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It’s 2008 already; how did the various male contraceptive methods being studied fare during 2007? Here's a quick summary, with a focus on the methods already in clinical trials:
Male Hormonal Contraceptives
Multiple clinical trials on various formulations have now shown they work well and fertility comes back afterwards. Two startup companies are making progress on testosterone that can be taken as a pill instead of shots or implants. However, researchers are still trying to figure out why it doesn’t work well enough in about 1 in 10 men. Most research is happening at university labs, as the last big pharma companies quit hormonal male contraceptive development work in 2007.
Intra Vas Device, US design
Researchers are more than halfway through the Phase I study of 82 men who received the implants last year. (The plugs block sperm like vasectomy but are hoped to be more reversible.) Early results show time to infertility similar to vasectomy by traditional techniques (as opposed to the new gold-standard vasectomy technique, fascial interposition, which makes sperm counts drop faster). The study has pointed out several simple changes which will make insertion much easier. The company is gathering investors, and will ask the FDA to approve a larger study at 15-20 North American sites as soon as enough data are in, giving men in many more regions an opportunity to participate. The next study will begin to address the question everyone is asking: how well would fertility come back if the IVD is taken out several years down the road?
Intra Vas Device, Chinese filter-core design
Press reports, yet to be confirmed, tell of testing in over 1,600 men in China with 100% success. The Male Contraception Coalition will be reporting more information on this method in the next few months, including newly translated clinical trial publications.
Testicular Ultrasound
Investigators are continuing to refine their equipment and techniques in small pilot studies. Once lab results match up more closely with those reported in the original studies, they’ll begin the planned bigger study in rats. If ultrasound works for this respected team of researchers, it would be a big boost for this method. Ten minutes of ultrasound on the testes provided about 6 months of contraception in studies in the 1970’s and 1980’s in rats, rabbits, monkeys.
Vitamin A Receptor Antagonists
Tests in mice found about 14 weeks of contraception from 7 days of treatment with this nonhormonal oral contraceptive. Columbia University researchers are looking for funding to take work to the next level – testing in monkeys. Monkey studies get expensive quickly; think seven figures. In the meantime, the researchers are stretching the length of treatment to see if fertility still comes back. The current experiments will test the effects of repeated doses over 3 months. One big advantage to this contraceptive: Significant safety work has already been done in humans, because the drug was originally developed for another use.
RISUG
The Phase III clinical trial in India continues enrollment.
No news…
Tripterygium wilfordii derivatives, wet heat, artificial cryptorchidism, Dr. Joseph Hall’s enzyme inhibitor approach, an Eppin immunocontraceptive, high-intensity focused ultrasound (HIFU) for permanent vas occlusion, and gossypol as a nonsurgical but possibly permanent method (a vasectomy alternative).
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Male contraception research has made great strides in the past year, with overwhelming evidence of public demand (that’s you!), several new studies started, and the September "Future of Male Contraception" conference cementing the new energy and enthusiasm. Researchers and policymakers really understand now that men and women want new methods.
Where would we like to be a year from now? Here is Elaine Lissner of MCIP’s wish list, what we'd like to be reporting to you at the end of 2008:
- Studies on the 5 unexplored Tripterygium wilfordii extracts started. This readily-available Chinese herb is used to treat autoimmune diseases (such as lupus and arthritis) and is known to have contraceptive effect; researchers hope that one of its extracts will have contraceptive effect but not too much immune action. One of its extracts did not work out, but researchers should get funding to test the other five. A study in the Chinese Journal of Andrology said the pill form of this herb (glycosides of T. wilfordii) also has contraceptive effect, and a small study in men should check this out.
- Advancement of Shepherd Medical Company’s Intra Vas Device clinical trials to Phase II, meaning a larger study that men all over North America could participate in.
- Funding to test Columbia University researchers’ oral method in monkeys.
- FDA input on what the next step should be for testicular ultrasound — possibly a clinical trial with men planning vasectomy — upon successful results from the current study.
- Foundations funding the first India-US collaboration on RISUG: large-scale GMP manufacturing followed by a rabbit study. In addition, release by the Indian Council for Medical Research of results of the long-term follow-up study (based on interviews and exams of the several hundred men who have had RISUG 5 to 7 years), providing the first published data on RISUG's long-term effects in humans.
- Planning already underway for the next "Future of Male Contraception" conference, with organizers making sure there’s travel money for researchers from India and China to come share their work.
Kirsten Thompson, director of the International Male Contraception Coalition, adds the following items:
- Continued development of testosterone formulations that can be taken in pill form (rather than as shots), and a better understanding of why hormonal contraception doesn’t work in some men.
- Grantmakers coordinating and organizing their giving, based on a clear set of priorities.
- A survey of North American doctors and family planning providers to understand their attitudes toward new male contraceptives.
These are just some of the advances we hope to be able to report at the end of 2008. By continuing to spread the word about new male contraceptive leads and by filling out our survey if you haven’t yet, you can help leverage funding for this work.
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Male contraception hits the humor column! "Unconfirmed Sources" presents a parody story on "Plan D," the supposed experimental male contraceptive mistakenly released by the manufacturer "Barred Pharmaceuticals." Women who gave it to their partners reported "an overall diminished interest in sex from their partners with an increase in their emotional attention span" and "no real adverse side effects such as sedation, and in fact, their partners appear to be more energetic and involved with completing household chores." Of course the real male contraceptives in development aim to work without changing hormone levels, leaving men and women to divide up household chores without pharmaceutical intervention...
Experimental Plan D Released as Over the Counter by Mistake [parody]
Unconfirmed Sources, 8 January
A funny but thought-provoking column, with comments, by an Australian guy on how he talked himself into a vasectomy after hearing lots of myths and having one false start. "The operation was as smooth as a gravy sandwich. As the hot laser deftly did its work, I found myself humming Jerry Lee Lewis's immortal lines: "Goodness, gracious, great balls of fire!"
Taming of the cue
The Sunday Times (Perth), 11 January
Dr. R.S. Sharma, Deputy Director General of the Indian Council of Medical Research, gives a brief update on the RISUG clinical trials process, mentioning that the current study has been exlarged to 10 centers in India .
Injectable male contraceptive trial enters phase III
Daily News and Analysis India, 25 January
Researchers in Australia are trying to design a radio-controlled vas device. You’ll likely be seeing a lot of this in the press, even though it is very preliminary work. Don’t hold your breath on this one; methods like the IVD are likely to be available much sooner!
Radio-controlled sperm 'tap' turns off vasectomies
New Scientist, 28 January
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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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