World's first injectable male contraceptive clinical trials

In a remarkable advancement in contraceptive research, the Indian Council of Medical Research (ICMR) has successfully completed clinical trials for the world's first injectable male contraceptive. These trials have confirmed its safety and impressive effectiveness, without any notable side effects.

This crucial phase-3 trial involved a total of 303 participants, with ages ranging from 25 to 40 years. The comprehensive results of the ICMR clinical trials were recently published in the Andrology journal, a globally accessible publication. These trials were meticulously coordinated by the ICMR, New Delhi, and conducted across five diverse locations in India, namely New Delhi, Udhampur, Ludhiana, Jaipur, and Kharagpur.

This open-label, non-randomized, multi-centre hospital-based phase-III trial began after obtaining proper authorization from the Drugs Controller General India (DCGI). It also received approval from the institutional ethical committees of the respective centres.

The study conducted by the ICMR focused on injectable male contraceptives and included 303 men who were in good health, sexually active, and married, as well as their healthy, sexually active spouses. These couples were selected for the trials after visiting the family planning clinic, and the departments of urology or surgery for vasectomy or No Scalpel Vasectomy (NSV) were identified for their participation.

ICMR

During the trials, the male participants were administered a dose of 60 mg of Reversible Inhibition of Sperm Under Guidance (RISUG).

Based on the study findings, there is an increasing need for contemporary male contraception methods to effectively manage global population growth.

The results from the ICMR trials indicate that the RISUG method has shown remarkable effectiveness when compared to other contraceptives, benefiting both males and females.

According to the study, RISUG demonstrated a high level of effectiveness in achieving azoospermia, with an overall rate of 97.3 per cent. In terms of preventing pregnancy, it showed a success rate of 99.02 per cent, with no noteworthy side effects. “In the annals of advances in contraception, RISUG is emerging as the most effective option for both men and women and is poised for widespread integration into mass contraception programs,” it continued.

Although vasectomy is a highly effective contraceptive method, the study highlights the potential of RISUG as a male contraceptive option that can be injected and easily reversed. This method is particularly suitable for widespread use. One notable advantage is its localized injection, which does not interfere with other bodily systems like hormonal injectable contraceptives do.