Each year, researchers report: male contraceptives are about to hit the market. But this does not happen in any way. We will tell you why they are so difficult to invent, who and how tried to do it, and why the idea of male contraceptives in general is rather controversial.
For convenience, this text uses well-established formulations "female contraceptives" and "male contraceptives". However, “male” or “female” contraceptives may be needed by people of any gender identity.
In early 2019, announcements appeared in many foreign media outlets: scientists are conducting research on a contraceptive drug for men and are looking for volunteers. Heterosexual couples who regularly have sex were invited to participate in the two-year experiment. Male volunteers were asked to apply contraceptive gel to their arms and shoulders every day and to appear at the clinic once a month for examination.
This is the NES / T contraceptive gel, one of the most promising new developments in the field of male contraception. It contains the hormones testosterone and a progestin derivative called nestorone. The latter reduces the number of sperm in the ejaculate, the former supports sexual function. A small amount of NES / T just needs to be applied to the skin, it is absorbed in half a minute. This is not the first study - the safety of the gel in healthy men has already been studied previously.
Michael Medrano, a Los Angeles volunteer, says the new drug has made him "a little sulky," but overall he is achieving the desired result so far: Michael's wife Julia is not pregnant. In addition, she was able to give up her contraceptive drug, which caused her weight to fluctuate and her mood was unstable.
When Michael tells his friends that he is testing contraceptive for men, they are surprised: most of them have never heard of such a thing. But, according to him, having grasped the essence, friends ask when they will also be able to use the new miracle gel.
In addition to Michael and Julia, about 400 couples from different countries are participating in the tests. It is believed that if the experience is successful, NES / T could become the first male contraceptive drug on the market. However, even this will not happen very soon, the current study is scheduled to be completed at the end of 2021.
It seems that male contraceptive is an innovation, but in fact, development in this area began more than sixty years ago, almost simultaneously with the development of drugs for women. But in the course of experiments, it turned out that the situation with male contraceptives is much more complicated.
Control to women
The first to start working on hormonal contraceptives - for both men and women - was the American endocrinologist Gregory Goodwin Pincus. He investigated how hormone levels are associated with various body conditions and diseases. Pinkus was friends with Margaret Sanger, an activist and founder of the Planned Parenthood International Association. Sanger fought for women's rights. She was unhappy with the fact that men often do not allow women to control the issues of childbirth themselves: men could insist on sex without a condom or secretly remove the contraceptive at the last moment. Women, on the other hand, due to an unplanned pregnancy, had to either have abortions, or go against their own plans, interrupt their careers or even risk their health in order to give birth to a child.
It is believed that it was Sanger who inspired Pinkus to begin research on how hormonal levels affect the menstrual cycle and ovulation.
Pincus developed the first hormonal contraceptive drug for women - Enovid. At first it was formally called "a drug for the treatment of menstrual irregularities."It was the first generation oral contraceptive - it contained high doses of hormones and had many side effects. For example, he could provoke a thrombosis. Nevertheless, he was wildly popular: many women were ready to take risks in order to gain control over their own bodies. In 1960, the FDA officially authorized the drug to be marketed as a contraceptive rather than under the guise of "treating menstrual irregularities."
While doing research, Pincus noticed that the synthetic hormone progestin can affect not only the menstrual cycle, but also hormone production. He decided to start developing a similar drug for men. But if for his previous invention he received a grant from the International Family Planning Association, this time the organization did not want to sponsor him. Margaret Sanger, who helped with the financial side of the matter, was furious. Her idea was to give women control over their fertility. Now, in her opinion, Pincus wanted to regain control of the men again.
The scientist still managed to carry out some experiments. He administered injections to patients in psychiatric hospitals (at that time, medical ethics were poorly developed). But the results were inconclusive. Pincus interrupted research.
In the 70s, scientists, together with medical organizations, resumed work on male contraceptives. The governments of different countries at that moment were puzzled by the problem of overpopulation, so the question was acute. Experiments were carried out all over the world - not only hormonal drugs were investigated, but also any others.
Once the Brazilian scientist Elsimar Coutinho saw how local farmers feed the bulls with unnecessary plant leftovers from cotton plantations. Farmers believed that the plants had a beneficial effect on the sexual power of bulls. Indeed, the cotton-eating animals were sexually active. But the birth rate among cows was low.
So he realized that gossypol - a natural compound obtained from cotton - could potentially become a means of male oral contraception. Since the 1960s, Coutinho has been working on his development with the support of the Chinese government: the country has become interested in a drug that will help with the problem of overpopulation. In 1972, a scientist conducted a study, eight thousand men tried gossypol tablets on themselves. The subjects' sperm count dropped, but side effects were found. 66 volunteers had low blood potassium levels. In addition, after the end of the study, the level of sperm in some men did not return to their previous level.
Nevertheless, in 1974, Coutinho went to the International Conference on Population and Development and spoke about his promising experiences. “There was a full hall of women,” he recalls. "They booed me." It turned out that the attendees of the conference did not at all think that men should be entrusted with control over contraception.
Ten years later, the Chinese sponsors of the study said that further study of gossypol was of little interest to them. Nevertheless, together with a team of scientists from different countries, Coutinho continued his research, and they turned out to be more successful. In 2000, they proved that the drug did not affect potassium levels, and poor nutrition in a Chinese sample affected its performance.
