LIVINGSTON, N.J. & ATLANTA--(BUSINESS WIRE)--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 - News)
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 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.
About Columbia Laboratories
Columbia Laboratories, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the women’s healthcare and endocrinology markets that use its novel bioadhesive drug delivery technology. Columbia markets CRINONE® 8% (progesterone gel) in the United States for progesterone supplementation as part of an ART treatment for infertile women with progesterone deficiency. The Company also markets STRIANT® (testosterone buccal system) for the treatment of hypogonadism in men. The Company’s partners market CRINONE® 8%, STRIANT®, and three other products to additional U.S. and foreign markets. The Company is conducting, in collaboration with the NIH, the PREGNANT (PROCHIEVE® Extending GestatioN A New Therapy) Study of PROCHIEVE® 8% to reduce the risk of preterm birth in women with a short cervix at mid-pregnancy. For more information, please visit www.columbialabs.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This press release may contain forward-looking statements about Columbia Laboratories, Inc.’s expectations regarding the Company’s strategic direction, prospects and future results, and clinical research programs, which statements are indicated by the words “will,” “plan,” “expect” and similar expressions. Such forward-looking statements involve certain risks and uncertainties; actual results may differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to, the following: the successful marketing of CRINONE® 8% (progesterone gel) and STRIANT® (testosterone buccal system) in the U.S.; the successful marketing of CRINONE® 8% by Merck Serono; the timely and successful development of PROCHIEVE® 8% to reduce the risk of preterm birth in women with a short cervix in mid-pregnancy; the timely and successful completion of the ongoing Phase III PREGNANT (PROCHIEVE® Extending GestatioN A New Therapy) Study of PROCHIEVE® 8% in short cervix patients; success in obtaining acceptance and approval of new products and new indications for current products by the FDA and international regulatory agencies; our ability to obtain financing in order to fund our operations and repay our debt as it comes due; the impact of competitive products and pricing; the strength of the U.S. dollar relative to international currencies, particularly the Euro; competitive economic and regulatory factors in the pharmaceutical and healthcare industry; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia’s reports filed with the Securities and Exchange Commission. Columbia Laboratories undertakes no obligation to update any forward-looking statements.
CRINONE®, PROCHIEVE®, and STRIANT® are registered trademarks of Columbia Laboratories, Inc.
Investors:Columbia Laboratories, Inc.Lawrence A. Gyenes, 973-486-8860Senior Vice President, CFO & TreasurerORRx Communications Group, LLCMelody A. Carey, 917-322-2571ORMedia:Cella CommunicationsGina Cella, 781-334-4692ginacella@comcast.net
