Researchers from Brigham & Women's Hospital in Boston today presented data demonstrating that women undergoing In Vitro Fertilization (IVF) and using either vaginally-administered progesterone gel (CRINONE® 8%) or progesterone injected intramuscularly for luteal phase supplementation, reported no difference in ongoing pregnancy rates when they experienced luteal phase bleeding (LPB). LPB is defined as any bleeding or spotting between embryo transfer and first pregnancy test. LPB occurred with both CRINONE and intramuscular (IM) progesterone injections. These data were presented by Elena H. Yanushpolsky, MD, at the American Society for Reproductive Medicine annual meeting in San Francisco.

This planned interim analysis of an ongoing, prospective, randomized, controlled study compared the incidence of LPB in IVF cycles supplemented with either CRINONE vaginal progesterone gel or IM progesterone for luteal phase support. Pregnancy outcome was comparable between CRINONE and IM progesterone users.

"The ongoing pregnancy rates among patients with luteal phase bleeding were no different when using CRINONE or IM progesterone," said Dr. Yanushpolsky, Director, Reproductive Surgery, Center for Reproductive Medicine, Brigham & Women's Hospital. "LPB is a poor prognostic sign for ongoing pregnancy in IVF, regardless of the type of progesterone used."

"The trend toward a greater incidence of LPB in the CRINONE versus IM progesterone group was limited to those IVF cycles that were unsuccessful (the non-pregnant patients and those who experienced pregnancy loss)," Yanushpolsky added. "Patients using CRINONE may have an earlier indication of a successful versus an unsuccessful pregnancy following an IVF cycle than those using IM progesterone. IM progesterone delays menstrual bleeding in unsuccessful cycles giving patients a false sense of hope."

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.

This study was supported in part by a grant from EMDSerono Corporation.

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

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.

CRINONE® is a registered trademark of Columbia Laboratories, Inc.

About Columbia Laboratories

Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to the development and commercialization of women's healthcare and endocrinology products that use its novel bioadhesive drug delivery technology. Columbia markets CRINONE® 8% (progesterone gel) in the United States for progesterone supplementation as part of ART treatments for infertile women with progesterone deficiency. For more information, please visit

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, which statements may be indicated by the words "will," "plan," "expect" and similar expressions. Such forward-looking statements are subject to 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 successful marketing of CRINONE® 8% (progesterone gel) in the U.S.; the timely and successful development of new products; the impact of competitive products and pricing; 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 publicly update any forward-looking statements.

Columbia Laboratories