Pill Pushing©

Beyond the condom - The male's role in birth control - (4/1/2018)

By Dr. Ron Gasbarro

Male contraceptives, also known as male birth control, are methods of preventing pregnancy that work primarily on the male physiology. The most common kinds of male contraception include condoms, withdrawal or pulling out (coitus interruptus), outercourse, and vasectomy. All of them have their disadvantages. But there are some surprises for 2018!

An introduction to the “rubber”
Condoms as a method of preventing STIs have been used since at least 1564 [Hatcher, 2007]. Rubber condoms become available in 1855, followed by latex condoms in the 1920s [McKibbin, 2000]. They are on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system [WHO, 2015]. 

Due to the Comstock Law of 1873 (Suppression of Trade in, and Circulation of, Obscene Literature and Articles of Immoral Use) and many similar state laws, condoms were strictly sold as protection against disease. Even after the Comstock Law expired in 1957, many pharmacists were unwilling to stock a product associated with sexual vice. For that reason, consumers often had to purchase their condoms in the backrooms of bars and from the vending machines in the restrooms of gas stations. 
 
Is the condom the ideal contraceptive for the male?
In the 1950s, guys carried around a prophylactic (AKA: rubber) in their wallets just in case they got “lucky.” By the 1960s, birth control pills happened and the sexual revolution went off with a literal bang. The need for condoms was not a necessity for the prevention of pregnancy. By the 1980s, AIDS knocked the wind out of syphilis and gonorrhea since these diseases could be cured with penicillin while AIDS was, at the time, fatal. Shortly after, condoms came out of the wallet and into the print and TV media: Different colors, sizes, and even shapes if you count the female condom. Yet, men would still rather go bareback when they have intercourse, particularly if the woman was on birth control.

Men do not like to wear condoms because it mutes some of the sexual sensation, although newer models are ultra-thin. Yet, another problem is that while trying to slip it on, the change of focus is a major distraction for them. When a couple is in the midst of the sexual act, diverting from it to do something decidedly unromantic is not desirable by the man. Yet, many men them to protect from sexually transmitted diseases (STDs) or unwanted pregnancy. 

A study done at the Department of Health Behavior at the University of Alabama at Birmingham revealed that, rather than wear a condom, men prefer to take a chance in a fit of excitement [Grimley, 2004]. The safety a condom provides in preventing from STDs is not compelling enough for them to be strict about wearing prophylactics. They would rather do it and face the consequences later, according to the study.

However, for those men who are in a monogamous relationship with a woman who uses birth control, a condom is typically not used. But what if the woman in the relationship cannot or prefers not to use hormone-based contraception? Is there anything other than the condom for men to use?

Thinking beyond the condom
Presently, only two types of male contraceptives are available: the condom, which provides non-permanent prophylaxis, and vasectomy, which is both challenging to overturn and, if possible, results in low fertility rates following reversal surgery [Herrel, 2015].    

Vas-occlusion contraception
The vas deferens is a pair of tubes that transport sperm from the epididymis to the ejaculatory ducts. During a vasectomy, the vas deferens is permanently severed. Vas-occlusive contraception is a form of male contraception that blocks sperm transport in the vas deferens. Various vas-occlusive contraceptive methods have been researched for human-use, with interest in both reversible and irreversible methods. The purpose of this research is to find a suitable alternative to vasectomy and possible hormonal contraceptive treatments. 

One such approach is the Echo-VR™(Contraline, Charlottesville, VA). Rather than cutting the tubes, Echo-VR is a solution implanted into the vas deferens through an ultrasound-guided procedure known as vasintomy which is done by a urologist [Contraline, 2017]. The solution becomes a sturdy hydrogel gel within seconds and remains within the vas deferens without compromising the male reproductive tract. The gel prevents sperm from flowing through the vas deferens. The lining of the vas deferens degrades and absorbs the sperm. The gel is non-hormonal so there will be no systemic side effects like weight gain and acne that come with female steroidal options. In the past, there have been gels or devices implanted into the vas deferens. Some of them cause scarring of the vas tissue. A granuloma, a tissue mass typically produced in response to infection, inflammation, or the presence of a foreign substance, can form if the urologist misses and injects into the smooth muscle layer, and foreign body responses can occur if the gel is not biocompatible, which means it can harm living tissue. Echo-VR gel is biocompatible and cannot damage viable tissue. The vasintomy procedure allows the urologist to see the lumen so it reduces and potentially eliminates the chance for granulomas. Vasinotomy can be reversed by injecting a solution that turns the gel back into a liquid, which can then be eliminated. Echo-VR is currently in clinical trials. 

