LONDON, Jul 18 (Reuters Health) - The Dutch pharmaceutical company Organon
is to begin full-scale clinical trials of a potential male contraceptive
following successful study results reported Monday by researchers in Scotland.
A spokeswoman in Holland told Reuters Health that the Scottish team's
results were "very encouraging" as they showed the contraceptive can completely
inhibit sperm production. The company expects to begin a phase ll trial at the
end of 2000 or early 2001.
The news follows an independent study at the center for reproductive biology
in Edinburgh in which all 60 men given one of two doses of a combination of the
female hormone progestogen desorgestrel and a testosterone implant attained zero
sperm count.
"There was nothing that would cause men any harm," clinical research fellow
Dr. David Kinniburgh told Reuters Health. "The only side effects were similar to
those sometimes seen with women taking oral contraceptives: The men put on a bit
of weight."
He explained that while many earlier studies successfully suppressed sperm
in just two-thirds of men, "this is the first large study to work 100 percent.
Not only is it the largest study, it is also the first study to show (the drug)
works in two ethnic groups."
Kinniburgh said the next stage would seek to refine the formulation so that
the testosterone can be administered by injection instead of via implants given
every three months. Trials would also be performed to learn if the new male
contraceptive works in the absence of other forms of birth control.
Professor David Baird will present results from the Scottish study at a
conference in Washington, DC, later this year.
