Finding an Acceptable, Long-acting, and Reversible Male Contraceptive

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Guest author Kevin S. Eisenfrats is co-founder and CEO of Contraline, Inc., a next-generation contraceptive company.

Almost every month or so, an article is published that reads “New male contraceptive is on the horizon!” MIT Tech Review has even gone so far as to say that male birth control might be one of the most interesting technologies to be released in 2021, alongside electric vehicles, virtual reality, and lab-grown chickens. Judging by the headlines, you’d think that men are as excited to try a male contraceptive as they are to drive the Tesla Model 3.

Are they excited?  We know for sure that men are NOT excited about existing methods. Condoms have a discontinuation rating of 57% and the number of vasectomies performed in the U.S. has stagnated at 500,000 per year.  We also know that men ARE interested in controlling their fertility over the long-term. In a 2005 study of 9,000 men across nine countries, 55% of the respondents reported being willing or very willing to use a new method of male contraception. That ranged from 28.5% in Indonesia to 71.4% in Spain. The most appealing frequency for taking the contraceptive? Once per year… so it seems interest among men in a long-acting contraceptive option is real.

The next question then is whether a hormonal method would be acceptable. In a recent clinical trial sponsored by the World Health Organization, men were injected with a hormonal contraceptive under development that would provide contraception for up to a year. The study regimen was not easy: each man received an injection of a testosterone and progestin derivative into his gluteus every eight weeks, and was required to come back for semen analysis and physical check-ups every two weeks. The contraceptive was found to be 96% effective (a very good rating, but not as effective as vasectomy, the Pill, IUDs, or implants).  However, a high number of adverse effects (1,491 to be exact), including acne, increased libido, depression, and mood disorders, were noted. Due to the high number and severity of these side effects, the World Health Organization stopped the study.

Despite these study conclusions, it is very important to note that more than 75% of study participants reported being willing or more than willing to use this method of contraception. Only 5% of the men who participated said they would not use the method of contraception again.

If a hormonal approach is not feasible in the near-term, could a non-hormonal, long-acting, reversible contraceptive for men become a game-changer?  At Contraline, we are developing a vas-occlusive contraceptive device that is long-lasting, non-hormonal, and reversible. The procedure involves a quick and minimally invasive procedure known as Vasintomy,TM whereby a gel is implanted into the vas deferens to block sperm flow from the epididymis into the ejaculate. Other vas-occlusive contraceptives in development include RISUG and Vasalgel.

The holy grail for a long-term male contraceptive is reversibility. Reversibility would allow the potential market to expand from just men who are family-complete to those who are sexually active. Today, vasectomy reversals take three hours, require general anesthesia, and cost up to $15,000. Not surprisingly, only 6% of men who receive a vasectomy ever get the reversal. Vas-occlusive gels are on the horizon because reversing a gel seems easier than stitching back together a ligated vas and would come with fewer side effects.

Published data on men’s acceptability of vas-occlusive contraceptives are still lacking. A recently published modeling paper assumed a conservative acceptability rate of 10% among users who would switch from existing methods as well as brand new contraceptive users. Anecdotally, Contraline routinely receives inquiries from men asking to participate in clinical trials, while the Parsemus Foundation reports to have 52,000 people on a sign-up list for its anticipated Vasalgel trials.  There is definitely potential user interest in a vas-occlusive device.

The final piece of the puzzle will be to get provider buy-in…if you make it, will physicians support its use? In my discussions with numerous urologists, I have found that most are cautiously excited about the potential for a vas-occlusive contraceptive. Many of them see first-hand the interest by their patients for a long-acting, reversible option. Demonstrating that the contraceptive is safe and highly effective, and that the procedure can be performed reliably will be key to getting urologist buy-in.

All in all, a long-acting, reversible contraceptive for men would truly be revolutionary. It would alleviate the pressure placed currently on women, the majority users of contraceptives. Even given the conservative modeling estimate of 10% acceptability, a new male contraceptive could decrease the number of unintended pregnancies around the world on the order of hundreds of thousands, potentially millions.

Who knows?  Maybe a vas-occlusive device will create as much buzz as the Tesla Model 3 among men seeking to control their fertility.  Aside from excitement, it surely would create a new realm of shared responsibility between partners, and could become a societal game-changer. Here’s to having a new, long-acting male contraceptive in the market by 2021.

 

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Categorised in: Acceptability & Product Design, Contraceptive, Male Contraception

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