Phase II clinical trial of a vas deferens injectable contraceptive for the male.
Following up on an earlier clinical trial demonstrating the safety of an intra-vas deferens injection of a contraceptive drug named Risug, comprised of styrene maleic anhydride (SMA) in a solvent vehicle of dimethylsulphoxide (DMSO), a study to assess the contraceptive effectiveness of a specific dose (60 mg) of SMA bilaterally was planned and implemented. Male subjects and their wives with normal reproductive profiles were the volunteer subjects. The wives were not using any contraceptives. The results reconfirm the safety and show that for a period of at least 1 year, the treatment leads to azoospermia in the male and gives pregnancy protection.
Guha
S K
SK
Centre for Biomedical Engineering, Indian Institute of Technology and All India Institute of Medical Sciences, New Delhi, India. guhask@giasd101.vsnl.net.in
Singh
G
G
Ansari
S
S
Kumar
S
S
Srivastava
A
A
Koul
V
V
Das
H C
HC
Malhotra
R L
RL
Das
S K
SK
D000328:Adult; D003272:Contraceptive Agents, Male / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007267:Injections / Q000379:methods; D008297:Male; D008299:Maleic Anhydrides / Q000008:administration & dosage*; D009845:Oligospermia; D011137:Polystyrenes / Q000008:administration & dosage*; D013094:Spermatozoa / Q000187:drug effects*; D014649:Vas Deferens
D003272:Contraceptive Agents, Male; D008299:Maleic Anhydrides; D011137:Polystyrenes; C025704:Styromal