Analysis Sexuality

Male Birth Control Pill Is Still ‘Right Around the Corner,’ Like It Has Been for Years

Martha Kempner

We regularly learn about how research is progressing toward creating alternative forms of reversible contraception for men that include pills, shots, or other devices. Despite the flurry of excitement these news pieces generate, it seems we are still quite far from mass-marketed male birth control.

Seemingly every year, we learn about how research is progressing toward creating alternative forms of reversible contraception for men that include pills, shots, or other devices. Despite the flurry of excitement these news pieces generate, it seems we are still quite far from mass-marketed male birth control. This month’s advance—a trial that successfully rendered mice temporarily infertile—is cut from the same cloth: It is a valid proof of concept, but likely quite a few years away from being realistically accessible on pharmacy shelves.

The new study, published in the journal Science, showed that researchers in Japan were able to block a specific protein necessary in the production of sperm—and more importantly for human men seeking a non-permanent contraception, it showed that normal sperm production resumed soon after the mice were taken off the drugs.

Specifically, scientists were examining a protein called calcineurin, which they have long suspected was instrumental in male fertility. To test this part of their theory, they genetically engineered mice that could not fully produce calcineurin and found, as suspected, these mice were infertile because the sperm they produced were not flexible enough to fertilize eggs.

Once they had tested that hypothesis, they moved on to trying to block the calcineurin in normal mice. They did this using two existing drugs—the antibiotic cyclosporine and tacrolimus, an anti-rejection drug given to patients who have had organ transplants. (Interestingly, infertility in humans is not listed as a side effect for either medication.) Within four to five days of receiving the drugs, the mice became unable to impregnate their female companions. And, within a week of being taken off the drugs, fertility returned.

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As reported by HealthDay, researcher Masahito Ikawa of Osaka University said, “It is important that we find an effective and reversible contraceptive option to allow men more control over their own reproductive futures. … The findings of this study may be a key step to giving men that control.”

Others agree that these results are exciting. Patricia Morris, director of biomedical research at the Population Council, said that this was an interesting approach because it did not involve hormones. She told Live Science, “Approaches to male contraception that target hormones can affect sex drive and thus are less desirable as contraceptives.” She added that this approach was exciting because it was so specific—targeting just one protein—and therefore, less likely to have side effects elsewhere in the body.

But in some ways this study is just a proof of concept. The researchers aren’t suggesting that the two drugs they used in mice be used in men for contraception, because both suppress the immune system, leaving a person more at risk for illness and infection. Both drugs also increase the risk of lymphoma and skin cancer. So before these findings can be translated into a monthly birth control pack for guys, researchers must first see if the effects of blocking calcineurin are the same in humans—findings in mice are often replicated in humans, but not always. Then they have to find a less toxic way to block the protein.

As Rewire has reported, there are many other attempts under way to create and perfect male birth control. For example, last year, scientists were able to render three baboons infertile by using something called Vasalgel, which is injected into the vas deferens and blocks sperm from coming out during ejaculation. This is same principle used for a vasectomy, but that procedure is permanent and severs the vas deferens. Vasalgel, which is currently undergoing testing, is intended to be reversible. It can be flushed out of the vas deferens with a second injection if a man decides he wants to be fertile again. A similar product called RISUG (reversible inhibition of sperm under guidance) is being developed in India.

As scientists continue their quest to find a new male birth control method, it remains unclear how excited most men are for these products. A survey reported in U.S. News and World Report found that 66 percent of men might be interested in a pill, 44 percent might try a shot, and 36 percent were interested in an implant.

Of course, such surveys are based mostly on hypotheticals for now. The men surveyed, for example, might not have known that some of the shots in development are intended to be administered directly into the testicles, which may have affected their reactions. And regardless, it will be many more years of studies on primates, mice, and men before anyone we know will really have to decide whether that’s something he’s willing to undergo in order to take control of his own fertility.

Roundups Sexual Health

This Week in Sex: A Reason to Celebrate on Tax Day?

Martha Kempner

Same-sex married couples get a long-awaited policy change (but maybe not a tax break), there’s encouraging news about the development of a male contraceptive method, and the month of April brings some much-needed attention to sexually transmitted diseases.

This Week in Sex is a summary of news and research related to sexual behavior, sexuality education, contraception, STIs, and more.

