New male contraceptive targets sperm, not hormones
May 5 – Seattle, WA and Minneapolis, MN
Men and women have long been promised a male version of the female contraceptive pill. But the first new male contraceptive to market may not be hormonal at all.
Researchers received Food and Drug Administration approval today for a 90-man study of the Intra Vas Device (IVD), a nonhormonal contraceptive that stops sperm in their tracks. The study, to take place in Seattle, Washington and St. Paul, Minnesota, will bring men one step closer to having their first new contraceptive in more than a century.
"Preliminary studies in animals and men show that this doesn't have the side effects of hormonal methods," said Jim Stice, president of Shepherd Medical Company, a consortium of researchers and entrepreneurs developing the device. "The concept is pretty simple: A set of tiny plugs block sperm as they travel through a tube called the vas deferens. Men don't need to worry that they'll have acne or gain weight or have their sex drive go up or down – all things that can happen when you manipulate hormones."
This will be the second contraceptive study of the IVD in men. In the pilot study, the method was very effective: all 30 men either had no sperm in their semen or had levels too low to cause a pregnancy. Early monkey studies showed reversibility after seven months of use, but reversibility studies in men have thus far only tested same-day insertion and removal.
Elaine Lissner, director of the nonprofit Male Contraception Information Project, is cautiously optimistic. "The Holy Grail of contraception is a long-term, reversible method without any hormonal side effects," she said. "Right now the IVD developers can't guarantee that it's reversible in men like it has been in animals, so they're billing it as a kinder, gentler vasectomy. But if it turns out to be reversible, they're going to have a line out the door."
For pictures, the full story or information on signing up for the study, see the EurekAlert! press release.
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Halfway around the world, another team of researchers is working on a vas deferens-based contraceptive device. It is also – confusingly! – called an Intra Vas Device (IVD). The Chinese version is similar to the IVD being tested by Shepherd Medical, except in two respects. First, it is a single rather than double plug in each vas deferens. Second, the Chinese design features a hollow center filled with medical-grade nylon thread. This mesh acts as a filter, blocking sperm but allowing other fluids through.
In a recently-published 288-man study comparing the Chinese IVD with no-scalpel vasectomy, the filtering action seemed to work: the IVD was an effective contraceptive, and men with IVDs reported fewer complications than those with vasectomy. Researchers attributed the lower incidence of side effects to the filtering action of the IVD, which blocks the sperm but prevents the build-up of pressure behind the plug. The only pregnancies in the study occurred when couples using either method didn’t follow the instruction to use condoms as a backup method for the first three months after the procedure.
Researchers think that reversal will be more successful than with vasectomy, because previous studies have shown that the plug is not as hard on the testes and epididymis as vasectomy is. None of the men from the study have yet asked for reversal, though, so that remains an unknown.
Will the filter become plugged up over time? Will reversibility rates be as good as hoped? Will researchers outside China collaborate on developing this device? No word yet, but stay tuned! And if you're interested in seeing this device studied in the US , write about why to Dr. Duane Alexander, Director of the National Institute of Child Health and Human Development:
Bldg 31, Room 2A32, MSC 2425
31 Center Drive
Bethesda , MD 20892-2425
For further information, read a summary of the researchers’ publication on the National Library of Medicine’s website.
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The work of the male contraceptive research community is covered by all kinds of press sources. Here is a summary of interesting headlines from the last month.
A new article by a group of researchers working to develop a male hormonal contraceptive (MHC) appeared in the April 29 edition of the medical journal Lancet. The study reviewed 30 other studies of different MHC formulations, and found that all the participants regained fertility after stopping treatment. The median time to recovery of fertility was 3½ months. The publication of this article generated major press coverage. Here are some of the better features:
Sperm bounce back after male contraception (28 April, New Scientist)
Effects of any ‘male pill’ should be reversible (28 April, HealthDay.com)
Hormonal birth control for men? (28 April, WebMD syndicated by CBS and FOX)
Men’s and women’s attitudes toward hormonal male contraception have been in the news thanks to both the Lancet article and the 50 th anniversary of the female pill:
Would you take a male pill? (28 April, BBC Radio 1 poll)
Is the male pill good for women? (28 April, the Guardian comment section)
Baby, this is crazy (22 April, the London Times)
For more headlines, check out the In the news section at MaleContraceptives.org.
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Interested in helping spread the word about new male contraceptives? The Male Contraception Information Project (MCIP) could use your help! MCIP works to get news about nonhormonal male contraceptive methods in the media spotlight.
Bloggers
Write about male contraceptives and why you care. You are your own independent media, and we thank you for it!
Volunteers
MCIP would love the help of two types of volunteers: Lexis/Nexis gurus and blog trackers. If you’re interested in volunteering, please contact Elaine.
• Lexis/Nexis gurus. MCIP is building a database of writers who’ve written about new male contraceptives. A guru would look up recent articles about contraception on Lexis/Nexis and pass along the authors' e-mail contact info. MCIP uses the database to send interested writers new press releases and background info.
• Blog trackers. Get your news from blogs rather than NPR? Hooked on de.lic.ous? MCIP needs someone to keep an eye out for blogs featuring new male contraceptives. A tracker would then contact the bloggers to let them know that they can sign up to receive MCIP's press releases directly, making them the first to hear breaking news!
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The MaleContraceptives.org site got some important updates last week.
• RISUG
The Indian Council for Medical Research announced that Phase III trials of RISUG can resume; 4 centers around India have already been approved. This announcement led to renewed interest in RISUG both in India and around the world. The team developing RISUG is now working on manufacturing RISUG to the US Food and Drug Administration's standards and collaborating with a well-respected nonprofit US contraceptive research and development organization which could help guide the US research and approval process.
• Zavesca
In a longer-term study of low-dose Zavesca in mice, researchers found that the drug’s contraceptive effect was reversed faster than the average male hormonal contraceptive. Male mice treated for one year regained their fertility in 9 weeks when treatment stopped.
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Previous issues of the Male Contraception Update are now available online in our Archives. Two nonprofit organizations, the Male Contraception Coalition and the Male Contraception Information Project, work jointly to bring you this newsletter. Have a question about new male contraceptives not answered on our websites MaleContraceptives.org and MCIP.info? Post it to the discussion group.
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Editors
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.
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.
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