Vasalgel™ (Parsemus Foundation, Berkeley, CA) is another long-acting, non-hormonal contraceptive that is, like Echo-VR, more reversible than vasectomy [Parsemus Foundation, 2018]. The procedure is similar to a no-scalpel vasectomy, except a gel is injected into the vas deferens, rather than cutting the vas as is done in vasectomy. If a man wishes to restore the flow of sperm, whether after months or years, the polymer is flushed out of the vas deferens with another injection.

A study was performed on a non-human primate model to evaluate the efficacy Vasalgel [Colagross-Schouten, 2017]. Vasalgel placement within the vas deferens appears to be an effective method for contraception in adult male rhesus macaques living in social group settings. Placement prevented conception and was durable throughout the observation period in all animals, which covered as long as two full breeding seasons in some animals. Additionally, the presence of Vasalgel appears to be well tolerated and placement resulted in minimal complications. This product will be headed to human clinical trials in the near future.

An oral contraceptive for men 
Even though “the pill” has been available to women for over 60 years, the guys have never had such an option. And, over the decades, researchers have certainly tried to create such an alternative contraception method for men.

One of the main pathways to male birth control is the hormonally-based pill. It uses a combination of testosterone and progestin, which turn off signals from the brain to the testes. However, this causes significant side effects like low libido, depression, and can affect a man's masculinity or sexuality. Also because digestion breaks down testosterone, a combination pill could not hold enough testosterone to be effective at reversing the effects of the progestin.

Because of the challenges of creating a hormonally-based male birth-control pill, researchers are looking into non-hormonal methods to lower sperm count or somehow disable the sperm so that they cannot fertilize an egg. One answer may be found in the research halls of King's College London, UK. There, researchers have isolated a chemical that stops the vas deferens from contracting and pumping sperm from the testicles out of the penis (ejaculation). Animal studies and human studies are yet to take place. 

If a male birth-control pill does become a reality, two questions surround its possible use:
1. Will men take it?
2. Will women trust them to take it?

The answer to both the questions would was “yes”. In a survey by the Kaiser Family Foundation, 66% of American men said they would be willing to try the new pill [Kaiser Family Foundation, 1997]. And in an international survey of 4,000 men and women, about 66% of male respondents said they would use a birth control pill if it were available; 75% of the women said they would trust their partner to handle the birth control [BBC News, 2000]. While women may be more than happy to pass on the buck to their male counterparts to take the responsibility of fertility, what women fear is their inability to remember to take a pill. Polls have repeatedly shown wives and partners do not trust their men to remember to pop a pill every day, whether it is a vitamin or a blood pressure pill, let alone a birth control pill.

More recent surveys, however, suggest interest has dwindled. Although a majority of adults see contraception as a joint responsibility, not as many men are hyped about male birth control. In 2005, 55% of 9,000 male survey respondents said they were interested in a “new male fertility control” [Goodman, 2005]. In another 2008 survey, 36% of men said they would take a hormonal birth control, possibly indicating that men are growing weary of the wait-and-see for male birth control options [Medical News Today, 2008]. At this point in the decades-long pursuit of an effective, reversible male birth control with minimal side effects, a more relevant survey might focus on the odds of a successful contraceptive treatment ever hitting the market at all.

