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) | 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. |