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Georgia Reproductive Specialists Participates in Largest-Ever In Vitro Fertilization Clinical Trial in the World

Catherine McDiarmid-Watt | Thursday, August 23, 2007 | 0 comments

Georgia Reproductive Specialists is First to Evaluate New, Patient-Friendly Progesterone Supplement

ATLANTA, Aug. 2 /PRNewswire/ -- Georgia Reproductive Specialists in Atlanta, GA was one of 25 sites nationwide that recently completed the
largest in vitro fertilization (IVF) clinical trial ever in the world. The landmark trial of 1,211 women evaluated ENDOMETRIN(R) (progesterone) Vaginal Insert, 100 mg, a progesterone supplement used in patients undergoing assisted reproductive technology (ART) treatment. Progesterone is necessary to support embryo implantation and early pregnancy.


Based on the trial results, ENDOMETRIN, marketed and manufactured by
Ferring Pharmaceuticals, Inc., was approved by the U.S.
Food and Drug
Administration
(FDA) on June 21, 2007. As the first new, patient-friendly alternative to progesterone supplementation in a decade, ENDOMETRIN was shown to provide unprecedented luteal phase support, measured by ongoing pregnancy and live birth rates, with highly efficient delivery of progesterone.


"We're were honored to have been chosen as a site for this landmark
trial to give women undergoing ART treatment an effective, convenient
alternative to current progesterone treatments,"
said Dr. Perloe reproductive endocrinologist who led the trial at Georgia Reproductive Specialists.
"Our goal is to help ease the patient's journey to parenthood by being able to provide treatments that are designed with the patient in mind. Patients have been dissatisfied with current progesterone supplements, such as progesterone-in-oil intramuscular injections, which can be painful, and suppositories and gels, which can be messy. With ENDOMETRIN, they now have an effective, patient- friendly option."

Clinical trials for ENDOMETRIN were conducted using BRAVELLE(R)
(urofollitropin for injection, purified) and MENOPUR (R) (menotropins for injection, USP) in the initial stimulation phase of treatment. Unlike other infertility treatments, these medications can be mixed in a single syringe for convenient, once-daily administration.


ENDOMETRIN answers an unmet, significant patient need. ENDOMETRIN is not a painful shot, melting suppository, has no build-up, provides dose-to-dose consistency and is easily self-administered. If you would like to learn more about ENDOMETRIN, contact Georgia Reproductive Specialists at 404-843-2229. Georgia Reproductive Specialists can also provide you with information about MENOPUR and

BRAVELLE. Landmark IVF Trial
The safety and efficacy of ENDOMETRIN compared with an active control
were evaluated in a multicenter, randomized, open-label, assessor-blinded
trial in 1,211 women, ages 18-42, undergoing IVF. Efficacy was measured by continuing pregnancy and live birth rates. An analysis was also conducted to evaluate once-daily compared with twice-daily dosing of gonadotropins
during the stimulation phase.


MENOPUR and BRAVELLE were used for the stimulation phase of IVF, with a minimum of one vial of MENOPUR per day. The centers had the option of combining Menopur and Bravelle and administering them as one single daily injection, which was done for approximately two-thirds of the patients (777). On the day of egg retrieval, patients were randomized to ENDOMETRIN 100 mg twice daily, ENDOMETRIN 100 mg three times daily, or an active control ((progesterone vaginal gel (90 mg) QD)).* In the study, 97 percent of patients randomized to participate in the trial received an embryo transfer.

The results showed that ENDOMETRIN was efficacious, with no significant differences in efficacy parameters between treatment arms. Continuing pregnancy rates were 44 percent with ENDOMETRIN TID and 40 percent with ENDOMETRIN BID. Live birth rates were also high: ENDOMETRIN BID 37 percent, ENDOMETRIN TID 40 percent. The groups showed equivalent tolerability, with no significant differences in the incidence of adverse events.

The efficacy of ENDOMETRIN was also evaluated in harder-to-treat
patients - women over age 35 or with elevated basal follicle stimulating
hormone (FSH) or body mass index (BMI). Excellent continuing pregnancy rates were observed across a broad range of patient types with the use of
BRAVELLE, MENOPUR, NOVAREL(R) (chorionic gonadotropin for injection, USP) and ENDOMETRIN.

Full article: http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/08-02-2007/0004638039&EDATE=





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Catherine

About Catherine: I am mom to three grown sons, two grandchildren and two rescue dogs. After years of raising my boys as a single mom, I remarried a wonderful man who had never had a child of his own. Unexpectedly, I found myself pregnant at 49!
Sadly we lost that precious baby at 8 weeks, and decided to try again. Five more losses, turned down for donor egg, foster care and adoption due to my age and losses - we have accepted that there will be no more babies in our house.

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