The primary developer of RISUG (the vas-based injectable contraceptive that lasts ten years or more) has just published a study 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. Quick onset of action gives RISUG an advantage over vasectomy, because it reduces the number of early failures due to noncompliance with backup contraception.
RISUG clinical trials are 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 in April 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 Male Contraception Coalition will have a booth in the exhibitor hall at the Contraceptive Technology conference in Washington DC from March 28-31. We’ll have information on the emerging male contraceptives in clinical trials, vasectomy best practices, and tips on working with men in clinical settings.
The nonprofit Male Contraception Information Project and Male Contraception Coalition have had a booth at the Contraceptive Technology conference for several years now, but this year the 600 attendees of the March 7-10 San Francisco conference learned about emerging male contraceptives on the main stage, too. Sharon Schnare presented “Future Contraception: What’s in the pipeline?” and devoted half of her talk to the latest information on RISUG, male hormonal contraception, the Intra Vas Device, and Adjudin research. She will deliver the same presentation at the Washington, DC, Contraceptive Technology conference – don’t miss it.
The providers we spoke to at the conference were excited to learn how many male contraceptive products are in advanced clinical trials, and pleased to be able to pick up information so they’ll know what to say when they get questions from patients. 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. If you’ll be at the DC conference, stop by and say hello!
Return to the top
“The mission of the Family Planning Male Training Center (FPMTC) is to ensure that personnel working in Title X family planning service projects will receive on a continuing basis the knowledge, skills and abilities necessary to effectively provide family planning and reproductive health information, education and clinical services targeting males.” The FPMTC coordinates regular training events and accepts requests for clinical updates. They also keep up to date an electronic library of male reproductive health resources, an educational resource inventory of training curricula and methods, and a male program registry of family planning projects with male components. “The FPMTC works collaboratively with the ten Office of Family Panning (OFP) Regional Training Centers and other community-based and academic organizations to provide training and leadership in promoting male family planning and reproductive health issues.”
If your office already sees male clients, you may find their Guidelines for Male Sexual & Reproductive Health Services helpful. The guidelines “are intended to be comprehensive and to include all services that could be provided in the family planning clinical setting. The document can be used as a helpful resource in the development of clinical services for male clients.”
If your office is just beginning to offer services for men, or is planning to do so in the future, you may find the Center for Health Training’s Blueprint for Male Involvement helpful. The blueprint is designed to be “useful tool in efforts to examine the importance, benefits and challenges of involving young men in family planning and reproductive health. It is designed to examine the process of formulating an outline or plan of action for developing or expanding male involvement initiatives.”
Return to the top
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 men 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.
Do you get questions about the “male Pill” from patients? If they’re impatient for new options, let them know they can make their voice heard by filling out the MaleContraceptives.org survey.
Return to the top
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
Return to the top
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, the article cites a study in which only 55% of men say they would certainly be willing to use a new male contraceptive – but that’s more impressive when you consider that it’s from a 9-country study which included 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 the effectiveness of their flu shot or the reliability of their pap smear? 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
“On December 13, 2006, the National Institutes of Health (NIH) announced the early termination of two randomised controlled trials of male circumcision – in Kenya and Uganda – on the basis of interim evidence that male circumcision provided a protective benefit against HIV infection of 53% among the 2784 Kenyan men and 51% among the 4996 Ugandan men enrolled in the respective studies.”
Male circumcision and HIV/AIDS: challenges and opportunities (Login required)
The Lancet, 24 February
There has been an interesting ongoing discussion of the implications of the male circumcision trial findings on Androlog. If you are not an Androlog subscriber, you can read the “Risk/benefit analysis of circumcision and HIV” thread in the Androlog archives.
Are you a member of the National Association of Nurse Practitioners in Women’s Health? The NPWH’s March edition of the Monthly Cycle included a brief on the MaleContraceptives.org survey: “The International Male Contraception Coalition reports that men and women are ready for male contraceptives. A survey questions both sexes on their current contraception practices and asks them how their practices would change if a male contraceptive became readily available. Thus far, there is strong support for male contraceptives and we urge you to weigh in on the issue by completing their survey. Visit http://www.malecontraceptives.org/ for more information on male contraceptives and to participate in the survey.”
Return to the top
Planning to attend a family planning or andrology-related event that's not listed here? Let us know so we can post it and alert your colleagues to interesting upcoming events.
March 28-31 |
Contraceptive Technology 2007 East Coast conference; Washington, DC, USA |
April 30 - May 2 |
Family Planning Male Training Center’s Annual Male Reproductive Health Conference, “Building Effective Male Family Planning Programs”; Memphis, TN |
May 21-24 |
Family Planning Male Training Center’s 2nd Annual Male Health Training Institute for Title X program administrators and managers; Cincinnati, OH |
May 29 - June 28 |
East-West Center’s 38th Summer Seminar on Population “Communicating with Policymakers about Population and Health” Workshop; Honolulu, HI, USA |
September 26-29 |
Joint meeting of the Association of Reproductive Health Professionals and the Planned Parenthood Federation of America, Reproductive Health 2007; Minneapolis, MN |
September 27-28 |
2nd Future of Male Contraception conference; Seattle, WA, USA |
November 3-7 |
American Public Health Association 2007 Annual Meeting “Politics, Policy & Public Health”; Washington, DC |
Return to the top
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.
|
