Male Contraception Update
September 2006 Volume 1, Issue 6


**********In this issue**********

1. Schering and Organon go separate ways on male hormonal
contraceptive development
2. Decision time for RISUG
3. IVD trial expands to three more cities; now in Minnesota,
Louisiana, and Florida
4. Male contraceptive coverage on newsstands the world over!
5. Doctors and nurses learn about emerging male contraceptives
6. Make your voice heard: Prove there's demand by taking our new survey!


****************************


1. Schering and Organon go separate ways on male hormonal
contraceptive development

Schering and Organon teamed up in 2002 to study a male hormonal
contraceptive in Europe. They used a yearly progestin implant –
Organon's Implanon – to suppress sperm production, and a quarterly
testosterone injection – Schering's Nebido – to maintain testosterone
levels. They tested this new combination for effectiveness and
acceptability. Their results haven't been published yet, but this
announcement states that while the method works well, men were less
than thrilled about its delivery method. (A 2005 study sponsored by
Schering showed that the majority of men surveyed would prefer a pill
over an injection or implant.) Since combining their products didn't
result in an appealing contraceptive, leaders of both companies have
announced that they will work towards a male hormonal contraceptive
separately.

What will this mean for hormonal male contraception? If the companies'
leaders remain committed, they may come up with a more acceptable
product. In any case, researchers at other organizations are following
promising male hormonal contraceptive leads. Researchers are still a
long way from a pill, but at the University of Washington, a quarterly
injection of progestin was successfully combined with daily
testosterone gel. The World Health Organization is slated to begin
trials of combined testosterone and progestin injections next year.

***Take action***
Contact Schering and Organon and let them know you want them to bring
a male hormonal contraceptive product to market. Send your message to
Schering's pharma communications specialist, Astrid Kranz
(astrid.kranz@...) and Organon's public relations officer,
Monique Mols (monique.mols@...).

***Learn more***
-- Read the joint Schering/Organon press release
http://www.schering.de/scripts/en/50_media/2006/pi/Q3/060919_Organon.php?n=mep
-- Read the results of the UW testosterone gel trial
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstra\
ctPlus&list_uids=16940442&query_hl=1&itool=pubmed_docsum
-- Read about the planned WHO combined injection trial
http://www.who.int/reproductive-health/rhl/a25165.html


****************************


2. Decision time for RISUG

RISUG is the promising long-term, nonhormonal male contraceptive which
has proven reversible in animals and appears effective in men for
longer than a decade. On the road to potential commercial development,
RISUG is now facing a decisive challenge. MCIP attended meetings in
New Delhi, India, last month and learned firsthand about that
challenge. How the challenge is met will determine whether RISUG will
be available to men outside of India in your lifetime.

A little history: Last spring, RISUG researchers got approval to
re-start the final phase of clinical studies and enroll hundreds of
additional men throughout Indi . There was only one problem: they
didn't have the RISUG material they needed!

A U.S. nonprofit offered to work with the RISUG team and the Indian
government to evaluate the situation at the current manufacturing
partner and find other partners if necessary. However, the nonprofit
didn't get the meeting it needed to show Indian government buy-in. And
as long as the government, the researcher, and the manufacturing
partner have a secrecy agreement, the inventor can't reveal enough
about the material to get meaningful information on who else could
manufacture it.

How will this be resolved? It's still not clear. Right now the
inventor is giving it one more try with the current manufacturer,
hoping that if everybody involved puts twice as much effort as before
into the project, they can pull it off and get top-quality material
made quickly.

For men the world over, the stakes are high. Decisions over the next
few months will make or break RISUG. If the upcoming clinical trial
uses material which meets the most strictly-enforced international
standards (called "ICH GMP"), the results of the clinical trial will
be accepted by regulatory agencies all over the world. However, it's
tempting to save a few months by having the material certified to the
less strictly-enforced World Health Organization standards ("WHO GMP").

So why not use the faster WHO GMP certification, especially when men
are impatiently awaiting the method and there have been so many delays
already? For one major reason: The results of that clinical trial
will then be nearly useless for approvals outside India.

Phase III clinical trials are hugely expensive and take years to
complete. Cutting any corners on record-keeping would be a sign to
funders and governments that the supporters of the method do not
believe it has international potential. Nobody would be willing to
step forward to fund a repeat clinical trial if it was perceived that
the first one was made useless outside India just to save a few months.

