In a groundbreaking development, the Indian Council of Medical Research (ICMR) has concluded clinical trials for the world's first injectable male contraceptive. The results 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 trials, which took place at five different centres (New Delhi, Udhampur, Ludhiana, Jaipur, and Kharagpur), were coordinated by the ICMR, New Delhi. The study's findings have shown that the injectable male contraceptive, known as Reversible Inhibition of Sperm under Guidance (RISUG), is safe, highly efficacious, and free from serious side effects.
The trial, conducted under an open-label, non-randomised, multi-centre hospital-based design, received approval from the Drugs Controller General India (DCGI) and the institutional ethical committees of the respective centres.
In the study, 303 healthy, sexually active, and married men, along with their spouses, were identified. These men were injected with 60 mg of RISUG, a novel male contraceptive approach.
The study's results have been remarkable, with RISUG demonstrating an overall efficacy of 97.3% in achieving azoospermia (absence of sperm in semen) and a 99.02% effectiveness in preventing pregnancies, all without any serious side effects.
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 program."
In the context of the global population surge, there has been an urgent need for modern methods of male contraception for effective population control. While vasectomy has been a reliable method, it has certain limitations that necessitate the development of improved techniques. An ideal male contraceptive should be minimally invasive, offer a one-time injection, ensure long-term effectiveness with minimal side effects, and provide the option of reversal.
RISUG addresses these criteria with its innovative approach. The method's significant features include localised injection and no detectable interaction with other body parts, distinguishing it from hormonal injectable contraceptives.
The success of these clinical trials marks a pivotal moment in the realm of contraception, offering a promising solution for family planning and population control.
This milestone achievement not only signifies a significant leap in contraceptive technology but also paves the way for a revolutionary approach to male contraception that could potentially transform global family planning strategies.