The main methods of male contraception: from safe to experimental

According to WHO, about a million people become infected with sexually transmitted infections every day, and the UN Population Fund reports that the period of self-isolation, when people locked in their homes had a lot of free time, caused 1.4 million accidental conceptions. All this suggests that, despite the abundance and accessibility of various contraceptives, many people still neglect protective measures. On World Contraception Day, a holiday dedicated to education about the prevention of unwanted pregnancy and sexually transmitted diseases, we decided to draw attention to the issues of male contraception.

Most contraceptives are intended for use by women. These are hormonal pills, patches, injections, vaginal rings, coils, female condoms, a cervical cap (it is inserted into the vagina and closes the cervix, blocking sperm access to it), which can be filled with spermicides (substances that destroy sperm), etc. But Let's talk about “male” ways.

Condoms

Of the male contraceptives, we are very familiar with condoms - to this day they are the best barrier method that can highly effectively prevent both pregnancy and STD infection.

Previously, Roskachestvo examined condoms for density, permeability, and safety. In general, all the tested products turned out to be quite good, however, in some we found zinc and isopropanol, in one sample there was a small defect, in the majority there were deviations in the acid-base balance. What all this means and whether it is dangerous, as well as which “product number two” successfully passed the test, will be revealed in our study.

"Vazalgel"

Vasalgel is a serious competitor to RISUG and all other contraceptive methods. A report of its use in rabbits has just appeared in Basic and Clinical Andrology, authored by Donald Waller [11].

"Vazalgel" consists of styrene-alt-maleic acid dissolved in dimethyl sulfoxide. It is injected into the vas deferens in the same way as RISUG and, upon implantation, forms a hydrogel that tightly fills the lumen of the vas deferens (Figure 2). This semi-permeable gel barrier mechanically prevents sperm from passing through it. Small molecules and ions present in sperm in addition to spermatozoa freely cross the “obstacle” [12].

Figure 2. How does Vasalgel work?

Parsemus Foundation, picture adapted

The scientists tried two types of gel that differed in the ratio of styrene to maleic acid, and both were effective.

"Vazalgel" quickly caused azoospermia - already 29-36 days after its administration, sperm disappeared from the semen. Of the 12 rabbits, in 11 this effect persisted 12 months after the administration of the gels, and oligospermia was detected in one animal. The impact on the structure of the ducts is minimal, and after removal of the gel, nothing should interfere with the restoration of fertility. The developers are confident that Vasalgel can become the first male contraceptive of its kind, and continue to study it, focusing on the process of removing the hydrogel from the ducts. In addition, they believe that the development has advantages over RISUG: the new gel composition is easier to produce and more stable.

Hormonal contraceptives in tablets

The search for such a contraceptive has been going on for a long time, but so far there is apparently no way to make seminal fluid “safe” without significant risks to men’s health.

By the way! Female oral contraceptives in general are also not without risks. In particular, taking hormonal drugs for unwanted pregnancy may increase the risk of developing cardiovascular diseases. They are mainly affected by smoking women over 35 years of age while taking oral contraceptives. The higher the age and the number of cigarettes smoked per day (if there are more than 15, then this is already critical), the higher the likelihood of developing such conditions, reports WHO.

However, there are some developments that may appear in pharmacies in the coming decades. For example, The Journal of Clinical Endocrinology & Metabolism describes a trial of a contraceptive for men. According to the developers, the drug is administered as an injection once every two months, it contains a synthetic analogue of testosterone and progesterone - they act on the pituitary gland (the part of the brain that “gives the command” to the testes to produce sperm). Tests have shown the effectiveness of such injections, however, to make a final conclusion about the work of the drug, many more volunteers are needed. But there weren’t enough of them in the experiment anyway, and 20 people refused to continue participating due to side effects such as mood swings, depression, decreased libido, acne (remember that female contraceptives are also not without such “side effects”).

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“I avoided those women who could tie me down with the birth of a child […]. However, maybe there were children [...], but I pretended as if they weren’t there.” Lev Tolstoy. Kreutzer Sonata

The use of female contraceptives has become so widespread that even environmentalists are sounding the alarm: fish are dying from synthetic estrogens entering reservoirs along with wastewater [1]. But, despite the widespread use and availability of contraception, almost half of all pregnancies, even in the richest countries, are unplanned [2].

About 80% of men believe that women and men should bear equal responsibility for making decisions about contraception [3]. In addition, despite all the benefits of condoms, including those associated with the prevention of sexually transmitted diseases, up to 50% of men would like to use other methods of reversible contraception. If only they were [4], [5].

