India Breaks Ground With World's 1st Male Contraceptive Clinical Trial

The Indian Council of Medical Research (ICMR) has achieved a significant milestone in the world of reproductive health by completing clinical trials for the world's first injectable male contraceptive. This groundbreaking development not only demonstrates its safety but also its high efficacy without any serious side effects.

The findings of this phase-III clinical trial, involving 303 candidates aged 25-40 years, have been published in the international open-access Andrology journal, marking a historic moment in the field of contraception.

The phase-III clinical trials were open-labeled and non-randomized, and conducted at five different centers - New Delhi, Udhampur, Ludhiana, Jaipur, and Kharagpur. This massive undertaking was coordinated by the ICMR, New Delhi, and made possible with gracious permission from the Drugs Controller General India (DCGI) and the approval of the institutional ethical committees of the respective centres. This collaboration underlines the significance and trust vested in this pioneering research.

A New Chapter in Contraceptive Development

As part of this groundbreaking study, 303 healthy, sexually active and married men, and their healthy, sexually active wives, who had come to the family planning clinic and department of urology or surgery for vasectomy or No Scalpel Vasectomy (NSV), were identified. These courageous men were administered with 60 mg of Reversible Inhibition of Sperm under Guidance (RISUG).

The overall efficacy of RISUG in achieving azoospermia stood at an impressive 97.3 percent. Moreover, in terms of pregnancy prevention, the efficacy soared to 99.02 percent, all while remaining devoid of serious side effects.

This achievement marks a watershed moment in the history of contraceptive development. RISUG stands out as the most effective contraceptive method, surpassing both male and female alternatives. It is poised to become a vital component of mass contraception programs due to its unparalleled effectiveness.

Addressing the Global Need

With the world's population on the rise, there is an urgent need to develop modern methods of male contraception for effective population control. While vasectomy has proven to be an effective method, it does come with some limitations. The ideal male contraceptive approach should be minimally invasive, have a one-time injection, provide long-term effectiveness, and offer the option of reversal.

The RISUG Approach

RISUG embodies these qualities, offering a novel male contraceptive approach that addresses the shortcomings of current methods. It has the potential to become a widely used, injectable, and reversible male contraceptive method. Notably, this approach features localized injection and poses no detectable interaction with other parts of the body, distinguishing it from hormonal injectable contraceptives.

The successful completion of clinical trials for the world's first injectable male contraceptive marks a momentous stride in the realm of contraception. With its exceptional effectiveness and potential for mass use, RISUG promises a brighter and more convenient future for male contraception. As the world faces population challenges, this revolutionary innovation offers hope for a balanced and controlled tomorrow.

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