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

Main Category: Fertility
Also Included In: Pregnancy / Obstetrics;  Women's Health / Gynecology;  Clinical Trials / Drug Trials
Article Date: 03 Aug 2007 - 0:00 PDT

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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 apainful shot, melting suppository, has no build-up, provides dose-to-dose consistency and is easily self-administered.

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.

About Georgia Reproductive Specialists

Georgia Reproductive Specialists (GRS) applies medical science's most advanced fertility technologies to provide the highest standards of patient- centered, reproductive healthcare.

The staff at GRS, including infertility laboratory pioneer Michael Tucker, Ph.D., is focused on providing individualized, innovative solutions for reproductive challenges and infertility, specializing in in vitro fertilization, intracytoplasmic sperm injection and other assisted reproductive technologies. Fellowship-trained reproductive endocrinologists Dr. Susan C. Conway, Dr. Carolyn Kaplan, and medical director, Dr. Mark Perloe are experts in female and male disorders including polycystic ovary syndrome (PCOS), repeated pregnancy loss, menstrual disorders and azoospermia. GRS has three offices, Atlanta, Alpharetta and Decatur, to conveniently serve patients across Metro Atlanta. For more information about Georgia Reproductive Specialists, visit http://www.ivf.com.

About ENDOMETRIN

ENDOMETRIN 100 mg is an insert administered vaginally two or three times daily, with a disposable matched applicator, starting at egg retrieval and continuing for up to 10 weeks total duration.

ENDOMETRIN administered as a progesterone vaginal insert is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment for infertile women.

Only physicians thoroughly familiar with infertility treatment should prescribe ENDOMETRIN. In clinical trials (n=860), adverse reactions that occurred at a rate greater than or equal to two percent included: uterine spasm (3% to 4%) and vaginal bleeding (3%). Vaginal irritation, itching, burning or discomfort, urticaria, and peripheral edema were reported at an incidence of less than two percent. ENDOMETRIN is expected to have adverse reactions similar to other drugs containing progesterone (breast tenderness, bloating, mood swings, irritability, and drowsiness).

About BRAVELLE and MENOPUR

BRAVELLE (urofollitropin for injection, purified) and MENOPUR (menotropins for injection, USP), like all gonadotropins, are potent substances capable of causing mild to severe adverse reactions, including OHSS (incidence of 6.0% and 3.8%, respectively), with or without pulmonary or vascular complications, in women undergoing therapy for infertility. Like other products for ovarian stimulation, treatment with BRAVELLE and/or MENOPUR may result in multiple gestations. Only physicians thoroughly familiar with infertility treatment, including the risk of multiple births and adverse reactions, should prescribe these medications.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals, part of the Ferring Group, a privately owned, international pharmaceutical company, manufactures and markets the largest family of fertility treatments of any manufacturer in the U.S. The Company markets BRAVELLE, MENOPUR, REPRONEX(R) (menotropins for injection, USP), NOVAREL and ENDOMETRIN in the U.S. to infertility specialists and their patients. Ferring also offers the Q-CAP(TM), the first and only needle-free reconstitution device, for use with its fertility treatments.

Ferring's line of orthopaedic and urology products includes EUFLEXXA(TM), hyaluronic acid for pain from osteoarthritis in the knee. Other products include ACTHREL(R) (corticorelin ovine triflutate for injection) for the differential diagnosis of Cushing's syndrome and DESMOPRESSIN ACETATE in injectable and rhinal tube forms for the treatment of diabetes insipidus and primary nocturnal enuresis.

The Ferring Group specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, gastroenterology, obstetrics/ gynecology and infertility.

Georgia Reproductive Specialists
http://www.ivf.com