Folk and extreme methods

There are other hormonal contraceptives for men, but they are not fully tested and have undesirable effects.

All other methods are too poorly studied or even refer to “folk” methods, so it is too early to talk about them seriously. Such “contraceptives” include injections with a viscous substance (for example, polyurethane, which hardens after injection) that will block the seminal ducts, or thermal contraception. The latter method has been known for centuries and is based on regular overheating of the genitals (for example, a daily hot bath), because an increase in testicular temperature leads to impaired sperm production. Researchers at the University of California, Los Angeles Medical Center write that in theory, heating a man's genitals could be an effective and reversible method of contraception: when the heat is removed, function returns to normal over time. However, the method has not been studied enough and cases of male infertility have been recorded over several months and even years.

Selection recommendations and precautions

When choosing male hormonal contraceptives in tablets and alternative methods of protection against unplanned conception, it is recommended to pay attention to the following conventions:

1. The need for reversible or irreversible loss of fertility.
2. Having a permanent sexual partner.
3. The general health of the man and the presence of chronic diseases.

Hormonal tablet contraceptives for men can be recommended if the man does not have severe diseases of the cardiovascular and endocrine systems, and only if he has contact with a regular sexual partner.

Regardless of age and health status, men are strongly discouraged from using homemade methods of contraception, since any chemicals and high temperatures can lead to irreversible consequences in the reproductive system.

Interrupted and prolonged sexual intercourse is also not able to fully protect against pregnancy, and especially against STDs. If your health does not allow the use of hormonal birth control pills for men, latex condoms are recommended as an effective alternative. Products selected in accordance with anatomical features will make intimacy as bright and safe as possible.

"Women's Lobby" against it?

On the Internet you can find loud statements that it is not side effects that are preventing the creation of male contraceptives, but “scandals caused by feminists.” According to the authors of these tests, women deliberately prevent male contraceptive drugs from entering the market because they want to make the sole decision about having children and thus manage the financial and other resources of men.

As a rule, the authors of these texts are poorly familiar with the history of clinical research on male contraceptives or deliberately ignore this data. They regularly mention drugs whose trials had to be stopped, but do not talk about the dangerous side effects of these drugs. For example, the author of the above text claims that gossypol (a polyphenol found in cotton seeds) was successfully tested in China as a contraceptive in the 1970s, but a “feminist scandal” prevented its release in the West.

There really was a scandal - at an international conference on population, which took place in 1974, the creator of a drug based on gossypol and the American feminist Betty Friedan communicated in a raised voice.

But the prospects for gossypol were dashed not by this dialogue, but by the test results in China themselves. After analyzing them, the World Health Organization concluded that the substance cannot be used as a contraceptive.

More than ten thousand volunteers participated in the trials, and gossypol was really good at preventing conception. But scientists have recorded many side effects of the drug: weakness, dizziness, stomach upset, decreased libido, problems with potency. In addition, fertility in many participants in the experiments was restored very slowly. 10% of 8,806 volunteers in one trial experienced oligozoospermia, a low concentration of sperm in the ejaculate that lasted from six months to several years. In another study involving 2067 men, long-term oligozoospermia was noted in 27% of volunteers. Animal testing has shown that high doses of the drug are toxic: several laboratory monkeys died during testing. In 1998, WHO experts called for an end to trials of gossypol as a contraceptive.

