In a major breakthrough in the field of contraceptive and birth control, the Indian Council of Medical Research (ICMR) completed the clinical trials of the world’s first injectable male contraceptive. The clinical trial showed that the method is safe and highly efficacious without any serious side effects.
The phase-3 of the clinical trial, involved 303 candidates aged 25-40 years. The findings of the ICMR clinical trials were published in the international open access Andrology journal last month.
The clinical trial were carried out at five different locations in the country. The centres for trials were located in New Delhi, Udhampur, Ludhiana, Jaipur, and Kharagpur, and coordinated by the ICMR, New Delhi.
The open-labelled and non-randomized, multi-centre hospital-based phase-III clinical trials were carried out after getting permission from the Drugs Controller General India (DCGI). It was approved by the institutional ethical committees of the respective centres.
About the ICMR study on injectable male contraceptives:
Under the study, a total of 303 healthy, sexually active, and married men and their healthy and sexually active wives were included. These couples were selected for the trials after they came to the family planning clinic and department of urology or surgery for vasectomy or No Scalpel Vasectomy (NSV) were identified. During the trials, men were injected with 60 mg of Reversible Inhibition of Sperm under Guidance (RISUG).
According to the study, the huge surge in world population led to an urgent need to develop modern methods of male contraception for population control.
Study findings:
The ICMR trials indicated that the RISUG method presented the highest effectiveness compared to all other contraceptives for both males and females.
“The overall efficacy of RISUG with respect to achieving azoospermia was 97.3 per cent, and based on pregnancy prevention was 99.02 per cent without any serious side effect,” 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,” it said.
However, vasectomy is considered quite effective as a contraceptive measure. “To achieve these goals, a novel male contraceptive approach of Reversible Inhibition of Sperm under Guidance (RISUG) has been developed, which has the potential to become for mass use as a once injectable and reversible male contraceptive method. Significant features of this method include localized injection and no detectable interaction with other body parts, unlike the hormonal injectable contraceptives,” the study said.
