The first male contraceptive which is not a condom but an injection to be renewed every 13 years could be available on the market within six months. An Indian pharmaceutical laboratory has just announced that it has developed it.
Promised and hoped for for years, is contraception for men about to see the light of day? While clinical trials on the famous male pill are multiplying without the latter ever seeing the light of day, the first contraception for men will certainly take the form of an injection.
This is revealed by the British daily The Independentwhich relays information from Hindustan Times. Indian researchers have just developed the first contraceptive injection for men. After successful clinical trials, the contraceptive was sent to the Drug Controller General of India for final marketing approval. “The product is ready, with only regulatory approvals pending with the Drug Controller,” said Dr RS Sharma, senior scientist at the Indian Council of Medical Research.
If this gives the green light, the contraceptive injection could appear on the Indian market, then the world market, by the end of the first half of 2020.
“Trials are complete, including extended phase 3 clinical trials for which 303 candidates have been recruited with a 97.3% success rate and no reported side effects. This product can be considered the world’s first male contraceptive,” Dr. Sharma said.
An injection that inhibits sperm production
If the product soon to be marketed is presented as innovative, the polymer it contains was actually developed in the 1970s. Called Steryene Maleic Anhydride and injected directly into the testicles, it inhibits sperm production for thirteen years , before gradually losing its effectiveness.
Other rigorous tests are however necessary before any marketing approval. “It’s a first in the world for India, so we have to be very careful with the approval. We are looking at all aspects especially the Good Manufacturing Practices (GMP) certification which will not raise any question as to its quality,” said VG Somani, the Comptroller General of Medicines of India.
“It will take another six to seven months for all approvals to be granted before the product can be manufactured,” he added.
If the injection is approved, it will become the first male contraceptive since the condom. It could thus become a long-term alternative to vasectomy and, in the shorter term, to contraceptives such as the pill, the implant or the IUD, the responsibility for taking of which lies solely with women.
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