More than half a century later, where’s the male pill?
In 1940s India, Dr. Marthe Voegeli made a potentially world-changing discovery: that exposing the testicles to hot water baths at temperatures of 116 degrees Fahrenheit for 45 minutes every day for three weeks provided six months of reliable contraception.
She carried out a series of experiments showing that men could achieve varying lengths of contraceptive effectiveness from these hot baths. Getting men to take part in her research in the 1940s and '50s was no mean feat for a woman of her time, and she only managed to recruit dozens of men to her trials, however. That's far short of the hundreds and thousands who would be required to take part in a meaningful trial nowadays.
Despite this, Voegeli's preliminary results were promising. Yet the aims of her research were soon forgotten. Why? The female hormonal contraceptive pill was approved by the FDA in 1960, and interest in her work waned as the quest for non-intrusive, reliable contraception was deemed by many to have been realized.
It is now more than half a century since The Pill revolutionized our sex lives, our family lives, and, in many ways, women's bodies. Today, there are 17 female-controlled forms of contraception approved by the FDA, including the birth control pill. Yet condoms and vasectomies are all that is available to men and couples who would prefer that men shoulder some of the contraceptive burden.
You would think that, today, with so few male contraception options, the case for a male pill would be clear. The potential market alone is pretty big and should be enticing.
“[The market is] half the population that is having sex, when they don’t want to have a pregnancy or they want to time their pregnancy,” points out Male Contraceptive Initiative Executive Director Dr. Aaron Hamlin.
Beyond potential profit, a recent study done by the Initiative and published by the journal Contraception in January 2018 showed that up to 180,000 unwanted pregnancies could be avoided each year in the US alone if a male pill were to become available. At the time, the MCI wrote that the real-world pregnancy rate even for condom use stands at 13 percent; meanwhile nearly 50 percent of the 9,000+ men surveyed in this recent study said they’d be 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, those are assumptions evidence doesn’t back up, Hamlin argues. It makes the familiar, still lingering question all the more frustrating and confusing.
What’s taking so long? Where is the male pill?
When you recognize there is a collective desire for a male contraceptive breakthrough, it makes the failure of science to deliver one to date even more baffling. Interestingly, the problem is rarely with the drugs themselves, as recent developments have been shown to have contraceptive efficacy. Instead, it’s barriers to bringing a male pill to market that remain myriad and complex.
In 2016, it was reported that one of the most promising projects, a trial of a contraceptive injection that worked by reducing the sperm count of men, had been called off due to safety fears. Though some headlines at the time may have sneered at the side effects listed being comparable to those most women using hormonal birth control are expected to endure (such as mood problems or low libido), arguably fears at the time were in fact well founded.
One participant is thought to have taken their own life and one other attempted to do so during the trial. A total of 20 men dropped out of the trial due to the impact on their mood, and other side effects such as acne, pain, and erectile dysfunction surfaced.
Despite this, the study, which was run by the World Health Organization (WHO) and co-funded by the CONRAD Project, showed that the dual injection of norethisterone enanthate (Net-En) combined with testosterone undecanoate (TU) worked for 96 percent of couples, and 75 percent of the participants said they would continue to use it if it became available.
Professor Richard Anderson, Elsie Inglis Professor of Clinical Reproductive Science at Edinburgh University, worked on the project and says he felt that the decision to end the trial was questionable.
“There were concerns over safety, it was a debatable position, and the trial management committee wanted to carry on, but a different committee at the WHO wanted to stop it,” he reveals. “Big issues relating to the side effects meant we couldn’t continue with the trial, but a lot of data had already been collected at that stage, which demonstrated the primary outcome [of contraceptive efficacy]. The trouble is, with the WHO, things move at a geological pace, due to their lack of funding, so I am not aware that they have any plans to be pursuing the area further.”
Despite the cancellation of the trial, Anderson considers the trial to have been a success with regard to demonstrating that the drugs did work. But this wasn’t the first time that hormonal contraception has been developed for men. In fact, research has been focused in this area for years.
A promising alliance to create a male pill was formed back in 2002 between two of the biggest pharmaceutical players in the contraceptive and hormonal markets: Organon and Schering. Organon was the biggest producer of the contraceptive pill in Europe, and Schering was responsible for the production of the best synthetic testosterone on the market, Nebido.
The two pharma giants reported at the time that they were “optimistic to fill this gap” for male contraception “in the future." They joined forces to start a phase II multicenter trial in 2002, though they were clear that the pursuit of a new contraceptive would be, as always, a lengthy process. They estimated it would take another five to seven years to get a drug to market.
The trials they undertook were based on using Organon’s etonorgestrel implant with injections of Schering’s testosterone undecanoate. These trials started in 2004 but were canceled in 2006 when the two companies dissolved the partnership, planning, they said at the time, to continue research efforts separately. A study was published in 2008 showing that the contraception had been 91-percent effective in participants taking part in the trial, but this paper noted that side effects such as low mood were problematic.
Despite these promising results, Schering’s program stopped in 2007 when Bayer acquired Schering. Organon’s program stopped by 2009, when Merck bought Schering Plough, which acquired Organon in 2007.
“Organon manufactured a new type of Implanon (now known as Nexplanon) for men which gave a bigger dose than the female dose. So they were really putting some R&D into it as well as trial money, and then that all went away when Organon moved away from contraceptive developments,” says Anderson.
Two major pharmaceutical companies losing interest while in the pursuit of a male controlled form of contraception suddenly brought up another barrier to bringing a new drug to market: funding.