Vasalgel FAQ’s

Vasalgel FAQ’s

Find Your Answers Here!

Vasalgel is a polymer hydrogel that is injected into the vas deferens (the tube sperm swim through) and blocks sperm. The quick procedure is similar to No-Scalpel Vasectomy (NSV), except the doctor injects the vas deferens with gel, instead of cutting it.
Vasalgel has no effect on orgasm or ejaculation, and seminal fluids will still be released (just not with sperm!).
Two common concerns regarding vasectomy are the development of sperm granulomas and pressure buildup. However, only a small percentage of men who have had a vasectomy experience chronic pain (1-2% according to the American Urological Association). Our current understanding of Vasalgel is that fluids can pass through the gel, but sperm cannot. This will likely reduce the incidence of back-pressure. Sperm granulomas are formed when the vas deferens is severed in a vasectomy and sperm leak into surrounding tissue. Since injection of Vasalgel does not involve cutting the vas deferens, this should not be an issue.
It’s “VAH-zuhl-gel” or “VAY-zuhl-gel”, your choice—even our team can’t agree! It’s named after the vas deferens.
They’re similar, but no. Although Vasalgel and RISUG® are based on the same concept of using a polymer gel injected into the vas deferens, the formulations are not the same. And RISUG has been developed and tested in India over multiple decades, while Vasalgel is being developed in the United States to conform to the latest FDA and international codes of production and safety.
Our understanding is that Vasalgel works by blocking or filtering out sperm. In the past, RISUG (a different product) was described as working by shredding sperm by an electrical charge process as they went past the contraceptive that lined the walls of the vas deferens. Vasalgel makes no such claims.
The idea is to develop a fully reversible long-acting male contraceptive, and recently-completed rabbit studies showed rapid restoration of sperm flow. This was accomplished by flushing the Vasalgel from the vas deferens with an injection of sodium bicarbonate (baking soda) solution. Additional preclinical studies are underway to further test the methods and efficacy of reversibility in larger animals. Until reversibility studies are done in men, Vasalgel should be thought of as a vasectomy alternative.
We want to get Vasalgel on the market as soon as possible, but all the proper efficacy and safety testing needs to be completed. Vasalgel is currently undergoing animal testing, product qualification and safety testing. Human trials are expected to start in 2016 (small trial) and 2017 (larger trials). If everything goes well and with enough public support, we hope to get Vasalgel on the market as early as 2018.
Vasalgel’s developer is committed to making it affordable and widely available—close to cost in low-income countries, and less than current long-acting contraceptives in the U.S.—but until the process is further along we won’t know exactly how much it will cost. It’ll have to cost enough to make the company sustainable, but the goal is for it to cost a day or two’s average wages in wealthy countries, not a week’s wages— $800 or more!—like current long-acting contraceptives (IUDs) for women in the U.S. It is likely that the cost for the doctor visit will be more than for the product. We’ll also work to get it covered by insurance.
Once it is on the market, Vasalgel will be available like vasectomy and other contraceptive options. However, reversibility evidence will be important for men who may want children in the future. Men’s sperm count declines with age, so freezing sperm as a backup is also an option for men who want to make extra sure they can have children in the future.
We don’t yet know where the first trials will be held. Sign up for the email list and we’ll let you know as soon as we know!
The first clinical trials will likely be limited to men who are okay with potential irreversibility (i.e. don’t want any more children), since the clinicians won’t be able to promise reversibility until a reversibility study is later done. For all trials, the clinicians supervising the trial will determine selection criteria and final study participants. We’d like to be able to say that the longest-time fans or earliest donors or biggest donors would get priority, but unfortunately it may not work that way—we may not have much choice in what regulators permit. Sign up for the email list to get updates as it takes shape. And donate to help us get it to market, so everybody has access!
Unfortunately not! RISUG is not yet on the market in India, and clinical trials of RISUG are only for Indian men who live near the study sites. There is a list of clinical trial sites in India on the RISUG page at NewMaleContraception.org. If you live near one of those cities in India, you might be in luck! But otherwise, Vasalgel is your best bet and we hope for your support.
Preclinical studies in rabbits were completed in late 2013 and results are being prepared for publication. It takes a while for scientific research to go through the peer review and publication process, but we anticipate publication of rabbit studies in 2016 in open-access journals. Be sure to sign up for our email list to get summaries of study results and announcements for publication availability.
Share the news about Vasalgel with friends and colleagues; “like” us on Facebook; and sign the nonprofit Male Contraception Information Project’s petition to let funders and policy-makers know that there is a demand for male contraceptives. Then stand up and be counted: Sign up as a supporter of the new Male Contraception Initiative advocacy organization. Finally, if you see any stories online with inaccuracies about Vasalgel, correcting those in the story’s comments section is an area where we could really use help!
