Navigation Links
Columbia Laboratories and Watson Announce Publication of Positive Phase III PROCHIEVE® Vaginal Progesterone Gel Study Results
Date:4/6/2011

his important data broadly available for review by the scientific and medical community, we can work to educate health care providers on the benefits of cervical screening and ensure it becomes a standardized component of the prenatal care regimen, ensuring that pregnant women at potential risk are identified.  We are committed to working with Columbia to submit the NDA to FDA, and to work closely to achieve a thorough review of the data which we believe will ultimately support approval of this potential therapy."

Trial Design and ResultsThe PREGNANT (PROCHIEVE Extending GestatioN A New Therapy) study was designed to evaluate the efficacy and safety of PROCHIEVE® (progesterone gel) to reduce the risk of preterm birth in women with a short cervical length as measured by transvaginal ultrasound between 19 and <24 weeks of gestation.  This double-blind, placebo-controlled study enrolled 465 healthy pregnant women between the ages of 15 and 45 at 44 sites in 10 countries.  Nearly half the subjects were based in the U.S.  Subjects were randomly assigned to receive either PROCHIEVE or placebo vaginal gel once daily from 20-24 weeks gestation until 37 weeks gestation, preterm rupture of membranes or delivery, whichever occurred first.  Women self-administered the progesterone gel study drug or gel placebo once daily in the morning.

The primary endpoint was a reduction in the rate of preterm birth before 33 weeks gestation.  This endpoint was chosen because the highest frequency of neonatal morbidity occurs with preterm neonates delivered prior to this gestational age. The incidence of preterm births was also evaluated before 28, 35 and 37 weeks gestation.  Analysis was by intention to treat, including all women randomized, and excluding patients lost to follow-up.

Results showed that women treated with PROCHIEVE had a significantly lower risk of preterm birth before 33 weeks gestation compared to those who
'/>"/>

