A clinical trial of injectable testosterone undecanoate as a potential male contraceptive in normal Chinese men.
This is a pilot dose-finding study of spermatogenic suppression using testosterone undecanoate (TU) injections alone in normal Chinese men. Thirty-two healthy men were recruited. Volunteers underwent pretreatment evaluation, then a treatment period in which group I (n = 13) received 500 mg TU, group II (n = 12) received 1000 mg TU, and group III (n = 7) received placebo, respectively, at monthly intervals during the treatment period (or until azoospermia was achieved). Thereafter, they underwent a recovery period until all parameters returned to pretreatment levels. Eleven of 12 volunteers in the 500-mg TU group, and all volunteers in the 1000-mg TU group became azoospermic. Faster suppression of spermatogenesis was achieved in the 1000-mg TU group. Serum testosterone increased significantly in the higher dose group at weeks 8 and 12, but remained within the normal range. Mean serum LH and FSH were profoundly suppressed by both doses to undetectable levels at week 16. TU injections did not cause a significant change in high density lipoprotein cholesterol levels. No serious side-effects were found. We conclude that both dosages of TU can effectively, safely, and reversibly suppress spermatogenesis in normal Chinese men.
Zhang
G Y
GY
Department of Endocrinology, National Research Institute for Family Planning, Beijing, China.
Gu
Y Q
YQ
Wang
X H
XH
Cui
Y G
YG
Bremner
W J
WJ
D000328:Adult; D044466:Asian People; D001835:Body Weight / Q000187:drug effects; D003272:Contraceptive Agents, Male / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D012739:Gonadal Steroid Hormones / Q000097:blood; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007267:Injections; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D009929:Organ Size / Q000187:drug effects; D010865:Pilot Projects; D012016:Reference Values; D013076:Sperm Count / Q000187:drug effects; D013737:Testis / Q000033:anatomy & histology; D013739:Testosterone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology
D003272:Contraceptive Agents, Male; D012739:Gonadal Steroid Hormones; D006454:Hemoglobins; D008055:Lipids; D013739:Testosterone; C010792:testosterone undecanoate