Furthermore, India is becoming more international every year. It is
entirely possible that India could adopt the international ICH GMP
standards during the next few years, leaving the clinical trial
vulnerable to being stopped at any time during its five year span.
That could mean years of effort down the drain!

Supporters of RISUG should hope that the developers of this promising
contraceptive receive the political and public support they need to
dot every "i" and cross every "t" – to make the material with
documentation that will stand the test of time.

***Take action***
Send MCIP an email (info@...) to forward to the
inventor and regulators. Let them know how excited you are about this
Indian invention, that you're hoping to be in a RISUG clinical trial
as soon as it comes to your country, and how important it is to you
that the results of the upcoming trial be acceptable to regulators all
over the world.


****************************


3. IVD trial expands to three more cities; now in Minnesota,
Louisiana, and Florida

The Intra Vas Device (IVD) trial may be coming to a city nearer you!
The IVD is a tiny set of silicone plugs which can be used instead of
cutting the vas deferens (vasectomy). Because there's been lots of
interest, the developers are now planning on study sites in Louisiana
and Florida, plus a second site in Minnesota, for four total.

***Learn more***
-- Contact the clinical study manager, Janelle Antil
(IVDinfo@...)
-- Read a description of the IVD clinical trial design
http://www.clinicaltrials.gov/ct/show/NCT00335361?order=2
-- Read about the Intra Vas Device and how it works
http://www.malecontraceptives.org/methods/shug.php


****************************


4. Male contraceptive coverage on newsstands the world over!

Male contraception research is in the news, once again! The Australian
Newsweek profiled a researcher looking for new potential targets for
male contraceptives. The researcher explains in plain language how
investigators hunt for new drug targets. Includes a discussion of
Australian men's and women's attitudes toward male contraception: "The
inconceivable truth about a male pill", September 20, 2006.
http://bulletin.ninemsn.com.au/article.aspx?id=145661

News of male contraceptive research reaches the public on yet another
continent: Kenya's largest newspaper, the Daily Nation, featured an
opinion piece mentioning research on the IVD and suspensories: "Our
men, too, should go for the pill", September 9, 2006. Requires
registration,
http://www.nationmedia.com/dailynation/nmgcontententry.asp?category_id=25&newsid\
=81041

Hitting the stands in just a few weeks, the November Jane magazine
will feature a piece on male contraception research in its "big, fat
birth control story." Jane's readers will learn what's in the pipeline
and when they might ever see it.


****************************


5. Doctors and nurses learn about emerging male contraceptives

In early September more than 500 doctors, nurses and clinicians at the
Association for Reproductive Health Professionals conference learned
about the three types of male contraceptives in clinical trials: IVDs,
RISUG, and male hormonal contraceptives. MCIP and the Male
Contraception Coalition were in attendance to ensure that doctors
whose clients ask about new male contraceptives have all the latest
information. These medical practitioners will take home the message
that new male contraceptives can be a reality if we all continue to
get the word out and push for them.

However, not every doctor makes it to the annual conference. You can
help spread the word: Do you think your doc might not know about the
resources at MaleContraceptives.org? Before your next visit, print out
a MaleContraceptives.org flyer and see if he or she will put it up in
the office.
http://www.malecontraceptives.org/images/MaleContraceptives.org%20flyer.pdf


****************************


6. Make your voice heard: Prove there's demand by taking our new survey!

One of the biggest hurdles to the development of new contraceptives
for men is the belief that there is no market for such products.
MaleContraceptives.org has launched a new survey to help dispel that
myth. Participate in this survey to help prove the demand for new
contraceptives for men: http://www.malecontraceptives.org/new_activism.php

This survey isn't just for men — the participation of both men and
women is important. It's quick – fewer than 5 minutes to complete it.
You can also personalize your interest in new male contraceptives by
telling your story:
http://www.malecontraceptives.org/new_activism.php?actiontype=show_letter

The survey results will be aggregated quarterly and sent to key
policymakers and pharmaceutical industry leaders who have the power to
speed male contraceptive research and development. The reports will be
publicly available.

***A special thanks to all of you who helped fine-tune the survey!***


****************************

***Editors***

Elaine Lissner, Director of the Male Contraception Information Project
(MCIP)
Email: info@...
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 Contraceptive Coalition (MCC)
Email: info@...
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.


****************************