In 1940s India, Dr. Marthe Voegeli made a potentially world-changing discovery: that exposing the testicles to warm water baths at temperatures of 116 degrees Fahrenheit every day for three weeks for three weeks provided reliable contraception for six months.
She conducted a series of experiments that showed that men could achieve different lengths of contraception with these hot baths. Getting men to participate in her research in the 1940s and 1950s was no easy feat for a woman of her time, but she only managed to recruit dozens of men for her trials. That’s far less than the hundreds and thousands who would have to participate in a meaningful lawsuit today.
Nevertheless, the preliminary results of Voegeli were promising. Yet the aims of her research were quickly forgotten. Why? The hormonal contraceptive pill for women was approved by the FDA in 1960, and interest in its work waned as the quest for non-intrusive, reliable birth control was considered by many to be accomplished.
It’s now been more than half a century since The Pill revolutionized our sex life, family life and, in many ways, women’s bodies. Today, there are 17 female-controlled forms of birth control approved by the FDA, including the birth control pill. Still, condoms and vasectomies are the only thing available for men and couples who would rather men take on some of the birth control burden.
You would think that, with so few contraceptive options for men, the case for a male pill would be clear. The potential market alone is quite large and should be enticing.
“[The market is] half of the population who have sex when they don’t want to get pregnant or want to time their pregnancy,” emphasizes the director of the Male Contraceptive Initiative, Dr. Aaron Hamlin.
In addition to potential gains, a recent survey of the initiative and published by the journal birth control in January 2018 showed that in the US alone, up to 180,000 unwanted pregnancies per year could be avoided if a male pill became available. At the time, the MCI wrote that the real-world pregnancy rate, even before condom use, is 13 percent; meanwhile, nearly 50 percent of the more than 9,000 men surveyed in this recent survey said they were open to taking a male pill.
So while it’s common for people to claim that men don’t want it or even that their partners won’t trust them to take it, these are unsupported assumptions, Hamlin argues. It makes the familiar, still lingering question all the more frustrating and confusing.
Why does it take so long? Where is the male pill?
Recognizing that there is a collective desire for a breakthrough in male contraception makes the failure of science so far to deliver one even more baffling. Interestingly, the problem is rarely with the drugs themselves, as recent advances have shown they have contraceptive efficacy. Instead, the barriers to marketing a male pill remain numerous and complex.
In 2016, it was reported that one of the most promising projects, a trial of a birth control shot that worked by reducing men’s sperm count, had been shelved due to safety concerns. While some headlines at the time scoffed at the side effects listed for being similar to those of most women using hormonal birth control (such as mood problems or low libido), the fears were in fact well-founded at the time.
One participant allegedly committed suicide and another attempted to do so during the trial. A total of 20 men dropped out of the study because of its impact on their mood, and other side effects such as acne, pain and erectile dysfunction emerged.
Despite this, the study, which was conducted by the World Health Organization (WHO) and co-funded by the CONRAD project, showed that the double injection of norethisterone enanthate (Net-En) combined with testosterone undecanoate (TU) worked for 96 percent of couples. , and 75 percent of participants said they would continue to use it if it became available.
Professor Richard Anderson, Elsie Inglis Professor of Clinical Reproductive Science at the University of Edinburgh, worked on the project and says he found the decision to end the trial questionable.
“There were security concerns, it was a questionable position, and the commission of inquiry wanted to continue, but another commission at the WHO wanted to stop it,” he reveals. “Major issues related to the side effects prevented us from proceeding with the trial, but at that stage a lot of data had already been collected, demonstrating the primary outcome [of contraceptive efficacy]. The problem is with the WHO things are moving at a geological pace, due to their lack of funding, so I’m not aware they have any plans to explore the area further.”
Despite the trial cancellation, Anderson considers the trial a success in terms of demonstrating that the drugs do work. But this wasn’t the first time hormonal contraception for men was developed. In fact, research has been focused on this area for years.
A promising alliance to create a male pill was formed in 2002 between two of the largest pharmaceutical players in the contraceptive and hormonal market: Organon and Schering. Organon was the largest producer of the contraceptive pill in Europe and Schering was responsible for producing the best synthetic testosterone on the market, Nebido.
The two pharmaceutical giants reported at the time that they were “optimistic to fill this gap for male contraception “in the future”. Contraception would, as always, be a lengthy process. They estimated it would take another five to seven years to develop a drug on the market.
The trials they did were based on using Organon’s etonorgestrel implant with injections of Schering’s testosterone undecanoate. These trials began in 2004 but were canceled in 2006 when the two companies dissolved the partnership, with the plan, they said at the time, to continue the research efforts separately. A study was published in 2008 that found the birth control to be 91 percent effective in trial participants, but this article noted that side effects such as low mood were problematic.
Despite these promising results, Schering’s program ceased in 2007 when Bayer took over Schering. Organon’s program ended in 2009 when Merck bought Schering Plow, which Organon acquired in 2007.
“Organon produced a new type of Implanon (now known as Nexplanon) for men that gave a larger dose than the female dose. So they really put some R&D into it, as well as trial money, and that’s when Organon went off developing contraception,” Anderson says.
Two major pharmaceutical companies that lost interest while looking for a male-controlled form of birth control suddenly erected another barrier to bringing a new drug to market: funding.