Phase III of the clinical trials of Reversible Inhibition of Sperm Under Guidance, (RISUG), an indigenously developed intra-vasal injectible contraceptive for males has been extended to six more Indian states this year, a senior official said Wednesday. The trials had commenced in four states last year.
The contraceptive developed by S.K. Guha of the Indian Institute of Technology, New Delhi, as an alternative for non-scalpel vasectomy (which men hesitate to undergo) has been tested successfully on primates, Deputy Director-General of Indian Council of Medical Research (ICMR) R.S. Sharma told reporters in the southern Indian state of Tamil Nadu.
RISUG works by an injection into the vas deferens, the vessel through which the sperm moves before ejaculation. In a matter of minutes, the injection coats the walls of the vas with a clear gel prepared through irradiation.
Dr.Guha says it works, is non-surgical, and is long-lasting, a single 60 mg injection can be effective for at least ten years. It is convenient one doesn't have to run around to looking for contraceptives when in the throes of passion and has few side effects.
It is also reversible, the vas deferencs can be flushed.
In October 2002, India's Ministry of Health aborted the clinical trials due to reports of albumin in urine and scrotal swelling in Phase III trial participants.
The ICMR noted that dimethyl sulfoxide used as a solvent for the injection is known to cause kidney damage. Although the ICMR has reviewed and approved the toxicology data three times, some United States researchers say that the studies were not done according to recent international standards.
RISUG was resubmitted for a new round of tests at a US lab, and was approved as non-mutagenic in July 2005. With this new stamp of approval, the path to continued Phase III trials in India became clear.
In March 2006, the ICMR announced that Phase III trials of RISUG could resume at 4 centers around India. But there were complaints that research centers did not have enough of the RISUG compound to move forward with the trial.
Apparently the matter has been sorted out and hence the move to extend the trials.
The ICMR, said Dr. Sharma, has also formed a task force to study 'hazards of environmental pollution and changing lifestyle on human reproduction' against the backdrop of the drop in fertility levels worldwide.
The study would provide data on the extent of the prevalence of infertility in India, he said, explaining that use of banned pesticides and late marriages were among the major causes.
As advised by the Union Health Minister Anbumani Ramadoss, the ICMR would study the impact of mobile phone usage on human health.
The protocol being developed would assess the impact of radio frequency variations due to use of mobile phones on reproductive, cardiovascular, immunological, neurological and cell cycle systems of human body, he said.