Tax Day 2016: A Reason to Celebrate for Same-Sex Couples

Many in the United States dread this time of year because it means dealing with the Internal Revenue Service (IRS). But there is something to celebrate this time around: 2016 is the first year that every married same-sex couple can file both federal and state taxes together.

After the U.S. Supreme Court ruling striking down part of the Defense of Marriage Act in 2013, the IRS changed its rules to allow legally married same-sex couples to be treated as married for federal tax purposes. While this was a step forward for equality, it actually made tax filing far more complicated for some couples, as NPR explains. Those who lived in a state where same-sex marriage was not recognized would have to file federal taxes as a married couple, but state taxes as individuals. To make matters trickier, state taxes are often based on your federal tax return; some couples had to create mock individual federal returns just to figure out what they owed their state.

This all changed in June 2015, when the Supreme Court ruled in Obergefell v. Hodges that no state can prevent same-sex couples from marrying and all must recognize their unions, effectively legalizing marriage equality nationwide. So this makes Tax Day 2016 the first day that all married couples—regardless of gender—will be treated equally.

While many are celebrating the symbolic victory, some couples may be shocked to find out that they actually owe more taxes as a married couple.

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Another Step Toward Male Contraception

Over the last few decades, researchers have developed numerous ways to prevent pregnancy, from hormonal pills that block ovulation to IUDs that slow the movement of sperm through the reproductive tract. Up until now, male contraception has been limited to one barrier method, condoms, and one permanent one, vasectomies. Now, a new study lends some proof of concept for possible reversible male contraception methods.

As Rewire has reported, one method in development, known as Vasalgel, is intended to be injected into the vas deferens and create a physical barrier preventing sperm from leaving the testicles. Scientists behind Vasalgel say they intend for it to be reversible with another injection. This could be on the market as soon as 2018. But scientists are still looking for other ways to temporarily render males infertile—possibly ones that do not involve an injection into the testicles.

A new study suggests new chances for one such method. University of Virginia researchers are focused on an enzyme known as TSSK2, which helps make sperm motile. They think this enzyme could be the key to a contraceptive method because it is only found in the testicles and only involved in the very last state of sperm production. In theory, this means that blocking this enzyme could produce nonswimming sperm without causing side effects in the rest of the body. They have found a way to mass produce this enzyme in a laboratory, and their next step is to test existing drugs to see if any can bond only to TSSK2 in the testicles without affecting the rest of the body.

Clearly, they are years away from an actual male birth control pill based on this concept. But this is not the only idea for a male birth control pill under development. As Rewire reported last year, other scientists are working with existing drugs to block a protein called calcineurin and have successfully rendered mice infertile by doing so.

While men wait—though it’s still unclear if many are really interested in their own pill—we should all remember that between condoms, pills, patches, rings, and IUDs, there are many methods couple can rely on for preventing pregnancy.

April is STD Awareness Month

With so many months and even weeks dedicated to disease, causes, or remembrances, it can be easy to let them pass unrecognized. But we here at Rewire thought it was important to remind our readers that April is STD Awareness Month, because the epidemic in this country is growing out of control. For the first time in a decade, cases of chlamydia, gonorrhea, and syphilis are all on the rise.

Syphilis—a disease that not long ago, we thought could be eradicated—has increased by 40 percent between 2010 and 2014. While much of this increase is seen in men who have sex with men, rates among women are increasing as well. There has also been an increase in cases of ocular syphilis, which infects the eyes and can cause permanent blindness.

Along with this, we have seen a rise in the rate of congenital syphilis, which occurs when an infected woman passes the bacteria to her infant. As Rewire reported, the rate of congenital syphilis increased 38 percent between 2012 and 2014. Congenital syphilis can cause miscarriage, stillbirth, severe illness in the infant, and even early infant death. There were 438 nationwide cases of congenital syphilis in 2014, which led to 25 stillbirths and eight deaths within 30 days of birth.

Rewire has also been reporting on the possibility of antibiotic-resistant strains of gonorrhea that could turn a once easy-to-treat bacterial infection into a very dangerous disease.

We really do need to be aware of STDs and take steps to prevent them in ourselves and our communities. The CDC has given us all three easy tasks for this month—Talk, Test, Treat. So, for April, let’s talk openly about STDs with our friends, relatives, and partners; get tested if we’ve been exposed to any risk; and of course, seek treatment if necessary.

