PHASE-I CLINICAL-TRIAL OF AN INJECTABLE CONTRACEPTIVE FOR THE MALE

被引:52
作者
GUHA, SK
SINGH, G
ANAND, S
ANSARI, S
KUMAR, S
KOUL, V
机构
[1] ALL INDIA INST MED SCI,NEW DELHI 110029,DELHI,INDIA
[2] LNJP HOSP,DEPT SURG,NEW DELHI 110002,DELHI,INDIA
关键词
MALE; CONTRACEPTIVE; INJECTABLE; CLINICAL TRIAL; POLYMER; PH; STYRENE MALEIC ANHYDRIDE;
D O I
10.1016/0010-7824(93)90082-I
中图分类号
R71 [妇产科学];
学科分类号
100211 [妇产科学];
摘要
Earlier studies on the rat and the monkey had demonstrated that an injection of styrene maleic anhydride (SMA) in a solvent vehicle of dimethyl sulphoxide (DMSO) into the lumen of the vas deferens is toxicologically safe and has contraceptive action. Phase I clinical trial was therefore undertaken on 38 male volunteers giving varying doses of SMA, ranging between 5 mg and 140 mg, into each vas deferens. A dose of 70 mg is the predicted therapeutic dose based on animal data. That the compound is within the vas deferens lumen during the period of the safety assessment is inferred from the effect on the spermatozoa count in ejaculates which reach azoospermic levels in the higher dose ranges. The treatment is well tolerated with only minimal side effects in a few cases and no long-term adverse effects.
引用
收藏
页码:367 / 375
页数:9
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