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Tue 23 Apr, 2019 06:40 am
PUBLIC RELEASE: 25-MAR-2019
Second potential male birth control pill passes human safety tests
THE ENDOCRINE SOCIETY
NEW ORLEANS--A new male birth control pill passed tests of safety and tolerability when healthy men used it daily for a month, and it produced hormone responses consistent with effective contraception, according to researchers at two institutions testing the drug. The phase 1 study results was presented Sunday, March 24 at ENDO 2019, the Endocrine Society's annual meeting in New Orleans, La.
The experimental male oral contraceptive is called 11-beta-methyl-19-nortestosterone dodecylcarbonate, or 11-beta-MNTDC. It is a modified testosterone that has the combined actions of a male hormone (androgen) and a progesterone, said the study's co-senior investigator, Christina Wang, M.D., Associate Director, Clinical and Translational Science Institute at Los Angeles Biomed Research Institute (LA BioMed), Torrance, Calif.
"Our results suggest that this pill, which combines two hormonal activities in one, will decrease sperm production while preserving libido," Wang said.
The study took place in 40 healthy men at LA BioMed and the University of Washington in Seattle, Wash. Ten study participants randomly received a placebo capsule, or dummy drug. The other 30 men received 11-beta-MNTDC at one of two doses; 14 men received 200 milligrams, or mg, and 16 got the 400 mg dose. Subjects took the drug or placebo once daily with food for 28 days. The Eunice Kennedy Shriver National Institute of Child Health and Human Development, which is developing 11-beta-MNTDC and other male contraceptives, funded this study.
Among men receiving 11-beta-MNTDC, the average circulating testosterone level dropped as low as in androgen deficiency, but the participants reportedly did not experience any severe side effects. Wang said drug side effects were few, mild and included fatigue, acne or headache in four to six men each. Five men reported mildly decreased sex drive, and two men described mild erectile dysfunction, but sexual activity was not decreased, she said. Furthermore, no participant stopped taking the drug because of side effects, and all passed safety tests.
Effects due to low testosterone were minimal, according to co-senior investigator, Stephanie Page, M.D., Ph.D., Professor of Medicine at the University of Washington School of Medicine, because "11-beta-MNTDC mimics testosterone through the rest of the body but is not concentrated enough in the testes to support sperm production."
Levels of two hormones required for sperm production dropped greatly compared to placebo, the researchers found. The drug effects were reversible after stopping treatment, Wang noted.
Because the drug would take at least three 60 to 90 days to affect sperm production, 28 days of treatment is too short an interval to observe optimal sperm suppression, Wang explained. They plan longer studies, and if the drug is effective, it will move to larger studies and then testing in sexually active couples.
"Safe, reversible hormonal male contraception should be available in about 10 years," Wang predicted.
Wang said most men are open to using this type of male birth control. She cited a multinational survey of 9,000 men published in the journal Human Reproduction in February 2005 that found that 55 percent of men in stable relationships want to try new, hormonal male contraceptive methods if they are reversible.
This experimental contraceptive, 11-Beta-MNTDC, is a "sister compound" to dimethandrolone undecanoate, or DMAU, the first potential male birth control pill to undergo testing by the same research team. Their results were published February 1, 2019 in The Journal of Clinical Endocrinology and Metabolism.
"The goal is to find the compound that has the fewest side effects and is the most effective," Page said. "We are developing two oral drugs in parallel in an attempt to move the [contraceptive medicine] field forward."
@neptuneblue,
This is great news! This will be a great advance in men's reproductive Rights.
@neptuneblue,
he said DR WANG. I wonder if its a "morning after pill"??
I suspect more than a few unwanted pregnancies will occur; women have been known to lie about being on birth control. Men now have the ability to lie about being on birth control as well. Such social progress!
@hightor,
If someone, male or female, wishes to ensure that they do not become a parent in the case of the other person lying, they can take birth control too.
If someone chooses to not take birth control, and becomes a parent because of it, not taking birth control was their own choice.
@hightor,
hightor wrote:
I suspect more than a few unwanted pregnancies will occur; women have been known to lie about being on birth control. Men now have the ability to lie about being on birth control as well. Such social progress!
This is silly.
I have never known a unmarried man who wanted to get a woman pregnant. I don't think you have either.
Male pill - why are we still waiting?
By Michelle Roberts
Health editor, BBC News online
26 March 2019
A birth control pill for men has passed initial human safety tests, experts at a leading medical conference have heard.
The once-daily pill contains hormones designed to stop sperm production.
It would be a welcome addition to condoms or vasectomy - the only options currently available to men.
But doctors at the Endocrine Society's annual meeting were told it could still take a decade to bring it to market.
Sex drive
The female pill was launched in the UK more than 50 years ago. So why is a male pill proving so difficult?
Some say there has been less societal and commercial will to get a male pill off the ground - but opinion polls suggest many men would consider taking it if a pill did become available.
Whether women would trust men to reliably take it is another issue.
