In early September more than 500 doctors, nurses and clinicians at the Association for Reproductive Health Professionals conference learned about the three types of male contraceptives in clinical trials: IVDs, RISUG, and male hormonal contraceptives. MCIP and the Male Contraception Coalition were in attendance to ensure that ARHP members have all the latest information on male contraceptives. Welcome to those of you who signed up for this newsletter at our booth!
Would you like to be prepared when you get questions about new options for men? You can refer clients to the lay-oriented information at MaleContraceptives.org. A MaleContraceptives.org flyer in your office or exam room will help them remember.
Schering and Organon teamed up in 2002 to study a male hormonal contraceptive in Europe. They used a yearly progestin implant – Organon’s Implanon – to suppress sperm production, and a quarterly testosterone injection – Schering’s Nebido – to maintain androgen levels. They tested this new combination for effectiveness and acceptability. Their results haven’t been published yet, but their latest announcement states that while the method works well, its delivery route is not well accepted. (A 2005 study sponsored by Schering showed that the majority of men surveyed would prefer a pill over an injection or implant.) Since combining their products did not result in an appealing contraceptive, leaders of both companies have announced that they will work towards a male hormonal contraceptive separately.
What will this mean for hormonal male contraception? If the companies’ leaders remain committed, they may come up with a more acceptable product. In any case, researchers at other organizations are following promising male hormonal contraceptive leads. Researchers are still a long way from a pill, but at the University of Washington, a quarterly injection of progestin was successfully combined with daily testosterone gel. The World Health Organization is slated to begin trials of combined testosterone and progestin injections next year.
Learn more:
Read the joint Schering/Organon press release.
Read the results of the UW testosterone gel trial.
Read about the planned WHO combined injection trial.
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The Intra Vas Device (IVD) clinical trial will soon be accessible to more men! The IVD is a tiny set of silicone plugs which can be used as a “kinder, gentler” alternative to vasectomy cauterization. Many men debating whether or not to have a vasectomy find the idea of a plug more appealing. Because there has been lots of interest, the developers are now planning on study sites in Louisiana and Florida, plus a second site in Minnesota, for four total.
Interested patients can contact the clinical study manager, Janelle Antil, at IVDinfo@shepherdmedical.com.
You can learn more about the goals of the trial at the National Institutes' Clinical Trial register.
You can read about the Intra Vas Device and how it works at MaleContraceptives.org.
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RISUG is the promising long-term, nonhormonal male contraceptive which has proven reversible in animals and appears effective in men for longer than a decade. On the road to potential commercial development, RISUG is now facing a decisive challenge. MCIP attended meetings in New Delhi, India, last month and learned firsthand about that challenge. How the challenge is met will determine whether RISUG will ever be available to men outside of India.
A little history: Last spring, RISUG researchers got approval to re-start the final phase of clinical studies and enroll hundreds of additional men throughout India. There was only one problem: they didn’t have the RISUG material they needed due to manufacturing delays!
A U.S. nonprofit offered to work with the RISUG team and the Indian government to evaluate the situation at the current manufacturing partner and find other partners if necessary. However, the nonprofit didn’t get the meeting it needed to show Indian government buy-in. And as long as the government, the researcher, and the manufacturing partner have a nondisclosure agreement, the inventor can’t reveal enough about the material to get meaningful information on who else could manufacture it.
How will this be resolved? It is still not clear. Right now the inventor is giving it one more try with the current manufacturer, hoping that if everybody involved puts in twice as much effort as before, they can get top-quality material made quickly.
For men the world over, the stakes are high. Decisions over the next few months will make or break RISUG. If the upcoming clinical trial uses material which meets the most strictly-enforced international standards (“ICH GMP”), the results of the clinical trial will be accepted by regulatory agencies all over the world. However, method developers could save a few months by having the material certified to the less strictly-enforced World Health Organization standards (“WHO GMP”).
So why not use the faster WHO GMP certification, especially when men are impatiently awaiting the method and there have been so many delays already? For one major reason: The results of that clinical trial will then be nearly useless for approvals outside India.
Phase III clinical trials are hugely expensive and take years to complete. Cutting any corners on record-keeping would be a sign to funders and governments that the supporters of the method do not believe it has international potential. No funder would be willing to step forward to pay for a repeat clinical trial if it was perceived that the first one was made useless outside India for the sake of saving a few months and a few hundred thousand dollars.
Furthermore, India is becoming more international every year. It is entirely possible that India could adopt the international ICH GMP standards during the next few years, leaving the clinical trial vulnerable to being stopped at any time during its five year span.
Those waiting for a long-acting, reversible nonhormonal method should hope that the developers of this promising contraceptive receive the political and public support they need to make the material with documentation that will stand the test of time.
Take action:
Send MCIP an e-mail to forward to the method developer and regulators. Let them know how excited your patients and colleagues would be to have an affordable, nearly side-effect-free long-term method, any experiences or situations which illustrate the need for new contraceptive options, and how important it is to you that the results of the upcoming trial be acceptable to regulators all over the world in order to facilitate the eventual application process in your country.
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Male contraception research is in the news, once again! The Australian Newsweek profiled a researcher looking for new potential targets for male contraceptives. The researcher explains in plain language how investigators hunt for new drug targets. Includes a discussion of Australian men’s and women’s attitudes toward male contraception: “The inconceivable truth about a male pill”, September 20, 2006.
News of male contraceptive research reaches the public on yet another continent: Kenya’s largest newspaper, the Daily Nation, featured an opinion piece mentioning research on the IVD and suspensories: “Our men, too, should go for the pill”, September 9, 2006. (Requires registration.)
Hitting the stands in just a few weeks, the November Jane magazine will feature a piece on male contraception research in its “big, fat birth control story.” Jane’s teen and 20-something readers will learn what’s in the pipeline and when they might ever see it.
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One of the biggest hurdles to the development of new contraceptives for men is the belief that there is no market for such products. MaleContraceptives.org has launched a new survey to help dispel that myth. Let your patients and colleagues know that they can participate in this survey to help prove the demand for new contraceptives for men.
This survey isn’t just for men – the participation of both men and women is important. It takes fewer than 5 minutes to complete.
The survey results will be aggregated quarterly and sent to key policymakers and pharmaceutical industry leaders who have the power to speed male contraceptive research and development. The reports will be publicly available.
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Want to stay on top of upcoming events in the andrology, endocrinology, and male contraceptive research community? The researcher and policymaker version of this newsletter contains an extensive events calendar, with conference, seminar and CME listings. The researcher version of the newsletter is in the Male Contraception Update Archive. The researcher newsletter also features summaries of the latest peer-reviewed publications in the field, and highlights from conference abstracts and posters.
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Editors
Elaine Lissner, Director of the Male Contraception Information Project (MCIP)
Email: info@NewMaleContraception.org
MCIP is entirely nonprofit and works in three areas: raising public awareness of promising nonhormonal male contraceptives, advocating increased and expedited government research, and serving as a resource for journalists who wish to write about the subject.
Kirsten Thompson, Director of the Male Contraception Coalition (MCC)
Email: info@MaleContraceptives.org
The Coalition’s objectives are to speed the development of new male contraceptives through increased legislative and institutional support, to raise funds for applied male contraception research and development, and to educate the public about the work of the research community.
