproductive Medicine&GeneticsShenzhen HospitalPeking UniversityShenzhen 518036China

Objective To assess the effectiveness of testosterone undecanoate on sperm motility and pregnancy incidence in men with asthenospermia. Methods A clinical trial was performed. Fifty men with asthenospermia were included to receive placebo （control group, n=9） or T undecanoate 80 mg/d （study group, n=41）. Pregnancy incidence and sperm characteristics after 1, 2 and 3 months of medication and 3 months after the end of the trial were measured. Results Compared with the placebo, T undecanoate treatment produced a satisfactory improvement of seminal motility （F=55.904, P=0.000）. In study group, the incidence of pregnancy was 28.2% while the incidence of pregnancy in control group was 11.1%. In study group, 26patients took T undecanoate for more than 3 months. In the 3 months, semen volume showed no statistical difference （F=1.206, P=0.312） before and after treatment, sperm concentration （F=0.023, P=0.000） and motility a, b, a ＋b （P=0.000） showed statistical differences. Motility grade a showed significantly higher increment in 2 and 3 months after treatment than 1 month and there was no statistical difference between 2 and 3 months. So did grade b. Conclusion The results indicate that T undecanoate increases semjnal motility, leading to a higher incidence of pregnancy in couples with infertility related to asthenoaspermia.

关键词： testosterone undecanoate sperm motility asthenospermia

More than eight years＇ hands-on experience with the novel long-acting parenteral testosterone undecanoate

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Asian Journal of Andrology 2007年第3期9卷 291-297页

作者： Farid Saad Axel Kamischke Aksam Yassin Michael Zitzmann Markus Schubert Ffiedrich Jockenhovel HermannM. Behre Louis Gooren Eberhard Nieschlag Bayer-Schering Department of Men＇s Health Berlin Germany Gulf Medical College School of Medicine Ajman United Arab Emirates Institute of Reproductive Medicine of the University of Munster Munster Germany Department of Urology Segeberger Kliniken Norderstedt Germany Innere Medizin Klinikum der Universitiit zu Koln Koln Germany Evangelisches Krankenhaus Herne Herne Germany Andrology Unit Department of Urology Martin-Luther UniversitT Halle Germany Department of Endocrinology Andrology Section Vrije Universiteit Medical Center Amsterdam the Netherlands

testosterone （T） as a compound for treatment of T deficiency has been available for almost 70 years, but the pharmaceutical formulations have been less than ideal. Traditionally, injectable T esters have been used for treatment, but they generate supranormal T levels shortly after the 2-3 weekly injection interval. T levels then decline very rapidly, becoming subnormal during the days preceding the next injection. The rapid fluctuations in plasma T are subjectively experienced as disagreeable. T undecanoate （TU） is a new injectable T preparation with a considerably better pharmacokinetic profile. After two initial injections separated by a 6-week interval, the following intervals between two injections are generally 12 weeks, eventually amounting to a total of four injections per year. Plasma T levels with this preparation are nearly always in the range of normal men, as are its metabolic products estradiol and dihydrotestosterone （DHT）. It reverses the effects of hypogonadism on bone and muscle and metabolic parameters, and on sex functions. It is suitable for male contraception. Its safety profile is excellent because of the continuous normalcy of plasma T levels. No polycythemia has been observed and no adverse effects on lipid profiles. Prostate safety parameters are well within reference limits. TU is a valuable treatment option of androgen deficiency.

关键词： testosterone treatment testosterone undecanoate pharmacokinetic profile clinical efficacy side effects sexual dysfunction male contraception

Exploring the efficacy of testosterone undecanoate in male children with 5α-reductase deficiency

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Pediatric Investigation 2021年第4期5卷 249-254页

作者： Ying Liu Lijun Fan Xiaoling Wang Chunxiu Gong Department of Pharmacy Beijing Children’s HospitalCapital Medical UniversityNational Center for Children’s HealthBeijingChina Department of Endocrinology Genetics and MetabolismBeijing Children’s HospitalCapital Medical UniversityNational Center for Children’s HealthBeijingChina

Importance:Children with 5-alpha-reductase deficiency(5α-RD)and hypospadias present with micropenis,which makes it difficult to obtain sufficient tissue for urethral ***:We investigated the therapeutic effects of oral testosterone undecanoate and established a standard androgen treatment protocol for patients with 5α-RD with ***:Patients with 5α-RD were treated with oral testosterone undecanoate for 3 months as a *** patients were treated with no more than 3 *** the penile length(PL)reached 2.5 cm(the minimum criterion for surgery)or greater than or equal to−2.5 standard deviations(SDs)(lower limit of normal),testosterone undecanoate was considered to be ***:The median age of 90 patients with 5α-RD was 1.7 years(0.9,3.1 years).The baseline PL was 1.9±0.6 cm before *** the end of the first course,the PL of 63 patients(70%)reached 2.5 cm,and 49 patients(54%)reached greater than or equal to−2.5 *** two treatment courses,the PL of 81 patients(90%)reached 2.5 cm,and 90 patients(100%)reached greater than or equal to−2.5 *** three courses,the PL of all patients reached 2.5 cm,and all patients reached a PL greater than or equal to−2.5 *** abnormal increase was observed in height-SD score,weight-SD score,or ratio of bone age to chronological age during the 1-3-year ***:After 3-9 months of treatment,PL increased to the target *** severe adverse reactions were observed during *** undecanoate was safe and effective in children with 5α-RD with micropenis.

