|The injectable male contraceptive is designed to replace vasectomy as a new birth control method for men. / KiattisakCh via Shutterstock|
The world's first injectable male contraceptive may soon hit the shelves as the Indian Council of Medical Research (ICMR) successfully completes the clinical trials. It is designed to replace vasectomy as a new birth control method for men and its efficacy can last up to 13 years. Researchers involved in the project said the contraceptive has been sent to the Drug Controller General India (DCGI) for approval.
World’s First Male Contraceptive
Unlike a similar contraceptive under development in the US, the ICMR product is ready to go and only needs regular approvals from the DCGI. The researchers said they have completed all the trials, including extended phase 3 clinical trials that involved 303 candidates.
"The product can safely be called the world’s first male contraceptive," trial leader RS Sharma, a senior scientist with ICMR, told the Hindustan Times. Their trials showed a 97.3% success rate for the injectable contraceptive and no reported side effects. The Hindustan Times is an India-based English-language daily newspaper that provides exclusive top stories in politics, business, and technology.
It added that the contraceptive is an injectable polymer along with anesthesia in the vas deferens (the tube near the testicles that hold the sperm). Sharma said the polymer was developed in the 1970s and was researched to turn into a product for mass use.
The final product, which comes after research began in 1984, is known as reversible inhibition of sperm under guidance (RISUG) made up of a polymer compound called styrene maleic anhydride. It can last up to 13 years once injected and could also be used as an effective spacing method as soon as human studies with the product begin.
"It’s the first in the world from India so we have to be extra careful about approval," said VG Somani, the drug controller general of India. "We are looking at all aspects, especially the good manufacturing practice (GMP) certification that won’t raise any questions about its quality."
Sonami added that the approval may be granted in about six to seven months, after which manufacturing for the product can begin.
A Better Choice Over Vasectomy
The injectable male contraceptive may soon replace vasectomy as the most effective mode of birth control today. While vasectomy is less expensive and has fewer complications compared to female sterilization, only 2% (16 million) of men around the world have undergone such a procedure. That's a huge gap from condom use in men (21%), as per data from the UN's 2019 contraceptive use report.
The prevalence of this method also declined from 3.0% in 1994 to 0.8% in 2019. In the US, most men don't opt for sterilization and often rely on their female partners. A number of factors could be at play as to why this is so, the New York Times reported. This includes cost, misconceptions, and fears about the procedure as well as cultural expectations on men.
Expensive costs of vasectomy reversals are also seen as another factor, considering that it isn't covered by insurance in the US compared to insurance companies being mandated to cover 18 types of contraception in women including sterilization surgery, the New York Times added.
Anuj Khattar, a fellow with Physicians for Reproductive Health, said part of the fears for male sterilization is that it's so permanent that some men are worried about "losing some of their virility and their ability to enjoy sex."
This led experts to believe that the injectable contraceptive will surpass vasectomy as the go-to birth control for men.
"Non-surgical procedures are always preferred over surgical procedures because they will be safer and less invasive," said Anup Kumar, head of urology and renal transplant department at Safdarjung Hospital. He added that this could drive the preference for the injectable male contraceptive over vasectomy.
|Even though vasectomy is less expensive compared to female sterilization, only 2% of men around the world have undergone such procedure / Photo by: Lemau Studio via Shutterstock|
Other Contraceptives for Men
Aside from the injectable polymer contraceptive, a birth control pill for men is also under development. Live Science, a science news website that features groundbreaking developments in science, space, technology, health, the environment, our culture, and history, reported earlier this year that a team of scientists has announced that the pill has passed human safety tests without any major side effect.
Side effects that come with other male birth control attempts included lowering the men's sex drive or health problems due to the modified hormone levels. A hormone known as progestin creates this effect in which it decreases natural testosterone levels that may lead to blood clots, depression, and other health issues.
But the new pill, which is paired with modified testosterone, allows the molecule to keep sperm count low while ensuring that the modified sex hormone fulfills its essential roles.
Live Science noted that the trial merely evaluated the safety of the drug and its effectiveness (given that it would take 60 to 90 days for sperm counts to decrease).
Some of the minor side effects that came with taking pills were acne, headaches, lower sex drive, mild erectile dysfunction or tiredness as well as an average weight gain of 2.8 to 4.2 lbs., depending on the dose. Long-term side effects also remain unclear.
Still, the development of this new kind of contraceptive methods is welcome as it would allow men to be directly involved in family planning and preventing unwanted pregnancies and not just put all the burden on women.