Analysis Contraception

Three Infertile Baboons May Mean We’re One Step Closer to Male Birth Control

Martha Kempner

Vasalgel, a new method of birth control currently in development, could block the vas deferens and prevent sperm from ever being ejaculated. A new study on baboons suggests the product works, but we've been promised male birth control before to no avail.

The Parsemus Foundation announced this week that it is one step closer to a birth control option for men after mating tests proved three baboons injected with Vasalgel, a polymer gel, remained infertile after six months.

A successful study of the product in rabbits was completed last year and the research team says baboons are the last stop before hopefully pulling together a clinical trial in humans. There remain numerous hurdles for the company and the product—both technical (determining fertility in a baboon is harder than it looks) and financial.

Male contraception (other than the condom) has been “just around the pharmaceutical corner” for decades, but one has yet to come to market. Scientists are looking at a number of ideas to temporarily halt fertility in men, but there have been problems with each of them.

The most frequently discussed is a hormonal contraceptive that would interrupt testosterone production and stop the testes from making sperm. Since testosterone has other functions, men would have to take some kind of limited testosterone supplement at the same time. Another idea in development blocks retinoic acid, which is important for sperm development, though research hit a snag when men who tried one such drug became sick if they drank alcohol.

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Other research has tried to disrupt sperm maturation so that they would not be functional or able to fertilize an egg, reduce the mobility of sperm so they could not reach the egg, or halt sperm production by using ultrasound to heat the testes—a procedure that would have to be done every few months.

Vasalgel is most similar to something called Risug (reversible inhibition of sperm under guidance), which has been in development in India for more than a decade. The idea is to inject a polymer gel into the vas deferens in order to block the path of the sperm, which use these tiny tubes to travel from the testes to the urethra and ultimately out of the penis during ejaculation.

This is the same basic concept behind male sterilization, also known as a vasectomy, in which doctors sever the vas deferens. The difference is that the gels are easily reversible. If a man wishes to have his fertility restored, his doctor can inject another substance into the scrotum that flushes out the vas deferens, once again clearing the path for sperm. Though the two gels are based on this same concept, the makers of Vasalgel say the formulations are different.

Last year, researchers declared that Vasalgel successfully blocked sperm in rabbits. Now they note that three male baboons who had the gel in place for more than six months remained infertile, which was determined by placing them in an enclosure with 10 to 15 female baboons and checking for any pregnancies.

The males were tested for fertility prior to the start of the study in a similar way. That time, pregnancies were considered good news. It is unclear whether the female baboons were also tested for fertility or if the sheer number of females was used as a way to guard against one or two infertile ladies in the bunch.

The research team explained that this mating method of proving or disproving fertility is being used because of issues with sperm collection. In a human trial, men would be asked to provide a semen sample to prove there were no longer any viable sperm, much like they are asked to do a few weeks after a vasectomy. In the rabbit study, the research team reported easily being able to collect semen so long as they provided a female rabbit to excite the males. But collecting semen from a baboon is apparently more complicated.

Researchers used “a device with mild electric currents [that] stimulates the nerves near the prostate gland, which creates contraction of nearby muscles—and ejaculation.”

Though this is common in animal studies, it turned out that the device or the electrical currents dislodged the gel and caused fertility to return in some of the baboons. The team is starting with a new group of four male baboons and going back to proof-by-mating.

Despite this complication, the Parsemus Foundation believes the baboon trials to be a success because three of the baboons from the original study remain infertile after more than six months. The next step for these three subjects is to remove the gel and see if their fertility returns.

The other good news for the researchers came in the form of a $50,000 grant from the David and Lucile Packard Foundation to support the baboon study. The Parsemus Foundation has funded this project through donations and crowd-sourcing, but says that it is still short of the money needed to complete this study.

Funding is widely expected to remain a primary obstacle in getting male birth control around that pharmaceutical corner.

It takes a lot of money to go from concept to contraceptive, and before they will invest in research and development companies want to know they’ll make a lot more money once the product is on the market. This is the all-important question that researchers, pharmaceutical companies, and public health experts have been grappling with for years. Are men really interested in taking responsibility for birth control?

And, in this case, will they still be interested when they learn it comes in the form of a scrotal injection?

The Parsemus Foundation says that we could know as soon as 2017, which is when it predicts (if all goes well) the gel would become available, but that seems optimistic as none of this research has yet been published in peer-reviewed journals (results of the rabbit study is expected to be officially published this year) and researchers haven’t yet moved from monkeys to men.