October 26, 2010
ENDOMETRIN VAGINAL INSERTS DEMONSTRATE COMPARABLE EFFICACY TO INTRAMUSCULAR INJECTIONS OF PROGESTERONE-IN-OIL FOR LUTEAL SUPPORT IN GNRH IVF CYCLES
Ferring Pharmaceuticals Presents Study Results at 66th American Society for Reproductive Medicine Annual Meeting
DENVER – October 26, 2010 – Ferring Pharmaceuticals Inc. presented study results demonstrating that ENDOMETRIN® (progesterone) Vaginal Insert provides effective luteal support compared to intramuscular (IM) progesterone-in-oil (PIO) in patients undergoing in vitro fertilization (IVF) using gonadotropin releasing hormone (GnRH) antagonist. The results were presented at the 66th Annual Meeting of the American Society for Reproductive Medicine (ASRM) in Denver, October 23 – 27, 2010.
According to the Society for Assisted Reproductive Technology (SART), approximately 140,000 IVF treatment cycles are performed each year. Since natural progesterone production may be compromised by IVF, progesterone supplementation is believed to be necessary to provide the proper support for implantation and the early stages of pregnancy. Studies have shown that luteal support with ART can result in increased pregnancy rates.1
In the multicenter, randomized, open-label exploratory study, patients were randomized prior to stimulation with either MENOPUR® (menotropins for injection, USP) or rFSH and luteal support with either ENDOMETRIN (n=84) or PIO (n=81) for nine days. The continuing pregnancy rate was 44% in the ENDOMETRIN group and 46.9% for the PIO group. The analysis showed that vaginal progesterone inserts provide effective luteal support in IVF compared to IM PIO.
“We are very encouraged by the results of this prospectively designed, open-label study which was conducted at six major IVF centers across the U.S.,” said Charles E. Miller, MD, lead study investigator, The Advanced IVF Institute, Illinois. “ENDOMETRIN was well-tolerated and provides a more patient-friendly form of luteal support with comparable efficacy to PIO.”
With more than three years of experience on the market, ENDOMETRIN is the number one prescribed progesterone product indicated for ART.*
ENDOMETRIN® (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 program for infertile women.
Important Safety Information
ENDOMETRIN should not be used in individuals with any of the following conditions: previous allergic reactions to progesterone or any of the ingredients of ENDOMETRIN, 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. The physician should be alert to earliest signs of myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism (venous thromboembolism or pulmonary embolism), thrombophlebitis, or retinal thrombosis. ENDOMETRIN should be discontinued if any of these are suspected.
Patients with a history of depression need to be closely observed. Consider discontinuation if symptoms worsen.
ENDOMETRIN should not be recommended for use with other vaginal products (such as antifungal products) as this may alter progesterone release and absorption from the vaginal insert.
The most common adverse reactions reported (greater than 5%) were post-oocyte retrieval pain, abdominal pain, nausea, and ovarian hyperstimulation syndrome.
MENOPUR® (menotropins for injection), administered subcutaneously is indicated for the development of multiple follicles and pregnancy in the ovulatory patients participating in an ART program.
Important Safety Information
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, or prior hypersensitivity to menotropins or MENOPUR. MENOPUR is not indicated in women who are pregnant.
MENOPUR should only be used by physicians who are thoroughly familiar with infertility problems. MENOPUR is a potent gonadotropic substances capable of causing Ovarian Hyperstimulation Syndrome (OHSS) (overall IVF incidence of 3.8%), with or without pulmonary or vascular complications, in women undergoing therapy for infertility. Serious pulmonary conditions and thromboembolic events have been reported with MENOPUR.
Multiple pregnancies have occurred following treatment with MENOPUR.
The most common adverse reactions (≥10%) reported in IVF clinical trials (N=499) of MENOPUR were headache, abdominal pain, and nausea.
About Ferring Pharmaceuticals Inc.
Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals offers a line of products in the U.S. market. They include: BRAVELLE® (urofollitropin for injection, purified), MENOPUR® (menotropins for injection, USP) and REPRONEX® (menotropins for injection, USP), NOVAREL® (chorionic gonadotropin for injection, USP), ENDOMETRIN® (progesterone) Vaginal Insert, 100 mg, LYSTEDA™ (tranexamic acid) tablets, FIRMAGON® (degarelix for injection), PROSED® DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, and EUFLEXXA® (1% sodium hyaluronate).
Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, orthopaedics, gastroenterology, obstetrics/gynecology, and infertility. For more information, call 1-888-FERRING (1-888-337-7464) or visit www.FerringUSA.com.
Please visit www.ferringfertility.com for Full Prescribing Information for MENOPUR and ENDOMETRIN.
* Source: According to data from Wolters Kluwer Pharma Solutions, Source® Pharmaceutical Audit Suite, January 2010 to July 2010, inclusive of reproductive endocrinologist specialty only.
|1||Daya S, Gunby J. Luteal phase support in assisted reproduction cycles. Cochrane Database Syst Rev. 2004;(3): CD004830.|