New Delhi: The Indian Council of Medical Research (ICMR) has successfully concluded clinical trials for the world's first injectable male contraceptive. The results indicate that this innovative contraceptive is not only safe but also highly effective, with minimal side effects.

The phase-III clinical trial, which included 303 participants aged 25-40 years, recently published its findings in the international open-access Andrology journal. The trials, coordinated by the ICMR in New Delhi, were conducted at five different centers across India, including New Delhi, Udhampur, Ludhiana, Jaipur, and Kharagpur. The trials were open-labeled, non-randomized, and hospital-based, with approval from the Drugs Controller General India (DCGI) and the institutional ethical committees of the respective centers.

In this study, 303 healthy, sexually active, married men, and their wives who sought family planning services or vasectomy at the family planning clinic and the departments of urology or surgery participated. These men received a 60 mg injection of Reversible Inhibition of Sperm under Guidance (RISUG).

The study's findings revealed that RISUG achieved a remarkable 97.3% effectiveness in causing azoospermia, rendering the participants non-fertile. It also demonstrated a 99.02% success rate in preventing pregnancy, all while exhibiting minimal side effects.

The study highlighted the significance of RISUG in the history of contraceptive development, as it presents the highest level of effectiveness when compared to other male and female contraceptives. The researchers noted that RISUG could soon become a part of mass contraception programs.

Given the global population's steady growth, there is an urgent need to develop modern methods of male contraception for effective population control. Although vasectomy is an established contraceptive measure, certain limitations have prompted the search for improved techniques. An ideal male contraceptive method should offer a minimally invasive drug delivery system with a one-time injection, long-term effectiveness, minimal side effects, and the option of reversal.

"To achieve these goals, a novel male contraceptive approach known as Reversible Inhibition of Sperm under Guidance (RISUG) has been developed. It holds the potential to become a widely used, injectable, and reversible male contraceptive method. Notably, RISUG's key features include localized injection and a lack of detectable interaction with other body parts, unlike hormonal injectable contraceptives," the study concluded.

The successful development of this injectable male contraceptive represents a significant advancement in the field of contraception and family planning, offering a promising option for men in the realm of birth control.

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