Work on RISUG, the vas-based injectable contraceptive that lasts ten years or more, is moving forward slowly but surely. All four study sites now have their paperwork done. The manufacturer is working with a collaborating company on the sterile packaging. Officials hope to conduct a two-day training workshop next month so the sites can get started as soon as the packaging is done.
A representative from India’s drug controller office was part of the team that visited the RISUG manufacturer, and the manufacturing procedures have been okayed. However, it seems that the manufacturer followed WHO manufacturing standards, not International Conference on Harmonization (ICH) standards, which will slow eventual introduction in areas such as the U.S. and Europe that now require ICH standards. This will make future collaboration even more important.
There’s good news, though: The follow-up study of the men who got RISUG in 2001-2002 is moving ahead steadily. The follow-up team has so far contacted about 25 of the 140 men, and several of the men have been into the clinic for tests already. While there are anecdotal reports of RISUG working safely and effectively for up to 13 years, the results of this study will give us the first published data on long-term human use of RISUG, in this case 5 years.
The primary developer of RISUG has just released a report about how RISUG makes sperm unable to swim and fertilize an egg. The researcher used high-power microscopes to examine sperm from men treated with RISUG. Key points: As early as 3 hours after RISUG injection, the outer membrane of passing sperm was damaged, but the sperm’s nucleus and DNA were unaffected. This means sperm become infertile well before their genetic material can be damaged – more data indicating the safety of RISUG in relation to birth defects. The study also helps explain why RISUG takes effect so much more quickly than vasectomy.
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There are lots of male hormonal contraceptive (MHC) formulations being tested around the world – what do the men who test these contraceptives think of them? Are they easy to use? Are the side effects they experience worth the trade off? What inspired them to volunteer for the trial? The World Health Organization (WHO) talked to men in two MHC studies – one in China and one in Italy – and asked them just such questions. The WHO has summarized their results in a poster:
-- Nearly all (92%) the men in the Italian study agreed that men and women should share responsibility for contraception.
-- Chinese men stated that sharing responsibility for family planning was the most important reason for their participation in the trial.
-- Of the men in China, more than half of them were satisfied with the method (62%), but 38% thought it was inconvenient. The main thing they found inconvenient was not pain or side effects; it was having to go into the clinic every month for an injection.
-- The Italian guys thought the shots themselves were the biggest disadvantage, and similar to their Chinese peers, fewer than 10% of them found side effects a major problem. Of the 44 men who completed the study, 61% thought the method was excellent or good. About a third thought it was okay, or okay if there were no alternative.
The WHO concluded in their poster that the method has potential, but getting away from frequent injections would be a big plus.
What do you think about hormonal contraceptives? If you haven’t already, let policymakers know in the MaleContraceptives.org survey.
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For those of you who have already participated in the MaleContraceptives.org survey, here is the result!
Last month we told you about the first issue of the International Male Contraception Coalition’s quarterly report for policymakers, summarizing the quarter’s most intriguing clinical findings and best policy guidance. The report also presents the first analysis of market survey data collected since September of 2006, showing that men and women around the world are ready for new male contraceptives. Now it’s available for download.
The Quarterly is under a Creative Commons Attribution license, meaning it can be freely reproduced and excerpted provided it is attributed to the IMCC.
Read the report:
Male Contraception Quarterly, Number 1
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Word’s getting out. The nonprofit Male Contraception Information Project and Male Contraception Coalition have had a booth at the medical industry’s Contraceptive Technology conference for several years now, but this year the 600 attendees of the San Francisco conference learned about emerging male contraceptives on the main stage. A well-respected presenter gave a talk called “Future Contraception: What’s in the pipeline?” and devoted half of it to the latest information on RISUG, male hormonal contraception, the Intra Vas Device, and Adjudin research. She will deliver the same presentation to an equal number of attendees at the Washington, DC, Contraceptive Technology conference at the end of the month.
The nurses and doctors we spoke to at the conference were excited to learn how many male contraceptive products are in advanced clinical trials, and excited to have other options for the men they work with. They also had fun checking out our sample IVD. It’s all part of keeping up the awareness that there are promising methods in need of further development support.
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A lively story on MSN.com includes quotes from MCIP and the IMCC, and brief coverage of RISUG, hormonal approaches, and the “dry orgasm pill” research.
What you think of the article will depend on whether you see the glass as half empty or half full. For example, 55% of men saying they’re interested in using a new contraceptive is more impressive when you consider that the statistic includes men in predominantly Muslim Indonesia. And we found it particularly striking that a new MSN-Zogby poll showed 36% of American adults said their “current method is fine.” Can you imagine if only 36% of people were happy with their cell phone or their brand of breakfast cereal? Every company would be piling into the market hoping to make a fortune!
A Guy Thing? Male birth control products are getting closer to market – really – but the question remains if men will use them
By Maggie Koerth-Baker, MSN.com, March 16
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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.
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