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Table 2 Clinical journey of RISUG®

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

 No. of SubjectsDose regimenSperm count (million/ml)RemarksReferences
Phase I385 mg to 140 mgFor 60–140 mg dose azoospermia was reported during 20–389 days post injectionPhase 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 II1260 mgAll subjects were azoospermic within 5–243 daysThe 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 III31560 mgAfter 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]