World's First Injectable Male Contraceptive Found Effective in ICMR Clinical Trials
In a groundbreaking move, the Indian Council of Medical Research (ICMR) has completed clinical trials of the world”s first injectable male contraceptive. The trials have demonstrated high efficacy and safety, with no reported side effects. If successfully brought into use, this method could be a game-changer in the field of contraception and birth control.
The Phase-3 clinical trial was conducted on 303 men aged 25-40. The results were published in the international open access journal Andrology last month.
The trials were conducted at five different locations in India, led by the ICMR in New Delhi. The other sites were Udhampur, Ludhiana, Jaipur, and Kharagpur. The ICMR had received approval from the Drugs Controller General of India (DCGI) to conduct the trials.
The trials included 303 healthy, sexually active married men and their healthy, sexually active wives. These couples were recruited from family planning clinics and departments of urology or surgery, where they had been considering vasectomy or no-scalpel vasectomy (NSV).
During the trials, the men were injected with 60 mg of a substance called Reversible Inhibition of Sperm Under Guidance (RISUG). The ICMR conducted the third trial in response to India”s population boom and the urgent need for modern methods of male contraception for population control.
The ICMR trials showed that the RISUG method was more effective than all other male and female contraceptives.
“The overall efficacy of RISUG with respect to achieving azoospermia (absence of sperm in the ejaculate) was 97.3%, and based on pregnancy prevention was 99.02%, 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,” the study said. “RISUG is on the threshold of being introduced into a mass contraception program.”
While vasectomy is considered a highly effective contraceptive measure, it is a permanent procedure. RISUG offers the advantage of being reversible.
“To achieve these goals, a novel male contraceptive approach of Reversible Inhibition of Sperm Under Guidance (RISUG) has been developed,” the study said. “RISUG has the potential to become a mass-use injectable and reversible male contraceptive method. Significant features of this method include localized injection and no detectable interaction with other body parts, unlike hormonal injectable contraceptives.”
The successful completion of clinical trials for RISUG is a major breakthrough in the field of contraception. If approved for use, RISUG could provide a safe and effective option for men who are seeking a reversible method of birth control.