But wait! It is 2018 and there is news on the horizon. 
A new birth control pill for men appears to be safe when used daily for a month, with hormone responses consistent with effective contraception, study researchers say [Endocrine Society, 2018]. Their study results in 83 men were presented at ENDO 2018, the Endocrine Society's 100th annual meeting in Chicago. Like the pill for women, the experimental male oral contraceptive – called dimethandrolone undecanoate, or DMAU – combines activity of an androgen (male hormone) like testosterone, and a progestin, and is taken once a day, said the study's senior investigator, Stephanie Page, MD, PhD, professor of medicine at the University of Washington in Seattle. 

Progress toward a male birth control pill has been stymied because, according to Page, available oral forms of testosterone may cause liver inflammation, and they clear the body too quickly for once-daily dosing, thus requiring two doses a day. However, DMAU contains undecanoate, a long-chain fatty acid, which Page said slows this clearance. Additional studies are currently underway to confirm that DMAU taken every day blocks sperm production.

After more than a decade of work, government researchers in the US are ready to test an unusual birth control method for men—a topical gel that could prevent the production of sperm. And no, you do not rub it on your genitals. It is massaged on the upper arms and shoulders — and just a half of teaspoon of gel is said to do the trick. The clinical trial, which begins in April 2018 and will run for about 4 years, will be the largest effort in the US to test a hormonal form of birth control for men.

In the last major study of a hormonal male contraceptive, which took place in Europe from 2008 to 2012, participants received injections of hormones every 2 months. The shots suppressed sperm production and prevented the men’s female partners from getting pregnant, but they also gave men severe mood swings and other serious side effects. The new gel contains 2 synthetic hormones, testosterone and a form of progestin. Progestin blocks the testes from making enough testosterone to produce normal levels of sperm. The replacement testosterone is needed to counteract the hormone imbalances the progestin causes but will not make the body produce sperm. The gel can suppress sperm levels for about 72 hours, so if men forget a dose, there is a bit of forgiveness.

Still, the question remains: Will men use it?

Ron Gasbarro, PharmD, is a registered pharmacist, medical writer, and principal at Rx-Press.com. Read more at www.rx-press.com 

References 
BBC News. "Most Men 'Would Take the Pill.’” Feb. 23, 2000. http://news.bbc.co.uk/1/hi/health/652279.stm. 

Colagross-Schouten A, Lemoy MJ, Keesler RI, Lissner E, VandeVoort CA. The contraceptive efficacy of intravas injection of Vasalgel™ for adult male rhesus monkeys. Basic Clin Androl. 2017 Feb 7;27:4. doi: 10.1186/s12610-017-0048-9. 

Endocrine Society, The. "Dimethandrolone undecanoate shows promise as a male birth control pill." ScienceDaily. ScienceDaily, March 18, 2018.
 
Goodman, A. “The Long Wait for Male Birth Control.” TIME. Aug. 3, 2008.  http://www.time.com/time/health/article/0,8599,1829107,00.html 

Grimley DM, Hook EW 3rd, DiClemente RJ, Lee PA. Condom use among low-income African American males attending an STD clinic. Am J Health Behav. 2004;28:33-42.

Hatcher RA, Nelson AL. Contraceptive Technology.New York, NY: Ardent Media, Inc.; 2007; p. 297-311. 

Herrel LA, Goodman M, Goldstein M, Hsiao W. Outcomes of microsurgical vasovasostomy for vasectomy reversal: a meta-analysis and systematic review. Urology. 2015;85:819–25.

Kaiser Family Foundation. “A New National Survey on Men’s Role in Preventing Pregnancy: Women and Men Think Men Need to Be More Involved in Contraceptive Choice and Use.” March 19, 1997. 
http://www.kff.org/womenshealth/loader.cfm?url=/commonspot/security/getfile.cfm&PageID=14510 

McKibbin R. Classes and Cultures: England 1918-1951. Oxford, UK: Oxford University Press; 2000; p. 305. 

Medical News Today. “Revealed: Men’s Attitudes to Contraception, FPA Publishes Results of National Survey, UK.” Feb. 11, 2008. http://www.medicalnewstoday.com/releases/96645.php 

WHO Model List of Essential Medicines (19th List). Geneva, Switzerland: World Health Organization. April 2015.


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