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Columbia Laboratories' Announces the Publication of Interim Results for Crinone 8% in 1184 IVF Patients.


Business Editors/Health & Medical Writers

NEW YORK--(BW HealthWire)--Nov. 1, 2000

-- The Clinical Pregnancy Rate was 35.2% Which was

Slightly Higher Than the Latest Set of Results (33.64%)

These Centers Reported to SART SART 1 Sexual assault response team, see there 2 Society for Assisted Reproductive Technology A voluntary organization dedicated to improving the quality and delivery of assisted reproduction 3 Standard acid reflux test, see there  --

Columbia Laboratories (AMEX AMEX

See: American Stock Exchange
:COB) today announced the publication in the journal Fertility and Sterility (vol. 74, no. 4, p. 836) of the interim results of an open-label, multi-center trial from 16 centers in the U.S. that had each completed research on at least 40 IVF IVF in vitro fertilization.

IVF
abbr.
in vitro fertilization


IVF 1 In vitro fertilization, see there 2. Intravascular fluid
 patients by June 1, 1999. The overall clinical pregnancy rate per embryo transfer embryo transfer
n.
After artificial insemination, the process by which the fertilized ovum is transferred at the blastocyst stage to the recipient's uterus.
 among Crinone users was 35.2%. The results were slightly higher than the latest set of results (33.64%) these centers reported to the Society of Assisted Reproductive Technologies (CDC-1997), excluding Crinone study patients.

With few exceptions, comparison of clinical pregnancy rate between Crinone users in this study and historical SART figures from each individual center showed similar or improved results (+/- 5% or greater increase). Women tolerated Crinone well, and over 90% of those patients questioned preferred Crinone to their previous forms of progesterone progesterone (prōjĕs`tərōn'), female sex hormone that induces secretory changes in the lining of the uterus essential for successful implantation of a fertilized egg.  therapy.

This data, plus the results of 5 smaller trials were presented last week in San Diego at the American Society for Reproductive Medicine (ASRM ASRM American Society for Reproductive Medicine (formerly: American Fertility Society)
ASRM Alberta Section of Rural Medicine
ASRM Assault Squadron Royal Marines
ASRM Abort Solid Rocket Motor
) Annual Meeting. All but one of these studies showed the same or an improved pregnancy rate when Crinone was used.


      1. Poster 175 - LL Saucedo - Controlled Prospective Randomized
study of Crinone 8% vs. Intramuscular Progesterone (IM P) 50mg.
      Crinone 8% - (n=37) Clinical Pregnancy Rate 30%
      IM P - (n=40) Clinical Pregnancy Rate 30%

      2. Poster 350 - C Coutifaris - Retrospective Study of Crinone 8%
vs. IM progesterone 50mg.
      Crinone 8% - (n=83) Clinical Pregnancy Rate 52%
      IM P - (n=60) Clinical Pregnancy Rate 43%.

      3. Poster 363 - SC Williams - Retrospective Study of Crinone 8%
vs. IM progesterone 50mg vs. Prometrium(R)200mg three times a day.
      Crinone 8% - (n=18) Clinical Pregnancy Rate 39%
      Prometrium - (n=47) Clinical Pregnancy Rate 30%
      IM P - (n=31) Clinical Pregnancy Rate 23%.

      4. Poster 367 - M Ludwig - Randomized Prospective Study of Crinone
8% vs. Utrogest(R)(Prometrium).
      Crinone 8% - (n=73) Clinical Pregnancy Rate 24.7%
      Utrogest - (n=53) Clinical Pregnancy Rate 17%.

      5. Oral - AM Propst Prospective Randomized Study of Crinone 8% vs.
IM progesterone 50mg.
      Crinone 8% - (n=109) Clinical Pregnancy Rate 30.4%
      IM P - (n=99) Clinical Pregnancy Rate 48.5%.


"The preponderance of data demonstrates that Crinone 8% is at least as effective as IM progesterone and that it is overwhelmingly preferred by women," said William J. Bologna Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. .

Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to research and development of women's health Women's Health Definition

Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues.
 care products, including those intended to treat infertility, dysmenorrhea dysmenorrhea

Pain or cramps before or during menstruation. In primary dysmenorrhea, caused by endocrine imbalances, severity varies widely. Irritability, fatigue, backache, or nausea may also occur.
, endometriosis endometriosis (ĕn'dəmē'trē-ō`sĭs), a condition in which small pieces of the endometrium (the lining of the uterus) migrate to other places in the pelvic area. , hormonal deficiencies. Columbia is also developing hormonal products for men and a buccal buc·cal
adj.
1. Of, relating to, adjacent to, or in the direction of the cheek.

2. Of or relating to the mouth cavity.


buccal
 delivery system for peptides. Columbia's products primarily utilize the company's patented bioadhesive delivery technology.

This press release contains statements which constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Those statements include statements regarding the intent, belief or current expectations of the company and its management team. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those projected in the forward-looking statements. Such risks and uncertainties include, among other things, competitive economic, and regulatory factors in the pharmaceutical and health care 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.
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No portion of this article can be reproduced without the express written permission from the copyright holder.
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Date:Nov 1, 2000
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