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 with gel, instead of cutting it.
How is Vasalgel pronounced?
It’s “VAH-zuhl-gel” or “VAY-zuhl-gel”, your choice—even our team can’t agree! It’s named after the vas deferens.
Is Vasalgel the same as RISUG®?
They’re related, 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.
Is Vasalgel reversible?
The idea is to develop a fully reversible long-acting male contraceptive, and recently-completed rabbit studies look promising, showing restoration of sperm flow. The baboon studies being conducted now will give even more indication.
When can I get Vasalgel?
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 in animal testing, with human trials expected to start in early 2015 (small trial) and 2015-2016 (larger trials). If everything goes well and with enough public support, we hope to get Vasalgel on the market in 2016-2017.
How expensive will Vasalgel be?
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. We’ll have to charge enough to make the company sustainable, but for sure it won’t be $800 like long-acting contraceptives (IUDs) for women in the U.S. A contraceptive shouldn’t cost more than a flat-screen TV! 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.
Will there be an age limit on using Vasalgel?
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 (a “belt and suspenders” approach) is also an option for men who want to make extra sure they can have children in the future.
How can I get into clinical trials?
A small trial on men who were planning vasectomy anyway is expected to start early next year (2015), but the larger clinical trial might not start until later that year or 2016. With thousands of men waiting to hear, it’s going to be tricky to decide who gets priority! Sign up for our email list to stay informed.
Where will clinical trials be?
We don’t yet know where the first trials will be held. Sites under consideration so far include Ohio and California. Sign up for our email list and we’ll let you know as soon as we know!
How will subjects for trials be chosen?
Initial clinical trials will likely be limited to men who are okay with potential irreversibility (i.e. don’t want any more children), since we won’t be able to promise reversibility until the reversibility study is done. For trials after that, we’re still working it out! We hope to provide priority for donors and supporters, but it depends on what regulators permit. Sign up for our email list to get updates as it takes shape.
Can I just go to India to get RISUG®?
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. We don’t know when RISUG’s developers will get it to market, although as of mid-2014 there is talk of doing a large trial/monitored release in several districts, with the hope of integrating it into the family planning program by the end of 2015. So if you live in one of those areas in India, you’re in luck! But otherwise, Vasalgel is your best bet and we hope for your support.
Are results from research on Vasalgel published?
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 2014 in open-access journals. Be sure to sign up for our email list to get summaries of study results and announcements for publication availability.
How can I help get the word out about Vasalgel?
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. Also, if you see any stories online with inaccuracies about Vasalgel, correcting those in the story’s comments section is an area where we need help!
What options do I have while waiting for Vasalgel?
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”.
Can I invest in Vasalgel? Can I make a donation?
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 riches—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)—so if you know of anybody with that kind of cash who would like to see this succeed, please spread the word!
Why doesn't Vasalgel use Kickstarter to raise funds?
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. We’ll be looking to crowdfund in late 2014/early 2015, and building awareness for the project in the meantime.
How effective is Vasalgel?
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; and the related polymer RISUG® has been effective for years in men. We don’t know yet how many years the effect will last for Vasalgel; upcoming research will help produce those answers.
Does Vasalgel prevent HIV?
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.
Why are animal studies needed?
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 new 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.
Can Vasalgel be used in dogs and cats?
Yes, 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. Want to hear updates on calcium chloride nonsurgical neuter? You can follow it on Facebook.
Tim Lewis of the London Observer covered the issue of male contraception. The comprehensive article included a history of research…
In men and women’s own words
Having control over when I have children is the foremost thing in my life. I place great value on having freedom of choice and freedom from worry. Also, being a person with not much money living in a third world country, a cheap contraceptive is imperative…
As a male I would not take any contraceptive that altered my hormonal balance. And the idea of getting a MONTHLY injection – are you crazy??? (This is probably why surveys come back saying there’s limited interest in male contraceptives – given that sort of choice, I’m not interested either!). However, a one-time injection (every 5-10 years) such as RISUG/Vasalgel that does not mess with the hormonal balance, and is reversible… what’s not to like? Sign me up, NOW please!
Terry S, Australia
I provide family planning services to young people in Southern California and would love to have more to offer the young men who come in (and their partners) much more than condoms or permanent vasectomy. I speak from the front lines that most of my clients know about condoms and are NOT using them as much as we would like.
Kristel D, Nurse Practitioner, Irvine, CA
I do not wish to further my genetic line due to a severe bleeders disease, which also makes normal vasectomy a no-go…
Condoms are a nice method; however I have a 3 year old that proves they are not 100% effective…
Frank B., father of 3, age 27, Illinois
I would like the opportunity to be more intimate with my partner and condoms bar that, beyond the conventional ‘doesn’t feel as good’ argument. However, I am extremely concerned about the failure rates of the Pill due to human error and would like to take some responsibility for my future finances into my own hands without being abstinent.
new college graduate, age 22, Florida
I want control of my fertility that is safe, convenient to use and totally effective. That way I can be in control of my life rather than putting it in the hands of women and government agencies.
S. Gee, South Korea
I am a woman and as a migraine sufferer, my contraceptive choices are limited to IUDs or progestin-only pills. Since I experience unwanted side effects with these, we rely on condoms. A longer-term “no-worry” solution would be much preferred. It would be worth the cost as opposed to an unwanted pregnancy!”
Sara D, married, no kids, Ohio
We’re newly-wed but we don’t think that we’re fit to be parents yet. I’m only 23 and I think I need to grow up a couple of years before thinking about having a baby. So, instead of wearing condoms for the coming five years or so and feeling miserable about it, I want an effective solution that I can reverse in the future because I know one day we will think of having a baby. and I do not want to put my partner at any risk by using hormonal pills. Current methods all focus on the women and all have terrible side effects (my wife cannot use IUDs) and condoms are fine until you get sick of them during intercourse and just throw them away.”