CRINONE(R) 8% Is Equally Effective And Significantly Better Tolerated Than Intramuscular Progesterone; Similar Pregnancy Rates And Outcomes Reported

Main Category: Fertility
Also Included In: Pregnancy / Obstetrics
Article Date: 22 Oct 2009 - 6:00 PDT

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Researchers from Brigham & Women's Hospital in Boston presented data from the largest, prospective, randomized clinical study to date comparing any vaginal progesterone to intramuscular injections of progesterone (IM progesterone) for infertility treatment. Results from this study demonstrated that CRINONE vaginal progesterone gel is equally effective and significantly better tolerated than IM progesterone for luteal phase support in IVF-ET (In Vitro Fertilization and Embryo Transfer) cycles. These data were presented at the American Society for Reproductive Medicine (ASRM) annual meeting in Atlanta.

"These data are quite compelling and represents the most comprehensive comparison of these two routes of administration for progesterone therapy," said Elena H. Yanushpolsky, MD, Director, Reproductive Surgery, Center for Reproductive Medicine, Brigham & Women's Hospital. "When I presented these data to my colleagues, the results were significant enough to convince our physicians to switch their protocols for luteal phase support from IM progesterone to CRINONE for our assisted reproductive technology (ART) cycles."

Over 400 study participants were randomized to receive CRINONE (n=206) or IM progesterone (n=201), 48 or 24 hours after egg retrieval, respectively. No differences were observed between CRINONE and the IM progesterone groups in overall pregnancy rates, implantation, ongoing pregnancy or failed pregnancy rates. Patients were also surveyed at the completion of the cycle, and reported that CRINONE was significantly better tolerated than IM progesterone (4.4 versus 2.5 on a 5 point scale; p=0.0001).

Dr. Yanushpolsky also presented data from an additional analysis from this study that evaluated the incidence of luteal phase bleeding (LPB) in IVF-ET cycles supplemented with either CRINONE vaginal progesterone gel or intramuscular (IM) progesterone. Similar incidence of LPB was observed in both CRINONE and IM progesterone groups. However, a delay in the onset of bleeding (menses) was noted in the non-pregnant group that received IM progesterone. Ongoing and failed pregnancy rates were similar between the CRINONE and IM progesterone groups.

"CRINONE vaginal gel is equally effective and significantly better tolerated than IM progesterone, and is the clear choice for progesterone supplementation," added Dr. Yanushpolsky.

This study was supported in part by a grant from Columbia Laboratories, Inc. (Nasdaq: CBRX)

About Progesterone and Luteal Phase Support

Progesterone is a hormone naturally found in a woman's body, which creates a healthy environment in the uterus, where a fertilized egg can implant and grow into a healthy pregnancy. Most women undergoing infertility treatment need additional progesterone, to help prepare the uterus for implantation and development of a fertilized egg.

Before ovulation, progesterone levels in a woman's body remain relatively low, but rise after ovulation, during the luteal phase. The luteal phase is the latter part of a woman's menstrual cycle. It begins with the production of progesterone and ends with either pregnancy or menstruation, when the uterus sheds its lining. During pregnancy, progesterone helps to maintain the lining of the uterus, providing necessary nutrients to support and nurture a fertilized egg.

About CRINONE® 8%

CRINONE® 8% was the first FDA-approved natural progesterone for progesterone supplementation or replacement as part of Assisted Reproductive Technology (ART) treatments for infertile women with progesterone deficiency, and is the only once a day treatment. CRINONE 8% is safe for use during pregnancy, and has been safely used for a decade by tens of thousands of women globally to help sustain pregnancy in the first trimester. Its unique bioadhesive delivery system provides controlled and sustained release of progesterone directly where it is needed. For more information, please visit http://www.crinoneusa.com.

The most common side effects of CRINONE 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. CRINONE 8% is contraindicated in patients with active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders, missed abortion, undiagnosed vaginal bleeding, liver dysfunction or disease, and known or suspected malignancy of the breast or genital organs.

Source
Columbia Laboratories