PARSIPPANY, N.J.--(BUSINESS WIRE)--Ferring Pharmaceuticals announced today a publication in Fertility and Sterility highlighting MEGASET-HR, a 620 patient, non-inferiority trial comparing Menopur (menotropins for injection) to rFSH, which suggests an opportunity to individualize treatment for predicted high responders. The MEGASET-HR study met its primary endpoint, with Menopur-treated patients experiencing a 35.5% OPR per cycle start after fresh transfer, as defined by the presence of at least one intrauterine pregnancy with a fetal heartbeat at 10-11 weeks gestation (8-9 weeks after fresh blastocyst transfer), while rFSH-treated patients reported an OPR of 30.7%.
“I am very pleased to partner with Ferring on this clinical study. The study aims to help identify how we can provide care for what can be a challenging patient population to treat,” said Craig Witz, M.D., Reproductive Endocrinologist at the Houston Fertility Institute and lead researcher of the study. “The intriguing data from this study is the relationship between cumulative live birth rate and the number of transfers, early pregnancy loss and safety data. As physicians, we are always looking for opportunities to personalize care for the patients that we see on a day-to-day basis and are excited about these results."
Overall, cumulative live birth rates per cycle start were similar with Menopur and rFSH at 50.6% and 51.5% respectively. However, compared to rFSH, patients randomized to Menopur had a lower incidence of ovarian hyperstimulation syndrome (OHSS), a condition with potentially severe complications, 21.4% vs. 9.7% respectively. Additionally, a lower cumulative (fresh and frozen transfers) early pregnancy loss rate was reported in the Menopur treatment arm (14.5%) vs. rFSH (25.5%).
“The results of this comparative clinical trial offer new insights into treatment protocols for predicted high-responder patients undergoing controlled ovarian stimulation as part of an assisted reproductive technology program,” said Gaurang Daftary, M.D., Ferring Pharmaceutical’s Senior Director of Medical Affairs. “At Ferring, we are committed to science that generates data that may help advance therapeutic personalization. Our goal is to make having a family safe and accessible for those trying to conceive.”
About the MEGASET-HR Study
The MEGASET-HR study is a multicenter, randomized, open-label, assessor-blind, non-inferiority study designed to compare the safety and efficacy of Menopur (highly purified menotropin, or HP-hMG) vs. recombinant follicle stimulating hormone (rFSH) in a predicted high responder population undergoing in vitro fertilization (IVF). The study included 620 ovulatory women between the ages of 21 and 35, with a body mass index (BMI) of 18-30 kg/m2, infertility≥1 year and serum anti-Müllerian hormone (AMH) ≥ 5 ng/mL. Subjects were randomized in a 1:1 ratio to a 150 IU start dose of Menopur or rFSH in a Gonadotropin-releasing hormone (GnRH) antagonist cycle. Dose adjustments were permitted starting on the sixth day of stimulation based on follicular response. Dosing could be adjusted every day by 75 IU per day with a maximum and minimum gonadotropin dose of 300 and 75 IU/day, respectively, for no more than 20 days. The primary non-inferiority endpoint, ongoing pregnancy rate, was defined as the presence of at least 1 intrauterine pregnancy with a detectable fetal heartbeat at 10-11 weeks gestation (8-9 weeks after blastocyst transfer in the fresh cycle).
Menopur® (menotropins for injection), administered subcutaneously, is indicated for the development of multiple follicles and pregnancy in ovulatory patients participating in an Assisted Reproductive Technology (ART) program.
Important Safety Information
Menopur is contraindicated in women who have: a high FSH level indicating primary ovarian failure, presence of uncontrolled non-gonadal endocrinopathies, tumors of the pituitary gland or hypothalamus, sex hormone dependent tumors of the reproductive tract and accessory organs, abnormal uterine bleeding of undetermined origin, ovarian cysts or enlargement of undetermined origin, not due to polycystic ovary syndrome, or prior hypersensitivity to menotropins or Menopur. Menopur is not indicated in women who are pregnant and may cause fetal harm when administered to a pregnant woman.
Menopur should only be used by physicians who are thoroughly familiar with infertility problems. Menopur is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS), with or without pulmonary or vascular complications, in women undergoing therapy for infertility. Ovarian torsion has been reported after gonadotropin treatment. Serious pulmonary conditions and thromboembolic events have been reported with Menopur. There have been infrequent reports of ovarian neoplasms with Menopur. Multiple pregnancies, spontaneous abortion, congenital malformations and ectopic pregnancies have occurred following treatment with Menopur.
The most common adverse reactions (≥2%) in ART include: abdominal cramps; abdomen enlarged; abdominal pain; headache; injection site pain and reaction; injection site inflammation; OHSS.
Please see here for full Prescribing Information for Menopur.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a research-driven biopharmaceutical company devoted to identifying, developing and marketing innovative products in the fields of reproductive medicine, maternal health, urology, gastroenterology, endocrinology, and orthopaedics. For more information, call 1-888-FERRING (1-888-337-7464); visit www.FerringUSA.com
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