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New Approach to Progesterone Supplementation in ART Revealed in Recently Published White Paper

April 13, 2009

Expert Panel: Vaginal Progesterone Preferred for Luteal Support in ART

PARSIPPANY, N.J., April 13 /PRNewswire/ — Ferring Pharmaceuticals, a leader in the infertility market with the broadest portfolio of treatments in the U.S., today released a white paper titled, Recommendations on the Use of Vaginal Progesterone for Luteal-Phase Support in Assisted Reproductive Technology (ART) Procedures. The paper was drafted after an expert panel of renowned reproductive endocrinologists from the U.S. and Europe convened in New York City on December 19, 2008 to discuss the utility of vaginal progesterone for luteal phase support during ART. After critical review and discussion of personal clinical data and experience with progesterone in ART, the experts concluded that vaginal progesterone should be the standard-of-care when considering progesterone formulations in ART and that vaginal progesterone provides improved patient comfort over intramuscular (IM) progesterone without compromising pregnancy rates.

The objective of the meeting was to reach a consensus based on physician experience regarding which progesterone formulation is preferred from a clinical and patient-acceptance perspective. The vaginal progesterone formulations that were compared with intramuscular progesterone included: Crinone(R), Prometrium(R) oral tablets, compounded vaginal suppositories and capsules, and ENDOMETRIN(R) (progesterone) Vaginal Insert 100 mg – the most recent progesterone supplement to be approved by the U.S. Food and Drug Administration (FDA).

“The clear take-away from this expert roundtable meeting is that both physicians and patients prefer the comfort and convenience of vaginal progesterone formulations,” said Alan Penzias, MD, reproductive endocrinologist and surgical director at Boston IVF. “Before vaginal progesterone formulations were introduced, IM progesterone was the standard-of-care for luteal support, however, recently introduced vaginal formulations such as ENDOMETRIN have demonstrated equivalent pregnancy rates to IM. This allows us to confidently prescribe a progesterone supplement that is not only effective, but can also enhance a patient’s quality of life.”

One of the most recent studies published that supports equivalent pregnancy rates between vaginal progesterone and IM progesterone was presented by Angeline Beltsos, MD, medical director of Fertility Centers of Illinois in Chicago and one of the expert panelists, at the 2008 American Society for Reproductive Medicine (ASRM) meeting. The analysis evaluated serum progesterone levels and pregnancy outcomes with ENDOMETRIN vaginal inserts (n=568) compared with IM progesterone (n=751). Results from the study showed equivalent pregnancy rates with vaginal progesterone versus IM progesterone. (1)

Key Findings from the Roundtable

  • Luteal phase support should be initiated on the evening of or the day after oocyte retrieval. It is critical for the first two weeks and should continue for six to eight weeks after a positive pregnancy test is obtained.

  • Medical literature strongly supports that vaginal progesterone is as efficacious as IM progesterone, in terms of pregnancy rates.

  • Vaginal progesterone likely provides improved patient comfort than IM progesterone, without sacrificing efficacy.

  • Patients should be reassured that minimal bleeding with vaginal progesterone does not affect pregnancy outcomes. Bleeding is the result of not becoming pregnant and not necessarily the cause.

  • The measurement of serum progesterone has low clinical utility when using progesterone in luteal support.

  • Pharmaceutical grade FDA-approved vaginal progesterone products are preferred over pharmacy-compounded products.

  • The use of vaginal progesterone should be emphasized in the training of future RE’s and IVF nurses in the area of ART.

In the overall findings, the panel recommended that vaginal progesterone should be the standard-of-care when considering progesterone formulations in ART.

About ENDOMETRIN

ENDOMETRIN(R) 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(R). In clinical trials (n=808), adverse reactions that occurred at a rate greater than or equal to 2% 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%. ENDOMETRIN(R) is expected to have adverse reactions similar to other drugs containing progesterone (breast tenderness, bloating, mood swings, irritability, and drowsiness). ENDOMETRIN(R) is contraindicated in women who have or have had previous allergic reactions to progesterone or any of the ingredients in ENDOMETRIN(R); 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 in the U.S. The Company markets MENOPUR, BRAVELLE, REPRONEX(R) (menotropins for injection, USP), NOVAREL(R) (chorionic gonadotropin for injection, USP) and ENDOMETRIN(R) (progesterone) Vaginal Insert 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(R) (1% sodium hyaluronic acid) and PROSED(R) DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate). Other products include: ACTHREL(R) (corticorelin ovine triflutate for injection), DESMOPRESSIN and DEGARELIX for injection.

The Ferring Group specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, gastroenterology, obstetrics/ gynecology, infertility and orthopaedics. For more information, call 888-337-7464 or visit www.ferringusa.com or www.ferringfertility.com.

Please visit www.ferringfertility.com for Full Prescribing Information for ENDOMETRIN.

  1. Martin-Johnston M, Beltsos A, Robertson A, et al. Luteal phase support with Endometrin(R) vs. progesterone in oil in in vitro fertilization cycles. Fertil Steril. 2008;90 (Suppl 1): S459.

Crinone is a registered trademark of Columbia Laboratories, Inc.

Prometrium is a registered trademark of Solvay Pharmaceuticals

SOURCE Ferring Pharmaceuticals


Source: newswire



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