Citation

Guha SK, Singh G, Anand S, Ansari S, Kumar S, Koul V. Contraception 1993; 48(4): 367-375.

Copyright

(Copyright © 1993, Elsevier Publishing)

DOI

10.1016/0010-7824(93)90082-i

PMID

8222664

Abstract

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.

Language: en

Keywords

Adult; Asia; Biology; Clinical Research; Clinical Trials; Contraception; Contraception Research; Contraceptive Agents, Male; Developing Countries; Dimethyl Sulfoxide; Dose-Response Relationship, Drug; Examinations And Diagnoses; Family Planning; Genitalia; Genitalia, Male; Human Volunteers--men; Humans; India; Ingredients And Chemicals; Injections; Inorganic Chemicals--administraction and dosage; Laboratory Examinations And Diagnoses; Laboratory Procedures; Male; Male Sterilization; Physiology; Polymers--administraction and dosage; Research Methodology; Southern Asia; Sperm Count; Sterilization, Sexual; Styrenes; Urogenital System; Vas Deferens; Vas Occlusion; Vasectomy