Bleeding is Rare in IVF Patients Who Become Pregnant When Treated with a Combination of Vaginal Progesterone Gel and Estrogen

LIVINGSTON, N.J. & ATLANTA--(BUSINESS WIRE)--Oct 22, 2009 - A prospective, multi-center study demonstrated that in IVF (in vitro fertilization) cycles supplemented with once-daily dosing of Crinone® vaginal progesterone gel and Estrace® oral estrogen, vaginal bleeding is rare in patients who become pregnant. Bleeding does occur in approximately one-quarter of patients who do not become pregnant. These data were presented at the American Society for Reproductive Medicine (ASRM) annual meeting in Atlanta.

Vaginal bleeding is reported in some IVF cycles during the luteal phase (the end of a woman's menstrual cycle, when progesterone levels are significantly higher), and can be a major concern for women undergoing infertility treatment. This study, including 66 patients who became clinically pregnant and 53 patients who did not conceive, evaluated the effectiveness of the combination of Crinone with estrogen on luteal phase bleeding.

In a podium presentation, James P. Toner, MD, PhD, Atlanta Center for Reproductive Medicine, demonstrated that 36% of patients had spotting or bleeding associated with egg retrieval. No more than two (5%) of the pregnant patients bled on any day past egg retrieval. The combination of vaginal progesterone gel and estrogen appears to reduce the incidence of bleeding in IVF patients who become pregnant.

“By treating IVF patients with a combination of Crinone and Estrace, we may succeed in eliminating bleeding in those who achieve pregnancy and reduce the level of stress and concern for patients during this stage of their treatment cycle,” stated Dr. Toner. “We are continuing to collect data, including data from other centers that use either intramuscular progesterone or do not supplement their Crinone cycles with estradiol, to determine if bleeding rates are different with these other strategies for luteal support.”

This study was supported by a grant from Columbia Laboratories (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 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, and RepHresh® and Replens® by Lil' Drug Store Products, Inc; 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.

PROCHIEVE®, CRINONE® and STRIANT® are registered trademarks of Columbia Laboratories, Inc.

 

 

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Posted: October 2009

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