Vaginal Progesterone Is Equally Effective In Achieving Pregnancy Outcomes As Injectable Progesterone In Donor Egg Cycles

Main Category: Fertility
Also Included In: Women's Health / Gynecology;  Pregnancy / Obstetrics
Article Date: 16 Apr 2008 - 4:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

A retrospective analysis of anonymous oocyte (egg) donation cycles, comparing the pregnancy outcomes between vaginally-administered progesterone versus intramuscular (IM) progesterone injections, demonstrates that vaginally-administered progesterone and IM progesterone achieve equal pregnancy outcomes, according to data presented by Brian Berger, MD, Boston IVF, at the Pacific Coast Reproductive Society annual meeting in Rancho Mirage, CA. The retrospective study was supported by a grant from Columbia Laboratories, Inc. (NASDAQ:CBRX).

"We found no significant differences in pregnancy outcomes between patients treated with vaginal progesterone versus progesterone administered intramuscularly," said Dr. Berger. "Further, vaginal progesterone has the added advantage of avoiding painful intramuscular injections."

In 225 egg donor cycles, 105 patients received vaginally-administered progesterone (CRINONE® 8% (a bioadhesive progesterone gel)) and 120 received IM progesterone. The implantation rate was 43.8% for vaginal progesterone versus 37.1% for IM progesterone (p=0.175). Recipients treated with vaginal progesterone achieved a 58.1% pregnancy rate and a 51.4% delivery rate, versus a 53.3% pregnancy rate (p=0.503) and a 48.3% delivery rate (p=0.689) for patients receiving IM progesterone. The pregnancy loss rate was 10.5% for patients using vaginal progesterone and 10.8% for IM progesterone users (p=1.00).

"This study clearly demonstrates that vaginal progesterone gel achieves the same pregnancy outcomes as progesterone administered via an intramuscular injection. This is important confirmation that CRINONE® 8% offers patients an efficacious and more convenient option for providing progesterone support in infertility treatment," Berger added.

Boston IVF is one of America's most successful fertility centers, providing patients with unparalleled medical care and the best experience with the expertise of premier doctors and professional staff, who are affiliated with Harvard Medical School. It is world renowned for its highly successful and innovative infertility treatments, highest quality service, state-of-the-art methods, ongoing scientific research, and on-site complementary healthcare at its Domar Center.

About Progesterone and Luteal Phase Support

Progesterone is the pregnancy hormone that creates a healthy environment in a woman's uterus where a fertilized egg can implant and grow into a healthy baby. 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 latter part of a woman's menstrual cycle which is called the luteal phase. The luteal phase 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 ART treatment 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.

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 Assisted Reproductive Technology treatment for infertile women with progesterone deficiency. For more information, please visit http://www.columbialabs.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995

This press release contains forward-looking statements about Columbia Laboratories, Inc.'s expectations regarding the Company's strategic direction, prospects and future results, which statements are 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