SOURCE Watson Pharmaceuticals, Inc.; Columbia Laboratories, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Columbia University Medical Center and Rosetta Genomics Announce Columbia Universitys Submission of the First Cancer Diagnostic Test Based on Rosetta Genomics Proprietary MicroRNA Technology for Approval to the New York State Department of Health Clinica
2. Terumo Heart, Inc. Reports Clinical Progress in the DuraHeart(TM) U.S. Pivotal Trial as NewYork-Presbyterian Hospital/Columbia University Medical Center Implants First Patient
3. Watson Confirms Columbia Laboratories Filing of Definitive Proxy Relating to Watsons Acquisition of U.S. Rights to CRINONE® Progesterone Gel Product Line
4. Watson Confirms Columbia Laboratories Shareholder Approval of Proposed Acquisition of Progesterone-related Assets
5. Watson Completes Acquisition of CRINONE® and PROCHIEVE® Product Line and Shares of Columbia Laboratories
6. HealthWarehouse.com Partners with Columbia Medical Associates to Bring Affordable Healthcare to Washington State
7. Columbia University Students Learn About Pharmacy Benefit Management From Prime Therapeutics President and CEO
8. Columbia Laboratories to Discuss Fourth Quarter and Year End 2010 Financial Results on March 10, 2011, Conference Call
9. Sanofi-aventis Enters Into Research Collaboration With Columbia University to Develop New Diabetes Treatments
10. Daiichi Sankyo and Forest Laboratories Finalize Contract for Co-Promotion of AZOR(TM)
11. Forest Laboratories, Inc. and Gedeon Richter Announce Results of Phase II-B Study for RGH-188 as a Treatment for Schizophrenia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/27/2015)... Levi & Korsinsky announces it has commenced ... ) concerning possible violations of federal securities laws. The ... connection with its study of the drug OHR-102. To ... contact Joseph E. Levi, Esq. either via ... (212) 363-7500, toll-free: (877) 363-5972. Levi & ...
(Date:3/27/2015)... MONTREAL , March 27, 2015 /CNW Telbec/ - ... Research-Based Pharmaceutical Companies (Rx&D), welcomes the 2015-2016 ... of a working group on the biopharmaceutical industry. However, ... medicines budget. "We commend the government,s intent ... the announcement of measures to promote Quebec,s ...
(Date:3/27/2015)... The Temple Health & Bioscience District (THBD) today announced it ... South First St. in the Temple Medical and Education District ... of Temple to receive funding for redevelopment. Located ... Health Care System, the new facility will enable THBD to ... life science companies. Temple ...
Breaking Medicine Technology:Quebec 2015-2016 Budget: Rx&D welcomes fiscal discipline and biopharma working group, but the decrease in government spending on medicines is questioned 2Quebec 2015-2016 Budget: Rx&D welcomes fiscal discipline and biopharma working group, but the decrease in government spending on medicines is questioned 3Temple Health & Bioscience District Relocates, Offers Office And Lab Space To Biotech Companies 2
... NEW YORK, Oct. 14 Reportlinker.com announces that ... its catalogue: Colorectal Cancer - ... Forecasts and Treatment Analysis to 2020 ... - Brazil, China, India and Russia (BRIC) Drug ...
... Company (NYSE: LLY ) today announced that a ... medications, FORTEO® [teriparatide (rDNA origin) injection] and EVISTA® (raloxifene HCl ... and Mineral Research (ASBMR) 2010 Annual Meeting from October 15-19 ... TransPharma Medical Ltd., Lilly conducted a Phase II study and ...
Cached Medicine Technology:Reportlinker Adds Colorectal Cancer - Brazil, China, India and Russia (BRIC) Drug Drug Forecasts and Treatment Analysis to 2020 2Reportlinker Adds Colorectal Cancer - Brazil, China, India and Russia (BRIC) Drug Drug Forecasts and Treatment Analysis to 2020 3Reportlinker Adds Colorectal Cancer - Brazil, China, India and Russia (BRIC) Drug Drug Forecasts and Treatment Analysis to 2020 4Reportlinker Adds Colorectal Cancer - Brazil, China, India and Russia (BRIC) Drug Drug Forecasts and Treatment Analysis to 2020 5Reportlinker Adds Colorectal Cancer - Brazil, China, India and Russia (BRIC) Drug Drug Forecasts and Treatment Analysis to 2020 6Reportlinker Adds Colorectal Cancer - Brazil, China, India and Russia (BRIC) Drug Drug Forecasts and Treatment Analysis to 2020 7Reportlinker Adds Colorectal Cancer - Brazil, China, India and Russia (BRIC) Drug Drug Forecasts and Treatment Analysis to 2020 8Reportlinker Adds Colorectal Cancer - Brazil, China, India and Russia (BRIC) Drug Drug Forecasts and Treatment Analysis to 2020 9Reportlinker Adds Colorectal Cancer - Brazil, China, India and Russia (BRIC) Drug Drug Forecasts and Treatment Analysis to 2020 10Reportlinker Adds Colorectal Cancer - Brazil, China, India and Russia (BRIC) Drug Drug Forecasts and Treatment Analysis to 2020 11Reportlinker Adds Colorectal Cancer - Brazil, China, India and Russia (BRIC) Drug Drug Forecasts and Treatment Analysis to 2020 12Reportlinker Adds Colorectal Cancer - Brazil, China, India and Russia (BRIC) Drug Drug Forecasts and Treatment Analysis to 2020 13Reportlinker Adds Colorectal Cancer - Brazil, China, India and Russia (BRIC) Drug Drug Forecasts and Treatment Analysis to 2020 14Reportlinker Adds Colorectal Cancer - Brazil, China, India and Russia (BRIC) Drug Drug Forecasts and Treatment Analysis to 2020 15New FORTEO® and EVISTA® Data to be Presented at Premiere Scientific Meeting for Bone and Mineral Research 2New FORTEO® and EVISTA® Data to be Presented at Premiere Scientific Meeting for Bone and Mineral Research 3New FORTEO® and EVISTA® Data to be Presented at Premiere Scientific Meeting for Bone and Mineral Research 4New FORTEO® and EVISTA® Data to be Presented at Premiere Scientific Meeting for Bone and Mineral Research 5New FORTEO® and EVISTA® Data to be Presented at Premiere Scientific Meeting for Bone and Mineral Research 6New FORTEO® and EVISTA® Data to be Presented at Premiere Scientific Meeting for Bone and Mineral Research 7
