New Delhi: The Indian Council of Medical Research (ICMR) has completed clinical trials of the world’s first injectable contraceptive for males that provides long-lasting sterility with complete reversibility, new agency PTI reported on Thursday.
The findings of the phase-III clinical trial, involving 303 candidates aged 25-40 years, were published in the international open access Andrology journal last month. The seven-year follow up of the candidates showed that the non-hormonal injectable male contraceptive RISUG (Reversible Inhibition of Sperm under Guidance) is safe and highly efficacious without any serious side effects.
The open-labelled and non-randomized, multi-centre hospital-based phase-III clinical trials were carried out at five different centres (New Delhi, Udhampur, Ludhiana, Jaipur and Kharagpur) and coordinated by the ICMR, New Delhi. The men were injected with 60 mg of RISUG. “The overall efficacy of RISUG with respect to achieving azoospermia was 97.3 per cent and based on pregnancy prevention was 99.02 per cent without any serious side effect,” the study stated.
The product is made of a compound called Styrene Maleic Anhydride. “Significant features of this method include localized injection and no detectable interaction with other body parts unlike the hormonal injectable contraceptives,” the study added.
According to reports, the contraceptive will be effective for 13 years, after which it loses its potency. It would replace surgical vasectomy, which is the only male sterilisation method available in the world.
