Team Blitz India
NEW DELHI: The Indian Council of Medical Research (ICMR) has completed the clinical trials of the world’s first injectable male contraceptive which showed that it is safe and highly efficacious without any serious side effects.
The findings of the phase-III clinical trial, which involved 303 candidates aged 25-40 years, were published in the international open access Andrology journal last month.
The open-labelled and non-randomized, multi-centre hospital-based phase-III clinical trials were carried out at five different centres (New Delhi, Udhampur, Ludhiana, Jaipur and Kharagpur) and coordinated by the ICMR.
The permission to conduct phase-III clinical trial was granted by the Drugs Controller General India (DCGI) and approved by the institutional ethical committees of the respective centres.
As part of the study, 303 healthy, sexually active and married men and their healthy and sexually active wives who came to the family planning clinic and department of urology or surgery for vasectomy or No Scalpel Vasectomy (NSV) were identified.
The men were injected with 60 mg of Reversible Inhibition of Sperm under Guidance (RISUG).
