The Indian Council of Medical Research (ICMR) has successfully concluded clinical trials for the world’s first injectable male contraceptive. The trials demonstrated its safety and high efficacy, with no significant side effects reported.
The results of the phase-III clinical trial, which involved 303 participants aged 25-40 years were published last month in the international open-access journal Andrology.
The open-labelled and non-randomised, 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.
Permission to conduct phase-III clinical trials was granted by the Drugs Controller General India (DCGI) and approved by the institutional ethical committees of the respective centres.
As part of the study, 303 healthy, sexually active, and married men and their healthy and sexually active wives who came to the family planning clinic and department of urology or surgery for vasectomy or No Scalpel Vasectomy (NSV) were identified.
The men were injected with 60 mg of Reversible Inhibition of Sperm under Guidance (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.
“In the history of contraceptive development, RISUG presents the highest effectiveness compared to all other contraceptives both male and female as they were at the threshold of induction into a mass contraception programme,” it said.
According to the study, with an ever-increasing world population, there is an urgent need to develop modern methods of male contraception for population control.
Even though vasectomy is quite effective as a contraceptive measure, some major limitations of this method call for the development of improved techniques.
An ideal male contraceptive approach should have minimally invasive drug delivery system with a one-time injection, long-term effectiveness with negligible side-effects and the option of reversal.
“To achieve these goals, a novel male contraceptive approach of Reversible Inhibition of Sperm under Guidance (RISUG) has been developed, which has the potential to become for mass use as once injectable and reversible male contraceptive method.
Significant features of this method include localised injection and no detectable interaction with other body parts unlike the hormonal injectable contraceptives,” the study said.