(Date:3/28/2015)... The California-based leading wig brand UniWigs has prepared ... UniWigs during the Easter Holidays from today until April ... April Fools’ Day. , As the winter fades and ... Easter Festival, with religious origins to countries in Europe ... Christmas. The best wig provider, UniWigs, would like to ...
(Date:3/28/2015)... An article in Fortune on Monday, ... critical to organizations that deal with PCI (Payment Card ... data security, is worsening . Using numbers from ... major category out of the twelve measured improved, barring ... the craziness that has gone on in the retail ...
(Date:3/28/2015)... One in three young athletes who ... today at the American Orthopaedic Society for Sports Medicine’s ... long term success of surgery for patients aged 18 ... from 242 patients who underwent ACL reconstruction between 1993 ... FRACS, from North Sydney Orthopaedic and Sports Medicine Centre. ...
(Date:3/28/2015)... Las Vegas, NV (PRWEB) March 28, 2015 ... option for patients with Type V AC joint injuries, ... The study, presented today at the American Orthopaedic Society ... military personnel returned to duty faster when surgery was ... 24 patients, with 7 receiving surgical treatment and 17 ...
(Date:3/28/2015)... Portland, OR (PRWEB) March 28, 2015 ... in the media regarding recent changes and proposals around ... TV , current and former collegiate student-athletes across a ... experiences and reflect on common challenges. The special panel ... the country in sports ranging from football, track and ...
Breaking Medicine News(10 mins):Health News:UniWigs Is Sending Out Mysterious Gifts During the Easter Holidays 2Health News:Businesses Dealing With PCI Falling Short On Regular Vulnerability Scans and Pen Testing 2Health News:Businesses Dealing With PCI Falling Short On Regular Vulnerability Scans and Pen Testing 3Health News:Businesses Dealing With PCI Falling Short On Regular Vulnerability Scans and Pen Testing 4Health News:Young Athletes at Greater Risk for Re-Injury after ACL Surgery 2Health News:For Type V AC Joint Injuries, Early Surgery May Not Be the Best Approach 2Health News:SCI TV Panel of Former College Athletes Discusses Student Athlete Experience 2Health News:SCI TV Panel of Former College Athletes Discusses Student Athlete Experience 3
... on a new survey, sales of nicotine replacement have increased ... replacement therapy (NRT)// over the counter, without having to consult ... a good move. Make NRT more accessible and more people ... ,Researchers at the University of California, San Fransisco have analysed ...
... the standard treatment for viral warts to be the ... remain the treatment of choice for this common medical condition. ... will usually clear up eventually on their own. Anyhow, warts ... for people because those are on such visible parts of ...
... helped the Communicable Diseases Centre (CDC) at Atlanta identify a ... and Japan early this year. The new cholera pathogen, transmitted ... for scientists across the world. // ,The reason behind ... Indians made the discovery. “We received calls from the US ...
... , it was observed that carbohydrates that originate in ... from Harvard Medical School and Brigham and Women's Hospital ... body that causes inflammation. While the cause of arthritis ... light on the origin of the crippling disease. ...
... Columbia University researchers, people who suffer from the most ... to have a lower body mass index than their ... unknown origins, but doctors believe it may be neurodegenerative ... time that can interfere with a person's daily activities, ...
... Mifipriston, the new high-tech abortion drug being freely sold ... an era of do-it-yourself-abortions,// experts fear. Already, the sale ... claim, and even as the pharmaceutical concerns treat the ... to “the revolutionary approach to medical abortion”, the tribe ...
Cached Medicine News:Health News:Abortion made easy pill causes alarm in state 2
circuitGuard™ Products are available in filter or filter/HME styles., ,High quality air cushion anesthesia masks may be packaged with any circuitGuard™ product....
... Since 1991 Intersurgical ... breathing filters, heat and ... oxygen therapy products, hand-held ... range of accessories and ...
... Intersurgical Incorporated manufactures high ... and moisture exchangers, ventilator ... hand-held nebulizers and an ... and connectors for anesthesia ...
... Since 1991 Intersurgical Incorporated ... filters, heat and moisture ... therapy products, hand-held nebulizers ... of accessories and connectors ...
Medicine Products: