Shepherd Medical Company is preparing for enrollment in their 90-man FDA-approved study of this long-term contraceptive. The Minneapolis/St. Paul site is going throught its institutional review board process this month. However, the Seattle site has fallen through! The researchers are working to set up a new site, as they've had lots of inquiries from men on the west coast. So they're hunting for a great vasectomy doctor in Seattle, Portland, San Francisco, or Los Angeles who has the skills and setup to be a clinical trial investigator. They have a couple leads, and we hope to hear good news soon.
Meanwhile, men in the Great Lakes area who are interested in the IVD as an alternative to vasectomy may want to reserve their spot in the Minneapolis study sooner rather than later, as there’s been a fair amount of interest. The IVD is a "kinder, gentler" vasectomy with a possibility of a greater chance of reversibility, since the plugs can be taken out more easily than a vas deferens can be stitched back together.
Read more about how the IVD works and what's known (and not known) about reversal.
If you are an interested no-scalpel vasectomy specialist or you have patients interested in trying the IVD in this trial, contact Janelle Antil, Clinical Affairs Manager for the Shepherd Medical Company.
Take one part styrene and one part maleic anhydride. Purify them multiple times and ways, then add ethyl acetate in a nitrogen atmosphere. Fuse it all together. Now do more purification, filtering, and drying steps, all the while keeping mountains of paperwork about compliance with Good Manufacturing Practices (GMP) standards and paying a staff of inspectors to watch over everything. Now mix the powder with the purest DMSO and figure out how to get the resulting extremely thick gel into thousands of small-bore syringes while maintaining sterile conditions.
Turns out making RISUG isn't so easy! RISUG developers got approval this spring to re-open their clinical study and enroll hundreds of additional men, but they're still struggling to get the RISUG material mass-produced – which requires a different approach and more logistical coordination than making laboratory quantities.
There's hope, though. Recognizing the potential importance of a long-term contraceptive such as RISUG, a respected NGO which specializes in technology advancement has offered to partner with the Indian government in moving the manufacturing forward.
The goal would be to plan a strategy that will minimize such delays in the future. Stay tuned.
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One of the biggest obstacles in creating a hormonal male contraceptive is the limited number of effective testosterone formulations. Testosterone comes in patches, gels, implants and injections – but not as a pill.
Researchers have improved injected testosterone formulations over the years – they now deliver steady doses of testosterone over 3 months. At a recent conference, one of the most respected research groups in this field announced results from over 8 years of working with a long-acting, injectable testosterone, testosterone undecanoate. They reported that the men in their study had healthy prostates and experienced an incease in bone density. Read their abstract online.
In addition to improving injectable formulations, researchers continue to hunt for an oral form of testosterone.
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After increasing coverage online, male contraceptive research is starting to show up in the print media as well. This month doctors throughout Canada got to read about male contraceptive advances as front page news in the National Review of Medicine, a bi-weekly newspaper for Canadian physicians. The story covered RISUG, the IVD, and even one of the neglected heat methods, along with the pros and cons of hormonal approaches. You can read it online.
Coming up soon: keep an eye out for a story in Men's Health magazine, and some thoughts on male contraceptive research from the advice columnist in Playboy!
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A summary of selected new publications related to andrology and male contraceptive research, categorized by contraceptive approach. For a more complete list including preclinical research, see the research community newsletter in the Male Contraception Update archives.
Endocrine approaches
“Current combinations of T and progestogens completely suppress spermatogenesis without severe side effects in 80-90% of men, with significant suppression in the remainder of individuals.”
“Male hormonal contraceptives.”
Amory JK .
Minerva Ginecol . 2006 Jun;58(3):215-26.
PMID: 16783293
Heat-based approaches
“Intermittent scrotal insulation affected not only the motility of the freshly collected sperm, but also their ability to withstand the additional stress of storage. The additional data on motility characteristics obtained by CASA appeared to be no more sensitive an indicator than the [manually counted] percentage of motile cells…”
“Ram sperm motility after intermittent scrotal insulation evaluated by manual and computer-assisted methods.”
Arman C, Quintana Casares PI, Sanchez-Partida LG, Setchell BP.
Asian J Androl. 2006 Jul;8(4):411-8.
PMID: 16763716
Supporting research
A study of a non-clinical population which used CASA to show “that as men age, they produce fewer motile sperm, which are able to travel less along a linear path, thus covering less forward distance per unit time.”
“Quantitative effects of male age on sperm motion.”
Sloter E, Schmid TE, Marchetti F, Eskenazi B, Nath J, Wyrobek AJ.
Hum Reprod. 2006 Jun 22; [Epub ahead of print]
PMID: 16793993
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Upcoming events in the andrology, infertility, endocrinology, contraceptive and family planning service provision communities. Planning an event? Let us know about it!
July 29 - Aug 1 |
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September 7-10 |
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October 10-12 |
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October 21-25 |
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October 26-30 |
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November 5-8 |
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November 12-16 |
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November 16-18 |
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December 3-8 |
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December 4-7 |
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December 8-10 |
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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.