Literature

1. Blanchfield PJ, Kidd KA, Docker MF, Palace VP, Park BJ, Postma LD (2015). Recovery of a wild fish population from whole-lake additions of a synthetic estrogen. Environ. Sci. Technol. 49, 3136–3144;
2. Kanakis G. and Goulis D. (2015). Male contraception: a clinically-oriented review. Hormones. 14, 598-614;
3. Plana O. (2015). Male contraception: research, new methods, and implications for marginalized populations. Am. J. Men's Health. pii: 1557988315596361;
4. Kogan P. and Wald M. (2014). Male contraception: history and development. Urol. Clin. North. Am. 41, 145–161;
5. Heinemann K., Saad F., Wiesemes M., White S., Heinemann L. (2005). Attitudes toward male fertility control: results of a multinational survey on four continents. Hum. Reprod. 20, 549–556;
6. O'rene D. A. (2013). The origin of the word "condom". Today I Found Out;
7. Kruck WE Looking for Dr. Condom. University of Alabama Press, 1981. - 112 p.;
8. Zdrojewicz Z., Konieczny R., Papier P., Szten F. (2015). Brdt bromodomains inhibitors and other modern means of male contraception. Adv. Clin. Exp. Med. 24, 705–714;
9. Chao J. H. and Page S. T. (2016). The current state of male hormonal contraception. Pharmacol. Ther. 163, 109–117;
10. Roth M. Y. and Amory J. K. (2016). Beyond the condom: frontiers in male contraception. Semin. Reprod. Med. 34, 183–190;
11. Waller D., Bolick D., Lissner E., Premanandan C., Gamerman G. (2016). Azoospermia in rabbits following an intravasal injection of Vasalgel™. Basic Clin. Androl. 26, 6;
12. Owen D. H. and Katz D. F. (2005). A review of the physical and chemical properties of human semen and the formulation of a semen simulant. J. Androl. 26, 459–469;
13. Spermatogenesis: through thorns to the stars;
14. Finally: a birth control pill for men!;
15. Roth M.Y., Page ST., Bremner W.J. (2016). Male hormonal contraception: looking back and moving forward. Andrology. 4, 4–12.

Who's ready?

Creating a reliable and safe contraceptive drug for men is not everything: it is fundamentally important that people agree to use it. Despite doubts, sociological survey data show that many men would like to try such methods of contraception.

Cambridge sociologist Susan Walker conducted a survey of 188 Britons (134 women and 54 men) who were already using other methods of birth control. 49.5% of respondents said they would be willing to try male birth control pills. At the same time, 42% of survey participants were afraid that men might forget to take the drug on time - as expected, women expressed this suspicion much more often than men. Only 26% of respondents were concerned about the possible negative impact of male contraceptives on health.

In 2005, scientists led by Klaas Heinemann surveyed more than nine thousand men from the United States, Indonesia and several countries in Europe and Latin America. On average, 55% of men were not against trying a new method of contraception. In Indonesia, only 28% of respondents decided to do this, in Spain - 71%.

Most men named daily pills as the most convenient method of contraception, but residents of Europe, Asia and the Americas put different options in second place on the list.

Europeans preferred implants that need to be replaced once a year, and in Latin America, the second most popular form of implants was a gel form that needs to be rubbed into the skin. People with a higher level of education were more likely to agree to try male contraception, but the religion that the respondents adhered to had virtually no effect on their position towards contraception.

Clean sheets, sluggish sperm

Polymer gels are not the only way of non-hormonal contraception for men. For example, in April 2021, an organic compound that can slow down sperm movement was successfully tested in the United States. Like Vasalgel, the “inhibitory” drug was tested on laboratory rhesus monkeys - their anatomy is in many ways similar to that of humans.

The contraceptive compound, known as EP055, blocks the activity of the protein EPPIN (epididymal protease inhibitor), located on the surface of sperm. EPPIN binds the protein semenogelin, giving sperm the desired degree of viscosity. The consistency of the liquid affects how freely and quickly sperm move, and therefore the likelihood of conception: inhibited cell movement is one of the common causes of male infertility.

To “break” EPPIN and slow down sperm, the creators of the new drug used triazine derivatives. These substances are widely used in chemistry: they include components of many synthetic paints. A few hours after intravenous administration of EP055, sperm motility in macaques dropped to a level that reliably protected against conception, and began to recover only after three days; no side effects were found in the monkeys. Researchers are now working on a tablet formula based on EP055.

Another experimental method of non-hormonal contraception uses the anatomy of sexual intercourse. It is known that male orgasm does not always end with ejaculation. Typically, dry orgasm is considered a physiological disorder or an unpleasant side effect of certain drugs, such as phenoxybenzamine, which dilates blood vessels, but the creators of contraceptives were able to benefit from this phenomenon. The “Clean Sheets Pill” technique reproduces this condition artificially: such drugs do not allow the longitudinal muscles that push sperm through the vas deferens to contract. At the same time, the muscles associated with achieving orgasm still work - the pleasure from sex will not go away. According to the creators of the method, their drug was successfully tested on animals, but now development has been suspended (the reason is still the same: lack of funding).

There are also many experimental technologies: including targeted destruction of genes associated with the structure of the sperm, and effects on proteins specific to the testicles, and blocking spermatogenesis using derivatives of the antitumor agent lonidamine. All these methods are constantly being refined, acting more and more subtly.

Contraception for men: why are there no male birth control pills?

