First New Progesterone Supplement in a Decade Debuts As a More Convenient
PARSIPPANY, N.J., Nov. 12 /PRNewswire/ -- According to a nationwide survey of 350 women conducted on the American Fertility Association (AFA) Web site, few women undergoing an Assisted Reproductive Technology (ART) treatment for infertility, such as in vitro fertilization (IVF), realize that as they approach the finish line comes another treatment -- progesterone supplementation. This extra boost of progesterone, which supports embryo implantation and early pregnancy, is extremely important for a successful pregnancy. The survey, Progesterone Therapy: The Patient Perspective, was supported by an educational grant from Ferring Pharmaceuticals.
"Progesterone supplementation is a rigorous process that women in ART treatments must undergo for up to 10 weeks to improve their chances of pregnancy," said Pamela Madsen, AFA Executive Director. "One clear and disturbing conclusion from the survey is that there should be far more dialog between patients and their doctor about this critical aspect of treatment and the various therapy choices."
Progesterone Therapy: The Patient Perspective
Surprisingly, many patients did not know about progesterone therapy and product options before they started treatment. For 44 percent, their doctor or nurse did not explain progesterone therapy. Nearly all (94 percent) said they had no input into the selection of a product. Typically, they use whatever the doctor recommends.
Most of the women surveyed (86 percent) were not completely satisfied with their progesterone treatment, and 80 percent feel there is a need for a more patient-friendly option. Nearly all said that if they knew there was a new product available that was just as effective as current therapies, but more comfortable and convenient, they would ask their doctor about it.
The majority (nearly two-thirds) used intramuscular progesterone-in-oil injections typically given by a partner, which can be quite painful. In fact, 69 percent found them painful, 61 percent experienced moderate to very severe side effects, and 71 percent said the injections were inconvenient. Typical descriptions were: "a painful necessary evil," "like injecting yourself with mud," and "Big needle. Shot site can get very sore and expect bruising."
The majority of women (78 percent) who used progesterone suppositories said they leaked. Thirty four percent said the suppositories caused irritation and nearly half found them awkward to administer. A third experienced moderate to very severe side effects.
Most women who took gels and vaginal capsules found them messy and leaky. Of the 11 percent (37 people) who used a progesterone gel, more than three- quarters experienced gel build-up, a common problem with this form. Moderate to very severe side effects occurred with 40 percent of gel users, and one in three (28 percent) women who took progesterone capsules vaginally.
A new progesterone supplement, ENDOMETRIN(R) (progesterone) Vaginal Insert, 100 mg, was recently approved by the U.S. Food and Drug Administration (FDA), giving women the first new progesterone treatment option in a decade. Developed as a more convenient, patient-friendly treatment, ENDOMETRIN tablets are vaginally inserted with a disposable applicator two or three times daily, from the day of oocyte retrieval to about 10 weeks of pregnancy. Results of the largest IVF trial in the world, conducted at 25 U.S. centers in 1,211 women, showed that ENDOMETRIN provides unprecedented support in the final phase of ART treatment, based on high continuing pregnancy and live birth rates.
Research by Ferring Pharmaceuticals, manufacturer of ENDOMETRIN, found that what patients liked most about ENDOMETRIN is that it is easy to administer, convenient, painless (no injection), and less messy than suppositories. Nearly 80 percent would recommend it to a friend.
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 to other drugs containing progesterone (breast tenderness, bloating, mood swings, irritability, and drowsiness).
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(R) (urofollitropin for injection, purified), MENOPUR(R) (menotropins for injection, USP), REPRONEX(R) (menotropins for injection, USP), NOVAREL(R) (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 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. For more information, call 888-337-7464 or visit http://www.ferringusa.com or http://www.ferringfertility.com.
Please contact Andrea Preston for full prescribing information for ENDOMETRIN.
|SOURCE Ferring Pharmaceuticals|
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