India has finished clinical trials for the first injectable male contraceptive in the world

 India has finished clinical trials for the first injectable male contraceptive in the world

The results of the phase-III clinical study, in which 303 individuals between the ages of 25 and 40 participated, were released last month in the worldwide open access Andrology journal.

The world's first injectable male contraception has undergone clinical testing by the Indian Council of Medical Research (ICMR), which has concluded that it is safe and extremely effective with no negative side effects.

The results of the phase-III clinical study, in which 303 individuals between the ages of 25 and 40 participated, were released last month in the worldwide open access Andrology journal.

The phase-III open-label, non-randomized clinical trials were conducted at five separate centers (New Delhi, Udhampur, Ludhiana, Jaipur, and Kharagpur) under the direction of the ICMR, New Delhi.  The Drugs Controller General of India (DCGI) gave the go-ahead for the phase-III clinical study, and the individual centers' institutional ethics committees gave their seal of approval.

In order to conduct the research, it was necessary to identify 303 healthy, sexually active, married males who had vasectomy or No Scalpel Vasectomy (NSV) procedures, as well as their healthy, sexually active spouses.  The males received a 60 mg injection of RISUG (Reversible Inhibition of Sperm under Guidance).

"The overall efficacy of RISUG with regard to achieving azoospermia was 97.3 per cent with a focus on pregnancy prevention was 99.02 per cent absent any serious side effect," according to the research.

As they were on the verge of being introduced into a mass contraception program, RISUG has the greatest efficacy in the history of contraceptive development when compared to all other contraceptives, both male and female, it added.

The report claims that there is a pressing need to create contemporary male contraceptive techniques in order to decrease population growth due to the world's population growth.

Although vasectomy is a very efficient contraceptive treatment, there are several significant drawbacks that need the development of other methods. An ideal male contraceptive method would feature a one-time injection, a minimally intrusive drug delivery device, long-term efficacy with hardly perceptible side effects, and the possibility of reversal.

Reversible Inhibition of Sperm under Guidance (RISUG), a new male contraceptive strategy, has been developed to help accomplish these objectives. It has the potential to be widely used as an injectable and reversible male contraceptive treatment. In contrast to hormonal injectable contraceptives, this approach has important characteristics including limited injection and no apparent contact with other body areas, according to the research.