The scientist turned to the Brazilian government: he wanted gossypol to enter the market. But due to the strong influence of the Catholic Church, it is very difficult to bring new contraceptives to the market in Brazil. The Ministry of Health did not dare to go against the church. However, Coutinho himself thinks that the problem lies elsewhere: "Over the many years of work, we realized that men are very afraid of losing fertility."
Another promising method of contraception appeared in India in the 1970s. At first it was called RISUG - "Reversible Directed Sperm Inhibition".It was invented by Dr. Suja Gua, professor of biomedical engineering at the Indian Institute of Technology. The essence of the method is that a person is injected by injecting a polymer gel into the vas deferens. The gel works like a filter - it allows ejaculate to pass through itself, but deactivates the sperm. The injection is done in fifteen minutes and is cheaper than a disposable syringe. One injection lasts ten years. This method resembles a vasectomy, but if desired, a person can inject an antidote (by the way, this is just soda), and the gel will cease to work. Unlike a vasectomy, RISUG is very easy to "undo".
For thirty years this method was tested first on animals, then on humans. It has proven to be very effective, and no serious complications or side effects have been documented. True, this does not mean that they do not exist. For unknown reasons, the results of the Phase III RISUG clinical trials have not been published, although they have been conducted. It is also known that in 2002 the third phase study was completed ahead of schedule. The Indian Ministry of Health explained that this was due to some side effect. No further details have been reported.
In 2010, the American company Parsemus Foundation bought a patent for RISUG for one hundred thousand dollars. Now she continues to work on the invention - scientists from the United States made small changes to the composition and named the new product Vasalgel. It has been successfully tested on monkeys and rabbits. But the Parsemus Foundation is a non-profit company - it's a small foundation that strives to provide affordable medical care to people and animals. The organization doesn't have enough funds to fund the massive Vasalgel trials, and the big pharmaceutical companies don't seem to be very keen on innovation. It turns out that Vasalgel is one of the most promising innovations that cannot enter the market, because none of the business giants sees potential in male contraception.
In addition to gels and herbal remedies, scientists are also working on conventional hormonal pills for men - analogs of female COCs. It has already become quite clear that such a tool can enter the market and it will be effective. True, things don't always go smoothly during clinical trials.
For example, in 2016, a team of international scientists from leading universities conducted a large-scale study of the most modern hormonal contraceptive for men in the form of an injection at that time. The experiment involved 320 heterosexual couples, where the age of men ranged from 18 to 45 years. For over a year, they received regular injections of progesterone and synthetic testosterone. One reduced sperm production to the point where conception is impossible, the other supported sexual function.
The result, on the one hand, could be called successful: it turned out that the new contraceptive was effective in 96% of cases (for comparison, the effectiveness of a condom is no more than 80%).
But something in the course of the experiment alarmed the scientists - so that they interrupted the tests ahead of time. Many subjects complained of side effects such as bad mood, skin rashes, muscle pain and confusion.
On the one hand, pills for women also have such effects. They were released to the market despite the fact that customers are at risk of acne, bad mood or weight fluctuations. But many women are nonetheless willing to accept these risks in order not to face unwanted pregnancies. Why don't men go for it too?
But, as the study authors explained, the percentage of volunteers who experienced side effects was too high to continue. Scientists received more than a thousand complaints from just 320 men and considered this figure colossal - although three or four ailments a year does not seem like something terrible.However, the researchers concluded that 900 of these events were drug-related. A quarter of the participants complained of pain at the injection site, half developed facial rashes, and more than 20% reported mood swings. One study participant committed suicide - however, the study authors concluded that this was not related to the effect of the injections.
Nevertheless, for the researchers, the experiment turned out to be very effective: despite the side effects, the drug proved to be effective. It remains to improve it so that it has less impact on well-being. Several hormonal treatments are under study to date, including an NES / T gel that needs to be rubbed onto the shoulders.
Professor Stephanie Page of the University of Washington School of Medicine is one of the leading scientists in the field of male contraception. She oversees three studies at the same time: one group of scientists is working on a pill that suppresses sperm production. The other is over an injectable drug - the one that caused many side effects in 2016. Now it is being finalized. The third development is the NES / T gel, which is undergoing clinical trials with might and main. According to her, none of the developments will enter the market in the near future.
According to statistics, 75% of volunteers who have experienced a contraceptive injection on themselves, would like to continue to use male hormonal contraception, despite the risk of side effects. The development could well become popular. But, according to Dr. Page, pharmaceutical companies are not yet showing interest in the topic and are in no rush to sponsor new research. Without them, things go slowly. Perhaps it's all about the stereotype that protection is primarily a woman's concern.
Whether the world needs male hormonal contraceptives is still controversial. On the one hand, as in the 70s, few women would like to entrust men with the control of fertility. According to a 2011 study, about half of women would not want such a responsibility to lie with a man, and this is not surprising, because in the event of a mistake, it is the woman who will have to deal with the consequences.
On the other hand, according to the American Medical Association's Journal of Medical Ethics, contraceptive concerns place an unfairly high burden on women. Female contraception is noticeably more expensive than male contraception - if only because the pills have to be taken every day, and men use condoms only during sex. If we talk about a vasectomy, then the cost of it is completely minimal.
If we discuss the methods of contraception that are on the market today, then women who use them are much more at risk of side effects than men. In addition, there are invisible differences: female methods of contraception require much more investment in terms of time and effort. For example, to be prescribed pills, you need to go to the doctor at least once. Plus a moral resource - stress, anxiety that contraception may not work, or because of fear of choosing the wrong method.
PHOTOS: stock.adobe.com - Maria Mudrykh