Great news on the IVD! There has been so much interest in the clinical trial that the developers have asked the FDA for permission to expand the trial to three more sites! Many men receiving this newsletter have written to Shepherd Medical expressing interest and can take credit for being part of making this expansion happen.
Now the trial will be accessible to more men. Along with St. Paul, Minnesota, the method developers need to choose three more sites out of five choices:
- Los Angeles, California area
- Shreveport, Louisiana
- Tampa, Florida
- St. Cloud, Minnesota
- North Carolina
If you have patients or colleagues considering a vasectomy and eager to try a “kinder, gentler” alternative, have them let Shepherd Medical know right away if they live near one of those sites and want to participate. The level of interest Shepherd receives will factor into the decision on which sites to choose.
On Monday the St. Paul, Minneapolis site will have its IRB meeting, so if all goes well, that site will be able to start within two weeks. Then Shepherd Medical will get a “yea or nay” on the additional sites from the FDA within the next 20 days (they have already gotten positive feedback, so it’s looking good).
Shepherd Medical's clinical study manager, Janelle Antil, can be contacted 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.
Columnist Georgie Binks brings a mother’s perspective to her piece for CBC News. What do young men need to know about contraception as they go out into the world?
Binks points out that “pregnancy should be a big worry for males these days, because the law has made them financially responsible for their children financially, but the condom or a vasectomy are still the only two birth control options available to men. Once a woman becomes pregnant, it's her decision whether or not to continue the pregnancy.” She then discusses new methods that could give men more options, with a quote from MCIP’s director and a link to MaleContraceptives.org.
Check out this interesting opinion piece at CBC News online.
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Ever wonder what men see in Playboy these days? Here’s your chance to do some sociological research!
Look beyond the nearly-identical, airbrushed blondes with attributes not found in nature. Ignore the part about Hugh Hefner ’s barely legal girlfriends, and turn right to the part where the advice columnist answers a real-life question about heat methods of contraception (the use of raised testicular temperatures to produce temporary infertility).
Here’s the situation: A man saw a piece about heat methods of contraception on the Discovery Health Channel and writes in wanting to know if he can make a fortune selling a warming pouch that men can use to make the heat methods more practical. Can he change the world – and his bank balance – by popularizing a battery-powered pouch?
The
Playboy Advisor says he’s not the first to have this idea: “We’re sorry to disappoint you, but you’re 80 years behind the times. Scientists have been studying the effects of heat on sperm since at least the 1920s…” The columnist manages to explain quite a bit about heat methods in a short space, mention other research, and even get in a mention of MCIP’s website.
Playboy is one of the few media outlets which still has a dedicated fact-checking staff, and there’s not a single error in the piece. They deserve credit for alerting men to this research. Add in articles on voting district gerrymandering and Congress’ abdication of the responsibility to maintain checks and balances in government, plus an interview with FEMA chief Michael Brown in which he tells his side of the story, and you can honestly tell the cashier, “I’m buying it for the articles!”
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Ever wonder what it would be like to use hormonal male contraception? Britain’s The Independent interviewed a study volunteer to find out. The interview is part of a piece on the ongoing development of male hormonal contraception. The article also digs into public attitudes and the role of pharmaceutical companies.
Read the full article in
The Independent news online.
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The clinical trials page at MaleContraceptives.org now has new contact information for two upcoming trials whose enrollment processes will start over the coming months. One is the IVD trial described above in this newsletter; the other is an international study of hormonal male contraception sponsored by the World Health Organization. Please pass this information along to anyone who would be interested.
The World Health Organization will coordinate a trial of the effectiveness of a male hormonal contraceptive injection administered every 2 months. This trial will take place in 10 clinical trial centers around the globe: Italy, Indonesia, the US, the UK, Australia, Germany, India, China, and possibly Finland. The purpose of this study is to “establish the contraceptive efficacy of a combined androgen + progestogen regimen for male fertility regulation.” Volunteers will receive combined injections of testosterone undecanoate and the progestin NETE for up to one year.
Read more about this planned trial in the World Health Organization's Reproductive Health clinical trial register.
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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.
