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 testosterone levels. They tested this new combination for effectiveness and acceptability. Their results haven’t been published yet, but this announcement states that while the method works well, men were less than thrilled about its delivery method. (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 didn’t 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.
Take action:
• Contact Schering and Organon and let them know you want them to bring a male hormonal contraceptive product to market. Send your message to Schering’s pharma communications specialist, Astrid Kranz (astrid.kranz@schering.de) and Organon’s public relations officer, Monique Mols (monique.mols@organon.com).
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.
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 be available to men outside of India in your lifetime.
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 Indi . There was only one problem: they didn’t have the RISUG material they needed!
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 secrecy 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’s still not clear. Right now the inventor is giving it one more try with the current manufacturer, hoping that if everybody involved puts twice as much effort as before into the project, they can pull it off and 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 (called “ICH GMP”), the results of the clinical trial will be accepted by regulatory agencies all over the world. However, it’s tempting to 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. Nobody would be willing to step forward to fund a repeat clinical trial if it was perceived that the first one was made useless outside India just to save a few months.
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. That could mean years of effort down the drain!
Supporters of RISUG should hope that the developers of this promising contraceptive receive the political and public support they need to dot every “i” and cross every “t” – to make the material with documentation that will stand the test of time.
Take action:
• Send MCIP an email to forward to the inventor and regulators. Let them know how excited you are about this Indian invention, that you’re hoping to be in a RISUG clinical trial as soon as it comes to your country, and how important it is to you that the results of the upcoming trial be acceptable to regulators all over the world.
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The Intra Vas Device (IVD) trial may be coming to a city nearer you! The IVD is a tiny set of silicone plugs which can be used instead of cutting the vas deferens (vasectomy). Because there’s 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.
Learn more:
• Contact the clinical study manager, Janelle Antil (IVDinfo@shepherdmedical.com).
• Read a description of the IVD clinical trial design.
• Read about the Intra Vas Device and how it works.
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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 readers will learn what’s in the pipeline and when they might ever see it.
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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 MaleContraceptives.org were in attendance to ensure that doctors whose clients ask about new male contraceptives have all the latest information. These medical practitioners will take home the message that new male contraceptives can be a reality if we all continue to get the word out and push for them.
However, not every doctor makes it to the annual conference. You can help spread the word: Do you think your doc might not know about the resources at MaleContraceptives.org? Before your next visit, print out a MaleContraceptives.org flyer and see if he or she will put it up in the office.
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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. 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’s quick – fewer than 5 minutes to complete it. You can also personalize your interest in new male contraceptives by telling your story.
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.
A special thanks to all of you who helped fine-tune the survey!
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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 Contraceptive 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.
