Research Compares MENOPUR(R) With RFSH In GnRH Antagonist IVF Cycles

Main Category: Fertility
Also Included In: Endocrinology;  Clinical Trials / Drug Trials;  Pediatrics / Children's Health
Article Date: 21 Oct 2009 - 2:00 PST

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Ferring Pharmaceuticals presented an interim study analysis indicating that MENOPUR® (menotropins for injection, USP) is effective in in vitro fertilization (IVF) cycles using a gonadotropin-releasing hormone (GnRH) antagonist. The results were presented in a poster at the 65th Annual Meeting of the American Society for Reproductive Medicine (ASRM) in Atlanta, October 17-21, 2009.

MENOPUR® vs. rFSH in GnRH Antagonist Cycles Interim Study Analysis

In an interim analysis of a multicenter, randomized, open-label exploratory study of IVF cycles using a GnRH antagonist, patients were randomized prior to stimulation with either MENOPUR® or recombinant follicle stimulating hormone (rFSH), and luteal support with either ENDOMETRIN® (progesterone) Vaginal Insert 100 mg or progesterone-in-oil (PIO). The overall continuing pregnancy rate was 43.1 percent (n=143), with pregnancy rates of 46.7 percent for the MENOPUR® group (n=68) and 40.0 percent for the rFSH group (n=75). Results of the analysis indicate that MENOPUR® is effective in IVF cycles using a GnRH antagonist, and the efficacy of ENDOMETRIN® is equivalent to that of PIO for luteal support.

"We are very encouraged by these interim results," said Ed Trott, vice president, medical affairs. "We anticipate that the final results of the study will add to the growing body of evidence suggesting that hMG offers better embryo quality and higher implantation and live birth rates when compared to using rFSH alone."

About MENOPUR

MENOPUR® administered subcutaneously is indicated for the development of multiple follicles and pregnancy in the ovulatory patients participating in an ART program.

Important Safety Information

Only physicians thoroughly familiar with infertility treatment, including the risk of multiple births and adverse reactions, should prescribe MENOPUR®. MENOPUR®, like all gonadotropins, is a potent substance capable of causing mild to severe adverse reactions, including OHSS (overall incidence 3.8%), with or without pulmonary or vascular complications, in women undergoing therapy for infertility. MENOPUR® is contraindicated in women who have a high FSH level indicating primary ovarian failure; uncontrolled thyroid and adrenal dysfunction; an organic intracranial lesion such as a pituitary tumor; sex hormone dependent tumors of the reproductive tract and accessory organs; abnormal uterine bleeding of undetermined origin; ovarian cysts or enlargement not due to polycystic ovary syndrome; prior hypersensitivity to menotropins or MENOPUR®. MENOPUR® is not indicated in women who are pregnant. There are limited human data on the effects of menotropins when administered during pregnancy.

About ENDOMETRIN

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.

Important Safety Information

Only physicians thoroughly familiar with infertility treatment should prescribe ENDOMETRIN®. In clinical trials (n=808), adverse reactions that occurred at a rate greater than or equal to 2 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 2 percent. ENDOMETRIN® is expected to have adverse reactions similar to other drugs containing progesterone (breast tenderness, bloating, mood swings, irritability, and drowsiness). ENDOMETRIN® is contraindicated in women who have or have had previous allergic reactions to progesterone or any of the ingredients in ENDOMETRIN® ; a known missed abortion or ectopic pregnancy; liver disease; known or suspected breast cancer; active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.

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 MENOPUR®, BRAVELLE® (urofollitropin for injection, purified), REPRONEX® (menotropins for injection, USP), NOVAREL® (chorionic gonadotropin for injection, USP) 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 urology products includes FIRMAGON® (degarelix for injection) and PROSED® DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate). Ferring's orthopaedic product includes EUFLEXXA(TM) (1% sodium hyaluronic acid). Other products include ACTHREL® (corticorelin ovine triflutate for injection) and DESMOPRESSIN.

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

Source: Ferring Pharmaceuticals Inc