Australian researchers have been working on a reversible and effective male contraceptive pill.
They developed a combination treatment - a hormonal implant of testosterone, which was given every four months, and a progestin, called DMPA, which was injected every three months.
The method was tested on 55 men over a 12-month period. No pregnancies occurred among their partners during that time.
The findings have been welcomed and experts say they provide the first steps for a practical and reversible male hormonal contraceptive.
More testing and development is required before the method becomes commercially available.
Male pill on the way?
Bupa investigative news - 13 October 2003
written by Rachel Newcombe, reporter for Bupa's Health Information Team
There are few types of male contraception currently available, but the future could hold better options, thanks to new research. Researchers in Australia have developed a combination treatment, using testosterone and progestin, which has so far proved effective in trials.
What were the headlines?
Details regarding the male contraceptive research appeared in most of the UK newspapers and news websites. Examples of headlines included "Men get 'Pill' jabs", "The risk-free pill for men", "Men on the pill? Yeah, right", "Male contraceptive pill proves 100 per cent effective in first trial" and "Male birth control pill successfully tested".
Coverage ranged from short reports of the discovery to lengthy investigations into the method and it's likely use.
What is the bigger picture?
The male contraceptive trial was conducted over a five-year period at the ANZAC Research Institute in New South Wales, Australia, and Prince Henry's Institute in Victoria. It was funded by an American family planning agency and details of the research are published in the October Journal of Clinical Endocrinology and Metabolism.
The first part of the trial was to develop a method of male contraception based on long-acting hormones that suppressed sperm production in a reliable and reversible way. They developed a technique that involved using an injection of the progestin called DMPA and an implant of the male sex hormone testosterone. The technique was found to be 95 per cent effective.
Due to the success of the first part of the trial, the researchers set up a second phase: a 12-month effectiveness trial. This involved giving 55 male volunteers an implant of testosterone every four months, and an injection of DMPA every three months. According to the team, this is the first time such a combination has been used in an effectiveness study. During the study no pregnancies occured among the volunteers' partners.
"This is the first time a reversible male contraceptive that will suppress sperm production reliably and reversibly has been fully tested by couples," said principal investigator, Professor David Handelsman of the ANZAC Research Institute. "We used a hormonal implant to replace testosterone given every four months and the progestin, DMPA, was injected every three months. This formula produced no pregnancies over the 12-month period."
At the beginning of the study the hormone levels had to be adjusted to ensure testosterone levels stayed normal but, after that, there were no problems or side-effects. All participants retained their normal energy and libido levels (some even found that their libido was increased).
According to Professor Handelsman, "This shows the way for a final product to be a single injection containing testosterone and progestin which will easily be given by local doctors on a 3-4 monthly basis and still maintain male sexual health."
He believes the study offers future hope for men by providing them with greater contraceptive choice. "The results of this study foreshadow how men may be able to take greater responsibility for contraception in a convenient and effective way. This is about providing people with choice. When couples are at different stages of their reproductive life, their needs differ. This is designed for couples in stable relationships where they negotiate their contraceptive needs and their desire for family and timing of children," he said.
He added that, "This is a very important study because it was the first to ever fully test an approach which could go forward into practical development. As researchers, we have done as much as is possible. It is now over to the companies to develop a convenient and acceptable product. We have proved that it is possible for them to do it."
"This could be really useful for stable couples, where the man would like to take responsibility for contraception but does not wish to have a vasectomy.
"It is reassuring that researchers were able to show that sperm production stepped back up after the end of the study. It would be interesting to know whether there were any pregnancies after the trial finished."
Dr. Virginia Warren,
assistant medical director,
Bupa Group
What does this mean?
Melissa Dear, spokesperson for the FPA (formerly known as the Family Planning Association), said, "The FPA welcomes this particular development. Anything which brings the reality of a male contraceptive - a pill or an implant - one step closer is very much to be welcomed by both women and men."
Tony Kerridge, spokesperson for Marie Stopes International (MSI), also welcomed the development. "Marie Stopes International certainly feels that it is an important development. We generally tend to welcome all new contraceptive developments, providing they're proven to be safe and effective, because they broaden the choices available. Any method that can encourage greater involvement from men is to be particularly welcomed."
He added that, "Our own take on this is that it would probably be better suited to couples who are in committed loving relationships, married or not, where they've negotiated and discussed it between themselves, rather than for individuals, as there's a question of trust."
This isn't the first time a male contraceptive pill has been investigated. Research first began more than 25 years ago and the World Health Organisation (WHO) carried out two major studies in the 1980s and 1990s. In addition, other organisations are currently developing their own versions of male hormonal contraception: scientists at Edinburgh University are using a similar implant method and a number of pharmaceutical companies developing their own products.
If you need information about contraceptive methods, talk to your GP or visit a family planning clinic.
The current contraceptive methods for men are condoms and vasectomy.
Available contraception for women includes the pill, patch, implants, diaphragms and the intrauterine device.
Condoms are the best form of protection against sexually transmitted infections and HIV/AIDS.
What does this mean to me?
According to Melissa Dear, if the new male contraceptive became reality, it would extend the contraceptive choice for couples and, in particular, for men. "We know from calls to our helpline that men often want to share the contraception, but their options are very limited at the moment. The current main options for men are condoms or vasectomy, but this new development would offer a fairly reversible method, which they can try themselves."
She added that the format tested - an implant plus regular injections - is probably only for research purposes. "We imagine they're keeping the two drugs separate (progestin and testosterone) so they can adjust the dosage when they need to. We would imagine that, eventually, when it comes onto the market it will be in a single delivery system, possibly either a tablet or an implant. It's probably not very practical or a very commercial proposition to expect people to have regular injections."
Tony Kerridge, from MSI, stressed that it's unlikely a male contraceptive of this sort would be suitable for single people. He added, "The other thing regarding single people that needs to be emphasised and re-emphasised is that this method wouldn't offer protection against sexually transmitted infections and HIV/AIDS, so the message from MSI is always, always use a condom."
He also made pointed out that a male contraceptive could be crucial for older women at particular risk from side-effects from the oral contraceptive. "For women, when they're over 35, overweight and smokers it can be very risky for them to continue on hormonal forms of contraception, which happen to be the most effective form," he explained.
"So, I think if it's proven over time that this method that's being developed is without any side-effects or risks to men, then somebody who's responsible and caring as a partner won't want their partner to continue putting themselves at risk, and would be willing to step up and take on the contraceptive responsibility and burden within the relationship," he said.
Current forms of contraception available for women include the pill, implants, diaphragms, caps, the intra-uterine contraceptive device (IUCD) and the contraceptive patch.
Summary
Although it's still a long way from being commercially available, the research has provided an important basis for future trials, as well as giving hope to those who yearn for additional methods of contraception. For now, however, it's a case of waiting to see how the research progresses.