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Table 2 Clinical journey of RISUG®

From: RISUG® as a male contraceptive: journey from bench to bedside


No. of Subjects

Dose regimen

Sperm count (million/ml)



Phase I


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.


Phase II


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.


Phase III


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]