Vasalgel
Vasalgel is intended to be the first long-acting, non-hormonal, reversible male contraceptive on the market.
Why male contraception?
Despite currently available contraceptives, 85 million unintended pregnancies occur annually worldwide1. Women have a number of options available, including long-acting, reversible methods. However, almost half of women in the US have discontinued use of an FDA approved method due to dissatisfaction, with side effects as the most commonly cited reason for discontinuation2.
Men currently have little choice. Vasectomy is effective but considered permanent due to the high cost and unpredictable success of reversal surgery. Condoms have the benefit of reducing disease transmission but the failure rate in typical use is high: 14-18% per year. The withdrawal method has an even higher failure rate in typical use. Despite these limitations, male methods make up 16% of contraceptive use worldwide3,4.
• Globally, over 213M pregnancies occur annually, of which 40% (85M) are unintended and 50% end in abortion1. In the US, 2.8M of the 6M annual pregnancies are unintended, with 42% terminated5.
• 68% of US unplanned births were paid for by public insurance programs, primarily Medicaid4.
• Permanent contraception is chosen by over 21% of people worldwide (18.9% tubal ligation; 2.4% vasectomy)6. In the US, 500,000 vasectomies and 700,000 bilateral tubal ligations are performed each year7.
• Temporary contraceptive methods are used by 41.4% of women worldwide8. In the US, 25M women rely on temporary methods including 43% of women who do not intend to have more children9.
Now men are demanding more. Research has shown acceptability of new male options, and Revolution Contraceptives is engaged with approximately 50,000 men and women, which supports this demand. If the method is reversible, non-hormonal, and doesn’t require daily application – even better!
For more information
1Sedgh et al., 2014. Intended and unintended pregnancies worldwide in 2012 and recent trends. Stud Fam Plann, 45:301–14.
2Moreau et al., 2007. Contraceptive discontinuation attributed to method dissatisfaction in the United States. Contraception 67:267-272.
3Ross J, Hardee K. 2017. Use of male methods of contraception worldwide. J Biosoc Sci. 49(5):648-663.
4World Health Organization. 2018. Family planning/contraception.
5Guttmacher Institute, 2016. Unintended pregnancy in the United States. Fact sheet.
6United Nations, Department of Economic and Social Affairs, Population Division. World contraceptive use 2011 wall chart.
7Barone et al., 2006. Vasectomy in the United States, 2002. J Urol,176:232-6.
8Westoff & Davis. 2000. Tubal sterilization: focus on the U.S. experience. Fertil Steril 73:913-22.
9Daniels et al., 2015. Current contraceptive use and variation by selected characteristics among women aged 15–44: United States, 2011–2013. National Health Statistics Reports, No. 86.
What is Vasalgel?
Vasalgel is a new male contraceptive currently under development. It is a polymer material that is delivered into each vas deferens (the duct that transports sperm), where it sets up as a gel to block the flow of sperm.
The procedure is similar to a no-scalpel vasectomy, except the vas deferens is not cut (as in vasectomy) — instead Vasalgel is delivered into it. The gel would be removed by flushing each vas deferens when future fertility is desired.
Recently-completed rabbit studies showed rapid restoration of sperm flow after flushing the vas deferens.
Vasalgel FAQs
Vasalgel is being developed as a polymer material that will be delivered into each vas deferens (the duct that transports sperm), where it sets up as a gel to block the flow of sperm. The quick in-office procedure will be similar to no-scalpel vasectomy except the vas is not cut, which will make reversal a simple procedure as well. This video is a representation of the process.
Vasalgel is designed to block sperm but not other seminal fluids, so it is expected to have minimal effect on ejaculation. This, of course, will be determined with human clinical testing.
We expect Vasalgel to be long-acting, but we don’t know yet how many years the effect will last. This will be determined through clinical testing.
Although Vasalgel and RISUG are based on similar concepts of using a polymer gel delivered into the vas deferens, the two polymers and their formulations are different. RISUG has been developed and tested in India over multiple decades, whereas Vasalgel has been in development in the U.S. since 2010.
The goal is to develop a reversible long-acting male contraceptive. Early preclinical studies have demonstrated rapid restoration of sperm flow after the gel was dissolved and flushed from the vas deferens.
Vasalgel will be available after clinical studies and regulatory approval are completed. For updates and news about Vasalgel, join our email list.
You can “like” Vasalgel on Facebook and follow development on Twitter, receive email update newsletters (sign up here), and visit the website of the Male Contraception Initiative advocacy organization.
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