India has achieved a significant milestone in the field of contraception with the successful completion of clinical trials for the world's first injectable male contraceptive, as announced by the Indian Council of Medical Research (ICMR).
Led by the ICMR, the clinical trials took place across five different centers in India, including New Delhi, Udhampur, Ludhiana, Jaipur, and Kharagpur. Prior to commencing the study, the Drugs Controller General India (DCGI) granted permission, and the institutional ethical committees of the respective centers gave their approval.
The trial encompassed 303 healthy, sexually active, and married men, along with their spouses. As part of the study, the participants were administered 60 mg of the innovative Reversible Inhibition of Sperm under Guidance (RISUG), specifically developed for this research.
The results of the study revealed that RISUG demonstrated both safety and high efficacy, with no significant adverse effects reported. The male contraceptive method exhibited an impressive overall efficacy rate of 97.3 percent in achieving azoospermia, or the absence of sperm in semen. Furthermore, it demonstrated a remarkable efficacy rate of 99.02 percent in preventing pregnancy.
The phase-III clinical trial, involving 303 participants aged 25-40 years, ushers in a new era for male contraception, offering couples greater control over family planning and contributing to the ongoing global efforts in population control.
The clinical study marks a major stride forward in the realm of male contraception, holding immense promise for future population control efforts.
The development of RISUG as a male contraceptive method is of paramount significance when considering population control and the need for contemporary approaches to male contraception. This study underscores the potential of RISUG to become a widely utilized, injectable, and reversible male contraceptive method. Unlike hormonal injectable contraceptives, RISUG offers distinct advantages such as localized injection and minimal interaction with other bodily systems.
An ideal male contraceptive approach should entail a minimally invasive drug delivery system, long-term effectiveness with minimal side effects, and the option for reversal. RISUG fulfills these criteria, presenting a highly effective alternative to existing male and female contraceptive methods.
The findings of the research on this revolutionary male contraceptive have recently been published in Andrology journal.