The vast majority of effective and popular methods of contraception, with the possible exception of condoms, are based on the principles of the female body and its physiology. However, there are also purely male methods of contraception. There are really few of them, many of them are just in development, but let’s figure out when we can expect male contraceptive pills and whether we can expect them at all. At the moment, the most effective method is surgery. The operation, called a vasectomy, is performed in such a way that sperm do not penetrate into the ejaculate. The effectiveness of vasectomy is considered to be quite good: although pregnancy still occurs, the frequency is quite low, and it completely decreases after 72 weeks after the operation. Currently in Russia, vasectomy is prohibited for men who do not have two children or are under the age of 35. In this regard, as well as the risks of developing various complications due to surgery, there is an urgent need to develop pharmaceutical methods of contraception. A gel that blocks sperm production and birth control pills are currently at the stage of clinical trials, but all these products will not come to our pharmacies any time soon. Let's try to understand why it is so difficult to develop male contraceptives?

A large clinical trial of injectable hormonal contraceptives was stopped in 2021 due to concerns about the development of serious side effects. The articles also wrote that men are not able to cope with daily medication intake like women. Unfortunately, this is true: as a rule, adherence to therapy is lower in men than in women. Side effects included acne, increased libido, injection site pain, muscle pain, depression and other mental disorders: About 17% of participants experienced so-called emotional disorders during the study period, but these were not severe. Men were blamed in the press for women coping with these side effects: for example, many women experience depression and other mental disorders, some hormonal drugs can cause acne, and some can even be painful. Interestingly, despite all the side effects found, 75% of sites wanted to continue using this method of contraception after the end of the study. Finding new methods that are approved for use and that pay off sufficiently is incredibly difficult. The first challenge for researchers is to overcome the natural process of spermatogenesis. Men produce hundreds of millions of sperm every 24 hours. The problem is that only one of them is needed to fertilize a female reproductive cell. Even if we reduce the number of sperm produced by 99%, men will still remain quite fertile. The female body, on the contrary, usually produces one cell ready for fertilization per month. Controlling the female body is easier, if only because it is a matter of mathematics. So, the first reason is the difficulty of overcoming the physiological structure of the male body. In addition, historically, the need for the development of female contraceptives was much greater. Pregnancy and childbirth are very serious stress for the female body, in some cases they can even cause disability and death. Men do not have such a problem, so the attention of scientists did not reach them for a long time. Female contraceptives have gone through many, long stages of testing. Male contraceptives should be at least as safe and effective as female ones. Considering modern developments, it is difficult to say that at least one of these goals has been achieved: the effectiveness of most methods is much lower (and this is directly related to the biological reasons mentioned above), and safety is not comparable. For all these reasons together, pharmaceutical companies turned a blind eye to the issues of male contraceptives for a long time and did not particularly try to start developments in this area. But to date, some progress has been achieved. The main dosage forms currently in development are tablets and injections, but gels are also being developed. One of these gels is Nestoron. It contains testosterone, the male sex hormone, and progestin, a synthetic form of the female sex hormone progesterone. In the male body, progesterone is also produced (like testosterone in the female), but in disproportionately smaller quantities. This gel had to be used daily, rubbing into the hands. The progestin in the gel blocks gonadotropin, which is responsible for the production of testosterone. Sperm production requires high testosterone production in the testes, so targeting this link by reducing testosterone concentrations in the testes can be effective.

However, there is a certain problem: the level of testosterone in the blood will also decrease. Because of this, side effects from the reproductive system will be observed, such as decreased libido and problems with potency and ejaculation. Because of this, the gel also includes testosterone, which enters the blood, but does not enter the testes. In a 2012 study, the gel showed good results: about 90% of participants had a sperm count of 1 million per milliliter or less. It is already possible to work with such a quantity of sperm: the female body does not allow all the sperm to pass through, since they are destroyed as they move through the genital tract. Another large multi-center study of the gel in several countries is currently recruiting: it is planned that 420 couples will use the gel exclusively over 12 months. Despite the fact that development has already advanced quite far, the drug is still far from entering the market. Another way is birth control pills. There is an additional problem with them: the drug is eliminated from the body so quickly that more than one tablet is required per day. But now scientists have come close to solving this problem. The substance dimethandrolone undecanoate (DMAU) was found to be safe. The effect of the drug is observed for at least 18 hours, which means it can be taken once a day. The drug works similarly to Nestoro gel. DMAU is a steroid molecule that has the properties of testosterone and progestin. Hormonal changes that occur in the body suggest a decrease in sperm production, but scientists do not yet know for sure whether this actually occurs. The thing is that the research was rather short-lived. Volunteers are now being recruited to participate in a new study, which will take 12 weeks, then it will be possible to say something concrete. There are studies of an injectable form of this substance. It is expected that the injection will be required every few months. There is another interesting option - non-surgical vasectomy. In general, a vasectomy is an operation to ligate or cut the vas deferens, which is why sperm do not ultimately penetrate the urethra. Scientists are researching a method called reversible sperm under surveillance, or RISUG. The method involves injecting a gel into the vas deferens to block the movement of sperm, rather than cutting or tying it. This method is reversible. Judging by the research results, the effectiveness in preventing pregnancy is quite comparable to female contraceptive methods, and also does not have serious side effects. This method is gradually spreading in India, but the drug is just trying to go abroad.