The options aren’t great, but The Male Contraception Information Project has a description of some of the least-bad current ones, including better IUDs for women and a DIY method for men: “While you wait”.
Vasalgel is being developed as a “social venture” (designed to make enough profit to be sustainable, but not make a killing). The primary goal is to make an affordable, effective male contraceptive widely available, so there’s no opportunity for getting rich quick—this is not the next Microsoft stock! Also, our format does not allow us to sell stock on the market. However, you can donate to the venture’s nonprofit parent, Parsemus Foundation, to help keep the project afloat! You’ll find the donation link on each of Vasagel’s pages. And we are seeking socially-minded donors/investors of $50,000 or more (accredited investors and investment funds)—so if you know of anybody in that category who would like to see this succeed, please spread the word!
Big pharma experimented with repurposing its female contraceptives for male use, but has not remained interested in male contraception since that approach failed—perhaps because it is more lucrative to sell ongoing hormonal birth control to women. Big pharma already has most of the market in developed countries, and selling a method to women’s partners would cannibalize existing sales. Smaller companies are often scared off by the liability or just don’t have the money. In addition, a pure for-profit company might make the price so high as to reduce access. Vasalgel’s development is being supported by Parsemus Foundation as a “social venture” to ensure low costs and wide availability—so we have to be careful about whom we choose as partners. However, as development progresses, we will seek other social-minded organizations to help us take it to the next level.
Crowdfunding is a great idea for Vasalgel. Kickstarter says they will not accept this type of project (too medical) even though supporters petitioned, but IndieGoGo should be a better fit. So why not right away? Because crowdfunding experts have advised us to use crowdfunding to help fund human clinical trials – not preclinical work – because most folks want to support the final stages of the project. Depending on other fundraising initiatives, we may engage in crowdfunding in the future.
We expect that Vasalgel will be as effective as a vasectomy. In a one-year rabbit study, we saw no sperm, starting shortly after implantation, which is a very good sign. We have also shown effectiveness in baboons for just over a year. We don’t know yet how many years the effect will last for Vasalgel; upcoming research will help produce those answers.
It is certainly possible that Vasalgel could be used in the Fallopian tubes to block the egg from passing through on its way to the uterus. While there has been some experimental work in this area, our focus is on getting Vasalgel to market for men, since there are currently only two contraceptive options for men (vasectomy and condoms). We hope that in the future, this line of research can be followed up to result in a nonhormonal contraceptive option for women, too!
No, it’s not likely to stop the spread of HIV, since quite a bit of HIV lives in the seminal fluid and only about a third of HIV lives on the sperm. So it will be most appropriate for committed couples, or as a backup to condoms. To support research on a method that could reduce HIV transmission, check out the Clean Sheets Pill.
Regulatory agencies require a number of steps in the process of approving a new medicine or treatment, and some can only be accomplished with animal models. However, the Parsemus Foundation (which supports Vasalgel research) is also involved in animal welfare, and cannot accept current U.S. research animal care and housing standards in good conscience. Thus for studies that are absolutely required, we are working to “make change within the system” by raising the bar on animal care and showing research facilities that there is another way to do things (and that people are willing to pay for it). The foundation requires, even in the U.S., that animal studies be conducted under the strict European animal welfare standards and follow the recommendations of the UK National Centre for the Replacement, Refinement, and Reduction of Animals in Research. In addition to making their lives as comfortable as possible, animals are adopted out whenever possible. We hope to have your support in paying for these improvements! We have already seen a difference, with some facilities adopting the improvements for other animals in their facility too. It is not a perfect solution, but there is no other way to get humans a new contraceptive option. For more information, check out the Research Requirements for Animal Welfare.
Probably, but our first priority is getting Vasalgel developed for human use. In addition, since it does not change hormones, Vasalgel cannot substitute for pet neuter (hormone elimination is necessary to stop behavior such as roaming in dogs and spraying in cats). The demand would be limited to those seeking a reversible, non-behavior-changing option. However, the Parsemus Foundation (which supports the work on Vasalgel) also funds research on nonsurgical sterilization options for domestic animals – including calcium chloride, a well-studied and very affordable option for cats and dogs that is available for use now, worldwide, for about a dollar a dose. Do you work with or support spay/neuter organizations? Please spread the word about Calchlorin nonsurgical pet neuter! For hormone-sparing options for pets that are available now, see our page at Hormone-Sparing Male Sterilization.
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