关键词： 5α-reductase deficiency Micropenis testosterone undecanoate Treatment Penile

Effect of combined use of Chinese-made implants and testosterone undecanoate on pituary-gonadal axis in Chinese men

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Asian Journal of Andrology 2001年第2期 158-158页

作者： Chang-Hai HE Cui-Hong LIN W. J. Bremner You-Lun GUI La-Mei LI Er-Sheng GAO Shanghai Institute of Planned Parenthood Research,Shanghai 200032,China Fudan University Medical College,Shanghai 200032,China Dept.of Medicine,Washington University,USA

Aim: To study the effect of the title drugs on the serum FSH, LH andtestosterone (T) levels in Chinese men in a contraceptive trial. Methods:Sixteen male volunteers were administered Chinese-made implant (tworods, each containing 75 mg of levonorgestrel, LNG) plus testosterone un-decanoate (TU) (250 mg, i.m. monthly for3 months). FSH, LH and Tlevels were determined with RIA. Results: The serum FSH and LH lev-els declined after the insertion of implants. They declined further after the1st TU injection and one week later, both FSH and LH levels reached thelowest levels, after which, they rose slightly. The profiles of serum LH andFSH levels after the 2nd and 3rd TU injection were similar to that followingthe 1st TU injection. After insertion of the implants, the serum T levels alsodeclined. However, after the 1st dose of TU, the T levels increased, oneweek later they reached the peak level, and then declined again. The pro-files of serum T levels after the 2nd and 3rd TU injection were also similarto that

关键词： levonorgestrel implant testosterone undecanoate male contraception

testosterone therapy reduces hepatic steatosis in men with type 2 diabetes and low serum testosterone concentrations

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World Journal of Hepatology 2022年第4期14卷 754-765页

作者： Ross Apostolov Emily Gianatti Darren Wong Numan Kutaiba Paul Gow Mathis Grossmann Marie Sinclair Department of Gastroenterology and Liver Transplant Unit Austin HealthHeidelberg 3084VICAustralia Department of Medicine University of MelbourneParkville 3010VICAustralia Department of Endocrinology Fiona Stanley HospitalMurdoch 6150WAAustralia Department of Radiology Austin HealthHeidelberg 3084VICAustralia Department of Endocrinology Austin HealthHeidelberg 3084VICAustralia

BACKGROUND Non-alcoholic fatty liver disease(NAFLD)is highly prevalent in people with diabetes with no available *** To explore the effect of testosterone treatment on *** therapy improves insulin resistance and reduces total body fat,but its impact on the liver remains poorly *** This secondary analysis of a 40 wk,randomised,double-blinded,placebocontrolled trial of intramuscular testosterone undecanoate in men with type 2 diabetes and lowered serum testosterone concentrations evaluated the change in hepatic steatosis as measured by liver fat fraction on magnetic resonance imaging(MRI).RESULTS Of 88 patients enrolled in the index study,39 had liver MRIs of whom 20 received testosterone therapy and 19 received *** patients had>5%hepatic steatosis at baseline and 38 of 39 patients met diagnostic criteria for *** liver fat at baseline was 15.0%(IQR 11.5%-21.1%)in the testosterone and 18.4%(15.0%-28.9%)in the placebo *** ALT was 34units/L(26-38)in the testosterone and 32units/L(25-52)in the placebo *** week 40,patients receiving testosterone had a median reduction in absolute liver fat of 3.5%(IQR 2.9%-6.4%)compared with an increase of 1.2%in the placebo arm(between-group difference 4.7%Ptestosterone therapy was associated with a relative reduction in liver fat of 38.3%(95%confidence interval 25.4%-49.0%,Ptestosterone therapy was associated with a reduction in hepatic steatosis in men with diabetes and low serum *** randomised studies of testosterone therapy in men with NAFLD focusing on liver-related endpoints are therefore justified.

关键词： Hepatic steatosis Non-alcoholic fatty liver disease Non-alcoholic steatohepatitis testosterone therapy testosterone undecanoate Type 2 diabetes

Inhibitine Effects of Sino-implant Plus Testosterene undecanoate(TU) on Spermatogenesis in Chinese Men

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Journal of Reproduction and Contraception 1999年第2期10卷 98-105页

作者：高尔生林翠鸿桂幼伦李腊梅贺昌海

The purpose of this study was to use a kind of safe,long acting and reversible hormonal regimen for male contraception .The studied regimen was a subdermal insertion of a two rod implant (Sino implant, each rod containing 75 mg levenorgestrel LNG) in each subject's forearm, followed 3 weeks after by monthly injection of TU (testosterone undecanoate 250 mg) for 3 months. Eighteen weeks after implantation, the Sino implant was removed. There were altogether 16 male volunteers recruited in the entire research program. Among them 6 cases reached azoospermia; one case reached oligozoospermia (sperm density <3 million/ml); 5 cases' sperm density declined greatly, the lowest to be 5.7±1.3 million/ml; the other four cases' sperm density also declined, but remained within normal range (above 20 million/ml), the lowest to be 24.5±9.0 million/ml. The duration to reach azoospermia was 16.7±0.5 weeks. The duration to resume to normal range of sperm density was 8.2±2.5 weeks in the subjects with azoospermia and oligozoospermia. In the first two weeks after insertion the LNG release of Sino implant's mean serum LNG level was about 0.38 ng/ml, in the rest of the time the LNG levels in blood was rather constant about 0.24 ng/ml. Routine analyses of blood and urine, liver and kidney functions, and blood chemistry including those parameters (TG,TC,HDL C,LDL C) of lipid metabolism didn't change much throughout the research. All the subjects' libido and sex function were well kept. Clinical observation didn't show any other adverse effects during the research.

关键词： Sino implant testosterone undecanoate Male contraception