The world’s first male injectable male contraceptive has successfully passed clinical trials in India, and could take six to seven months before the product becomes available for mass production.
The product, which was developed by the Indian Council of Medical Research (ICMR) and is called Reversible Inhibition of Sperm Under Guidance (RISUG), has been sent to the Drug Controller General of India (DCGI) for approval, according to Hindustan Times.
“The product is ready, with only regulatory approvals pending with the Drugs Controller,” says Dr. R.S. Sharma, a senior scientist with ICMR and head researcher in the trial.
“The trials are over, including extended, phase 3 clinical trials for which 303 candidates were recruited with 97.3% success rate and no reported side-effects. The product can safely be called the world’s first male contraceptive.”
RISUG, a polymer contraceptive that was developed in 1970 and has been in research since 1984, is made of a compound called Styrene Maleic Anhydride. It has a lasting effect of up to 13 years before the effect starts to wear off.
“In clinical studies on mice, it has been proven to be a reliable spacing method, and we will be initiating human studies soon to prove that in humans also, it can be used as an effective spacing method,” Sharma said.
RISUG can be injected under local anesthesia by a registered medical professional at the sperm-containing tube near the testicles (vas deferens), The Hindustan Times reported. The polymer in the contraceptive will block the tube and prevent the sperm from passing. Currently, the only approved method for male contraception is a vasectomy, the surgical procedure that cuts, ties, or cauterized the vas deferens, according to the Mayo Clinic.
“Non-surgical procedures are always preferred over surgical procedures because they will be safer and less invasive,” says Dr. Anup Kumar, head of the urology and renal transplant department at Safdarjung Hospital in New Delhi.
A trial for an injectable male contraceptive with a success rate of 96% was stopped in 2016 after many men involved in the test suffered from side effects like acne and mood changes, according to the article published by National Health Service. In the U.S., development on a similar male contraceptive called Vasalgel is still in the development phase, according to LiveScience.