No. of Subjects
Sperm count (million/ml)
5 mg to 140 mg
For 60–140 mg dose azoospermia was reported during 20–389 days post injection
Phase I clinical trial showed that the injection of DMSO and DMSO-SMA mixture into the lumen of the vas deferens is a safe procedure with no long-term adverse effects.
All subjects were azoospermic within 5–243 days
The results of Phase II clinical trials reconfirm the safety and show that for a period of at least one year, the treatment leads to azoospermia in the male and gives pregnancy protection.
After 2.5 months 92.6% subjects and after 6 months 96.7% subjects showed azoospermia post RISUG® injection.
Contraceptive efficacy was found to be 99.02% with 0.3% method failure and 0.98% overall failure in the drug efficacy.