Trial on Dysfunctional Uterine Bleeding
Thomas L. Lyons, MD, Conducting Clinical Trial On Dysfunctional Uterine
The Center for Women’s
Care & Reproductive Surgery, headed by laparoscopic pioneer Thomas L.
Lyons, MD, is conducting a placebo controlled FDA clinical trial on a
drug used to control dysfunctional uterine bleeding (DUB).
medication stops the body from breaking down clots in the blood, causing
heavy bleeding to diminish. It has been demonstrated in Europe to
decrease bleeding after being administered during the acute phase of the
Some women enrolled in
the clinical trial will take the drug sporadically through their cycle,
whereas some participants will receive the placebo. It is a randomized
double-blind study, meaning neither the physician nor the patient knows
who is receiving the drug and who is receiving the placebo, to ensure
unbiased clinical results.
Patients who qualify
will receive study drug and related physical exams, electrocardiograms,
eye exams and laboratory tests at no cost. They will also receive
compensation for their time and travel.
numerous clinical trials in the past, and remain very clinically active
because we deal with issues that many pharmacological companies are
testing,” said Dr. Lyons, known for developing the laparoscopic
supracervical hysterectomy, or LSH, a procedure which leaves the woman’s
cervix intact as a keystone support for the anatomy. It has also been
shown in studies to help improve sexual function post-surgery.
Women who experience
heavy menstrual bleeding on two to five days of their cycle, and who
have to alter their normal social and work activities due to heavy
bleeding may be qualified for the study.
Women must be
generally healthy, and between the ages of 18 and 49; have regular
menstrual cycles with heavy bleeding; and not have any other bleeding
Evolution of a World-Class Surgeon
Dr. Lyons began teaching surgeons from around the
world in the late 1980s as he trained others on laparoscopic gallbladder
removal. From there he began exploration and training on tubal
pregnancies, ovarian cysts, fibroids, hysterectomy and endometriosis. At
the present time, even certain cancers can be removed laparoscopically.
In the early 1990s, telesurgery revolutionized the
field and Dr. Lyons began performing procedures in his customary
operating environment while surgeons in Europe or Asia watched, asked
questions and learned remotely.
A video news feature
about Dr. Lyons’ pioneering in the field of gynecologic laparoscopy is
www.ElifeMagazine.net during July 2007.
What Your Doctor Doesn’t Tell You
Although Dr. Lyons has
trained thousands of surgeons on the LSH technique he developed, most
doctors don't perform it.
Some surgeons refuse to
perform laparoscopic procedures on a large uterus, and say it can’t be
done. Left out in that explanation is, “because I can’t do it.” The size
of the uterus is not an issue or a problem for Dr. Lyons.
"It's especially important
that patients choose a surgeon who is experienced in working with lasers
and laparoscopy. LSH requires more skill than open abdominal
hysterectomy. It's easier on the patient, but more challenging for the
surgeon," explained Dr. Lyons.
One of the most important
factors in helping people choose appropriate medical care is a
comprehensive understanding of the reasons for treatment, the risks, and
the potential benefits. This especially applies to hysterectomy. If
hysterectomy has been suggested as an option, women should carefully
weigh the pros and cons, the alternative treatments, the potential
benefits and risks, and the physician's track record.
surgeons will attempt a laparoscopic procedure and feel it necessary to
convert to an open surgery with a long incision during the procedure.
Make sure to ask your surgeon about his or her conversion ratio. Dr.
Lyons' conversion ratio is less than one percent.
information about participation in the trial contact the Center for
Women’s Care & Reproductive Surgery in Atlanta at 770-352-0037 or
Email the Center for Women's Care
Center for Women's Care &
Reproductive Surgery© 2006
1140 Hammond Drive, Suite
Atlanta, Georgia 30328.
Toll Free 1 (888) 545-0400
Metro Atlanta (770) 352-0037
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