How to choose a method of male contraception

For men in regular relationships, the method of interrupted coitus may be suitable, but it should be taken into account that there is a risk of pregnancy. If the couple does not plan to have more children, then a vasectomy can be done. For others, a condom is the safest option.

Innovative methods such as pills, vas deferens plugs, and oral male contraceptives are not yet on the market. Hormonal drugs as a method of contraception are questionable because they provoke serious side effects.

We talk about the signs of a girl's sympathy - we promise, you will learn something interesting.

Market question

The male contraceptive industry has been growing slowly over the past decade as large pharmaceutical and biotech companies have largely withdrawn from the industry. Funding from governments and private individuals was also extremely low. As a result of limited funding from government and philanthropic supporters, most clinical trials of the effectiveness of male contraceptives have been relatively small [15].

Despite the uncompetitive entry into the market, Vazalgel, according to the manufacturer, will be an affordable product - its cost should not exceed the level of daily earnings in developed countries.

The original version of this article was published in the journal Urology Today.

Use of the drug "Vasalgel"

We turned to the developers of the innovative contraceptive about the use of Vasalgel in clinical practice.

“The first clinical trial will begin enrollment in the first quarter of 2021 in the United States, but the exact date, location, and protocol have not yet been established,” responded Ben Carlson, director of press for the Parsemus Foundation. — Presumably, the protocol will involve about 30 patients who are candidates for vasectomy. This choice regarding the profile of participants is due to the fact that we have not yet proven the reversibility of the contraceptive effect of Vasalgel.”

According to the official statement of the Parsemus Foundation, the development and research of Vasalgel is a social project and is not aimed at enriching pharmaceutical companies.

A larger clinical trial will be conducted at the end of 2021 or in 2021, after which it is planned to introduce Vasalgel to the market.

Who needs such drugs and why?

Today, we have many types and forms of contraceptives available to women: single-hormone or multi-hormone pills, injections, hormonal rings, intrauterine devices, subdermal implants, diaphragms and uterine caps. With such variety, why look for products suitable for men?

First, surveys show that many men in heterosexual relationships would like to share responsibility for contraception with their partner and are willing to take birth control pills. In addition, modern feminine products have many unpleasant side effects, so making a choice is difficult even among the existing variety.

OB/GYN Regan McDonald-Mosley, chief medical officer for Planned Parenthood, says:

“It’s important to note that contraceptive methods are not universal: what works best for one person may not work for another.”

According to the doctor, when choosing contraceptives, people take into account many factors: the effect of the method on the body, the risk of side effects (and willingness to put up with them), ease of use, partner consent and the cost of contraceptives. MacDonald-Mosley believes the new methods will give men and women more options to find the most convenient method of contraception.

She emphasizes: the ability to choose the right contraceptive from a variety of options directly affects not only the lifestyle of men themselves. Women, future children, and society as a whole will benefit from this. Planning a pregnancy means more stable families, more opportunities to freely distribute finances and provide children, for example, with a good education.

Perhaps the emergence of new methods of contraception will help reduce the number of accidental and unwanted pregnancies. Despite the abundance of contraceptives, this problem is still relevant throughout the world. For example, 49% of pregnancies in the United States are unplanned (this number includes both unwanted and untimely ones). In Russia, according to 2011 data, up to 23% of pregnancies were unwanted, and up to 44% were untimely. Reducing the number of such pregnancies will also help reduce the number of abortions, including illegal ones in countries where the procedure is prohibited.

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Reviews from doctors

To the question that concerns many people about the likelihood of getting pregnant from lubricant, doctors answer that this is impossible. Example from the site https://sprosivracha.com/questions/278917-prervannyy-polovoy-akt: