Table 2.

Clinical journey of RISUG^®

	No. of Subjects	Dose regimen	Sperm count (million/ml)	Remarks	References
Phase I	38	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.	[50]
Phase II	12	60 mg	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.	[51]
Phase III	315	60 mg	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.	[52, 53]