A UK survey by Anglia Ruskin University, in 2011, found 70 out of 134 women would worry that their male partner would forget to take a pill.
Biologically, the challenge of creating a hormone-based pill for men is making sure that it doesn't blunt sex drive or reduce erections.
Sperm production
In fertile men, new sperm cells are constantly made in the testicles, triggered by hormones.
Temporarily blocking this effect without lowering hormone levels to such an extent that it creates side-effects is the issue.
But this latest male pill, being tested by researchers from LA BioMed and the University of Washington, should hopefully achieve this goal, researchers say.
Image copyrightGETTY IMAGES
Initial "phase one" safety tests with 40 men looked promising, they told the Endocrine 2019 meeting in New Orleans.
For the 28 days of the study:
10 took a placebo, or dummy pill
30 took the experimental male pill, 11-beta-MNTDC
And among those taking the androgen-based drug, levels of hormones required for sperm production dropped greatly compared with placebo, returning to normal after the trial.
Erectile dysfunction
Side-effects, meanwhile, were few and mild.
Five men on the pill reported mildly decreased sex drive - and two described mild erectile dysfunction - but sexual activity was not decreased, no participant stopped taking it because of side-effects and all passed safety tests.
The researchers behind the work, Prof Christina Wang and colleagues, are excited but cautious about the findings.
"Our results suggest that this pill, which combines two hormonal activities in one, will decrease sperm production while preserving libido," she said.
But bigger, longer trials were needed to check it would work well enough as a birth control.
Body gel
And this is not the only prototype hormone-based male contraceptive Prof Wang has been testing.
She and colleagues have come up with a body gel men in the UK will be trying as part of an international trial.
Users apply it daily to their back and shoulders, where it can be absorbed through the skin.
Progestin hormone in the gel blocks natural testosterone production in the testicles, reducing sperm production to low or nonexistent levels, while replacement testosterone in the gel maintains sex drive and other functions that rely on the hormone.
Meanwhile, Prof Wang, Dr Stephanie Page, and colleagues at the University of Washington School of Medicine, have been testing another compound - DMAU - that they believe men could take as an oral daily contraceptive pill.
And trials in 100 men have suggested this is safe enough to move into the next phase of testing.
Mood disorders
Other scientists have been trying delivering longer-acting birth control hormones in a jab given every other month.
But they stopped enrolling men to their phase-two study, looking at the safety and effectiveness of the injection, after some of the volunteers reported side-effects, including mood disorders or depression.
For men who don't fancy taking hormones, researchers have been looking at ways to block sperm flow, stopping it from ever leaving the penis - effectively, a non-surgical vasectomy.
Vasalgel - a polymer material that is injected into the two ducts that transports sperm from the left and right testicles to the penis - is being developed as a non-hormonal, reversible, long-acting male contraceptive.
So far, it has been tested in animals only - but the researchers behind it have recently received funding to look to begin human trials.
Potential market
Prof Richard Anderson, of the University of Edinburgh, is leading one of the UK trials that will test a contraceptive body gel on men.
He said the pharmaceutical industry had been slow to get behind the idea of a new male contraceptive despite good evidence that both men and their female partners would welcome the additional choice.
"I think that industry has not been convinced about the potential market," he said.
"It's certainly been a long story - part of it is lack of investment."
Chequered history
With little industry involvement, he said, researchers had had to rely on charitable and academic funding, which took time.
Allan Pacey, professor of andrology, at the University of Sheffield, said: "The development of a male birth control pill, or injection, has had a chequered history without much success so far and so it is good to see that new preparations are being tested.
"The key will be if there is enough pharmaceutical company interest to bring this product to market if their trials are successful.
"Unfortunately, so far, there has been very little pharmaceutical company interest in bringing a male contraceptive pill to the market, for reasons that I don't fully understand but I suspect are more down to business than science."
Comments
This entry is now closed for comments.
Comment number 231. Posted by Luke95 on
27 Mar 2019 16:32
People saying men are untrustworthy. Firstly as a male I can say I have always kept the mantra, if its a one off and she says she's on the pill, then bag up as she could be lying. Secondly, If a female does get lied to as I'm sure they will, they have a way out with abortion. I know it's horrible but there's the option. Vice versa and the girl wants to keep the baby, the man is TRAPPED.
Comment number 230. Posted by strider on
27 Mar 2019 16:00 7. KH
" It truly saddens me that my son will be brought up in a world where he can be freely admonished due to his gender." Don't worry he's used to it by now, all CBBC and Cbeebies output has males as the dumb, clumsy (sometimes lovable) oafs being saved by the clever females.
Comment number 229. Posted by Paul on
27 Mar 2019 14:36
Men would love to have the opportunity to secretly control conception in the same manner that women have enjoyed. It would give men some control; my body my choice. I’m rather surprised that this was written by a female. Such articles written by men of female issues often meet with negativity for reasons of differing life experiences. Surely the same applies here?
