A Reversible Alternative to Vasectomies on the Horizon for 2024

November 09, 2022 - Although there are numerous forms of effective hormonal and nonhormonal birth control on the market, only two were designed for male use — condoms and vasectomies. Because of this, the burden of pregnancy prevention falls on those with a uterus. However, males looking to relieve this burden by controlling their reproductive health, especially after the reversal of Roe v. Wade, may soon have a fully reversible option to consider.

“I’m all for women being able to control their fertility, but at the same time, we can’t stop there. We need to enable men to participate in family planning because they’re part of the family,” L.R. Fox, CEO of NEXT Life Sciences, told LifeSciencesIntelligence. “With the reversal of Roe through Dobbs, we’ve seen 3 times increase in men seeking out vasectomies.”

Urologists in numerous states across the United States have reported a sharp increase in the number of patients seeking vasectomy consultations and a massive uptick in internet traffic on their vasectomy information website pages.

In Ohio — a state facing strict abortion bans since the overturning of Roe v. Wade — the Cincinnati-based Urology Group reported that vasectomies have increased in June, July, and August compared to the same months in 2021. If the physicians at The Urology Group performed all the vasectomies they had scheduled for August 2022, that month alone would have seen an 80% increase compared to the same month the previous year, the practice noted.

“Women are the ones that carry and give birth to the babies, so they carry the added burden of prevention. But what if we didn’t shift the burden and we, as men, could alleviate that burden?” questioned Fox.

What Is Vasalgel?

Vasalgel — developed by the Parsemus Foundation, Revolution Contraceptive, and NEXT Life Sciences — is a long-acting, nonhormonal, and reversible contraceptive hydrogel for men. The proprietary hydrogel is a biocompatible polymer injected into the vas deferens, blocking sperm but allowing ejaculation.

“Through studies done in India, it lasts for well over 10 years,” revealed Fox. At that point, patients will have the polymer dissolved and have the option of repeating the Vasalgel procedure for more extended fertility control. 

“The goal is to create a safe, simple, and effective method: a quick, 10-minute, pain-free procedure that gives ten years of thought-free protection that is reversible on demand — 10 days, 10 months, or 10 years later.”

FDA Approval Timeline

Vasalgel is only in pre-clinical studies right now. Still, Fox remains optimistic that clinical trials of Vasalgel will start at the end of 2023 and be available to the market the following year.

Because the FDA has yet to approve similar contraceptives, Fox admitted that the organization is working tirelessly to get through the regulatory system as well as work with Congress to introduce legislation that will help to support and encourage the regulatory process to develop processes for male birth control.

Cost and Outreach

The annual cost of female birth control options in the United States can vary from $0 to over $2,000, depending on insurance coverage. According to GoodRx, the average annual out-of-pocket cost of birth control is $226 for people with insurance and $268 for those without insurance.

At this time, the cost of Vasalgel has not yet been announced, but Fox emphasized his organization’s commitment “to ensuring that Vasalgel can reach everyone who needs it. It doesn’t matter how much or little money or resources they have or where they are in the world. No matter how urban or rural — they need equal access.”

Although vasectomies aren’t covered under the Affordable Care Act, many insurance plans cover all or part of the costs related to the procedure and follow-up visits. The average vasectomy costs $1,000 — although it is more expensive up front, this method of contraception is still six times cheaper than female sterilization.

“Will men pay some basic sum of money to choose the destiny and future of their life? I think so,” he insisted.

Safety and Efficacy

According to Fox, proper implementation has proved Vasalgel to be 100% effective across all his organization’s studies.

“From a side effect perspective, the side effect profile is so low that we’ve yet to see any major notable side effects with Vasalgel. In fact, vasectomies have a relatively low side effect profile themselves, but this is a better, faster procedure with fewer side effects and less discomfort than a vasectomy,” he noted.

Although a vasectomy is the most effective form of male sterilization in the US, Fox explained that “post-vasectomy pain syndrome, reported in a very small percentage of men (1–2%), causes some discomfort due to swelling or pressure.” These people, unfortunately, experience chronic testicular pain for longer than three months after the procedure.

Issues Associated with Traditional Methods of Pregnancy Prevention

Considering the bar set for traditional and modern female contraception options — with side effects including nausea, weight gain, depression, blood clots, and suicide — prospects are good for Vasalgel. “When the first female oral contraceptive was made, it wasn’t effective and definitely wasn’t safe,” Fox pointed out.

In the US, the first hormonal contraceptive for women, known as “the pill,” was made available in 1960. Although nearly 100% effective, the pill came with severe side effects such as life-threatening blood clots because the FDA-approved dosing was ten times too high, as was later determined.

“And with the IUD, most people don’t realize that reusable menstrual cups can dislodge an IUD because of the suction created when pulled out,” Fox cautioned by referencing an Obstetrics & Gynecology study that found women who use a menstrual cup had a higher rate of copper IUD dislodgment than those who used tampons or pads.

The Future of Male Contraception

In an in-depth survey comprising 9,000+ men aged 18–50 years from nine countries, 28.5–71.4% of various nationalities expressed willingness to use a male hormonal contraceptive, with an overall willingness rate of 55%. In another study of the attitudes of Australian men toward male contraception, 75.4% of the new fathers interviewed indicated a willingness to try a male method, including oral contraception and injections, if available.

“While the concept of a male oral contraceptive is great, and there should be a marketplace of options, will women trust men to take a birth control pill every day? As a man, I don’t even trust men to take a pill every day.” Fox reiterates that the goal of Vasalgel is to create a male birth control option that users can “set it and forget it,” much like an IUD but without the increased burden.

As more male birth control options advance into clinical trials, Fox told LifeSciencesIntelligence that he is “excited to see younger generations and their desire to participate and be more involved in the planning process, alleviating the burden — not shifting the burden.”