The world’s first contraceptive injection for men could be available for consumer use within six months, after Indian scientists announced that clinical trials have been completed on the drug.
The contraceptive, which remains effective for 13 years before it loses potency, has been sent to the national Drug Controller General of India for final approval.
“The product is ready, with only regulatory approvals pending with the Drugs Controller,” said Dr RS Sharma, senior scientist with Indian Council of Medical Research, in a comment to the Hindustan Times.
“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.”
The contraceptive works via an injection to a sperm-containing tube near the testicles.
It contains a polymer called Steryene Maleic Anhydride developed in the 1970s that inhibits sperm production.
If approved, the injection will be the first male contraceptive offered to consumers in the world, although it will be marketed as a long-term alternative to a vasectomy, rather than a short-term option like the implant or coil that are on offer to women.
However rigorous testing means it won’t be available for another six months, minimum.
“It’s the first in the world from India so we have to be extra careful about approval. We are looking at all aspects, especially the good manufacturing practice (GMP) certification that won’t raise any questions about its quality,” said VG Somani, the Drug Controller General of India.
“It will still take about six to seven months for all the approvals to be granted before the product can be manufactured.”
The rate of development of male contraceptives has increased in recent years; in January year-long tests began on a contraceptive gel that reduces sperm count to zero, with eighty British men taking part in the trial.
However, sterilisation remains the only approved method of contraception for men in the world, despite the oral contraceptive pill for women being approved for public usage in 1960.