Comment number 228. Posted by Pragmatist on
27 Mar 2019 13:31
Pregnancy might be the worst STI. But it's not the only one.
Comment number 227. Posted by MadAboutMints on
27 Mar 2019 13:22
Dr Wang! Lol. Just me? Nominative determination at its very best. :-)
Comment number 226. Posted by drHoo on
27 Mar 2019 12:41
"A few folks here referring to “the trap”. Sex equals potential pregnancy, we all know this. Responsibility lays with both." Very true and "the trap" goes beyond pregnancy for men. There's very little benefit for men (these days) to have long-term/romantic relationship with women. IF and I really mean big IF sex happens very occasionally when women are in the mood, the cost is way too high!
Comment number 225. Posted by Wasting Time on
27 Mar 2019 12:16
'A UK survey by Anglia Ruskin University, in 2011, found 70 out of 134 women would worry that their male partner would forget to take a pill.'
Wow, the stats for that are fantastic.. They asked a sample size of insignificant proportion, most likely people who know students at the university, so are likely to be of similar age and the best part of a decade ago...
Comment number 224. Posted by Megan on
27 Mar 2019 11:33
After reading this article, I expected the comments section to be filled with sexist bibblings from both men and women... ... and I have not been disappointed.
Comment number 223. Posted by M - O - T on
27 Mar 2019 11:13
Whether women would trust men to reliably take it is another issue. For goodness sake, how many men have been trapped by trusting a woman?
Comment number 222. Posted by Hugh Oxford on
27 Mar 2019 10:29
Pumping powerful hormones into healthy people so that their reproductive system doesn't function isn't medicine or healthcare, and it's disgraceful that it's marketed as such. Leaving aside the ethics of recreational contraception, why are taxpayers required to pay for it under the banner of "healthcare"? If you want to attempt sterile sex, then that's your problem, it shouldn't be mine.
Comment number 221. Posted by Yo on
27 Mar 2019 09:46
Math and sex: Don't have number so just assumptions
Pill (male and female) failure 1% (0.01)
Condoms failure 20% (0.20)
sex: 3 times a month (= 1 a week)
Only female pill: 1 out of 100 sex = 1 child -> so 1 every 3 years
female pill and condom: 1 out of 500 sex = 1 child -> so 1 every 15 years
male and female pill: 1 out 10.000 sex = 1 child -> so 1 every 300 years
Comment number 220. Posted by acs_consult on
27 Mar 2019 08:32
It’s not a gender balanced issue as the consequences of unplanned pregnancy affect all women but not necessarily all men - sometimes a man isn’t even told! In a long term relationship built on trust a male pill could be a good choice. I know women who have decided they want a baby and manipulated the situation so they get pregnant. In the end it’s a personal responsibility for your own fertility.
Comment number 219. Posted by inchindown on
27 Mar 2019 07:52
Just put carpet tacks in his shoes. That'll make him limp. Simples.
Comment number 218. Posted by Micah William on
27 Mar 2019 01:42
The above is quite interesting; but like anything else; I would like to be reassured about the long-term side effect: especially on the male sexual organs.
Comment number 217. Posted by j_reynolds on
27 Mar 2019 00:57
Men need to have more contraceptive options or, failing that, as suggested by Peter Lloyd, reproductive rights that give them the ability to separate themselves financially from a child they never consented to have.
Comment number 216. Posted by j_reynolds on
27 Mar 2019 00:54
"Whether women would trust men to reliably take it is another issue." A classic radical feminism-infested, collectivist, sexist statement that implies women have a reason not to trust men because only women can do good and only men can do bad. Women have forgotten to take the pill or committed the crime of conception by deception, e.g. Amanda Holden.
Comment number 215. Posted by U17599473 on
27 Mar 2019 00:22
Not seen anything on the topic for a while but last time this was brought up a few years back and I’ll stay say it’s good thing just like I did then. For the people talking about trust, sex is a reproductive act, don’t do it “willy nelly” eh eh. No option is 100% so the more routes to safety the better.
Comment number 214. Posted by BE on
26 Mar 2019 23:55
This isn’t a good product, hence no one wanting to push it. Anything stopping sperm production is going to have a serious effect somewhere down the line. The bodys testes will shrink with no testosterone producing sperm. That’s an unnatural suppression of sperm from creation. Makes sense when those on hormone treatment take it to create sperm. So go work out the difference people. Easy? Not good!
Comment number 213. Posted by thanks for all the fish on
26 Mar 2019 23:18
A few folks here referring to “the trap”. Sex equals potential pregnancy, we all know this. Responsibility lays with both.
Comment number 212. Posted by DayOfReckoning on
26 Mar 2019 23:07
This would be great. It's an extra check against bringing an unwanted child into the world and means both parents have to want the child. Men would no longer be able to avoid responsibility. That is probably why there's less interest in it, why it doesn't already exist. Men who are willing to put women on the pill to avoid kids but not take one themselves should keep their hands etc to themselves.