HRA Pharma Commences US Phase III Trial of Second-Generation Emergency Contraceptive.PARIS Paris, in Greek mythology Paris or Alexander, in Greek mythology, son of Priam and Hecuba and brother of Hector. Because it was prophesied that he would cause the destruction of Troy, Paris was abandoned on Mt. -- HRA HRA Health Reimbursement Arrangement HRA Health Risk Assessment HRA Housing and Redevelopment Authority HRA Human Resources Administration HRA Health Reimbursement Account HRA Housing Revenue Account Pharma today announced the start of a pivotal multi-centre Phase III study evaluating its proprietary second-generation emergency contraceptive - Ella([R]). The study will be conducted in sixteen clinics affiliated with Planned Parenthood Planned Parenthood A service mark used for an organization that provides family planning services. Federation of America (PPFA PPFA Planned Parenthood Federation of America, Inc. (since 1916; New York City, NY, USA) PPFA Professional Picture Framers Association PPFA Page Printer Formatting Aid (IBM) ) in seven different US states. Dr. Andre Ulmann, 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. of HRA Pharma: "Every year millions of women find themselves in need of emergency contraception Emergency Contraception Definition Emergency contraception or emergency birth control uses either emergency contraceptive pills (ECPs) or a Copper-T intrauterine device (IUD) to help prevent pregnancy following unprotected vaginal intercourse. .This is therefore an important trial of a contraceptive that could offer significant benefits for many women worldwide. The drug holds a great deal of promise and may present some real advantages for emergency contraception." The purpose of the open-label investigation is to confirm the safety and efficacy of Ella([R]) (otherwise known as CDB-2914) as an emergency contraceptive. Over one thousand women will volunteer to participate in the trial. Women over 18 years old who request emergency contraception from one of the participating sites within 120 hours (5 days) of unprotected sexual intercourse or a contraceptive failure may be eligible for the study. HRA Pharma expects to complete the study by the end of 2007 and, after FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval, to launch Ella([R]) in the U.S. by 2009. "CDB-2914 is the first compound ever to have been developed expressly with emergency contraception in mind" said Vanessa Cullins, PPFA VP for Medical Affairs. "Planned Parenthood welcomes innovations that expand contraceptive choices and increase family planning options". Results of a successful double-blind comparison of CDB-2914 versus levonorgestrel levonorgestrel /le·vo·nor·ges·trel/ (-nor-jes´trel) the levorotatory form of norgestrel; used as an oral or subdermal contraceptive. le·vo·nor·ges·trel n. for emergency contraception were published by Creinin et al in the November 2006 issue of Obstetrics & Gynecology. Full details of this clinical study and directions for potential volunteers can be found at www.clinicaltrials.gov. Reference: Creinin et al, 'Progesterone receptor modulator Modulator Any device or circuit by means of which a desired signal is impressed upon a higher-frequency periodic wave known as a carrier. The process is called modulation. The modulator may vary the amplitude, frequency, or phase of the carrier. for emergency contraception', Obstetrics and Gynecology obstetrics and gynecology Medical and surgical specialty concerned with the management of pregnancy and childbirth and with the health of the female reproductive system. , Vol. 108, No 5, November 2006 About HRA Pharma HRA Pharma is a private pharmaceutical company based in Paris, France. The Company creates innovative medicines and products for women's and reproductive health, hormonal cancer treatments and cell-based therapies. HRA Pharma has a proven track record of developing and commercializing products in its key therapeutic areas. Its first product, NorLevo([R]) emergency contraception, launched in France in 1999, is now available in over 50 countries. The Company's other products include Gymiso([R]), a prostaglandin for use in obstetrics and gynecology, Cicatridine([R]) which promotes vaginal healing, Mona-Lisa([R]), a copper contraceptive IUD IUD Definition An IUD is an intrauterine device made of plastic and/or copper that is inserted into the womb (uterus) by way of the vaginal canal. One type releases a hormone (progesterone), and is replaced each year. (intrauterine device), and Lysodren([R]), for the treatment of adrenal adrenal /ad·re·nal/ (ah-dre´n'l) 1. paranephric. 2. adrenal gland. 3. pertaining to an adrenal gland. ad·re·nal adj. 1. cortical carcinoma. Three of HRA's products have received national awards for their usefulness to patients. In addition, HRA also has distribution rights in France for eight products from Orion Pharma's (Finland) portfolio in the fields of oncology, pneumology, gynecology and neurology. As well as its marketed products, the Company has an internal pipeline of new products in development in women's and reproductive health and hormonal cancer therapy. HRA is also developing cell medicines for the treatment of anal and urinary incontinence, and ocular myopathy through its alliance with Celogos, a biotech company also based in France. HRA Pharma was founded by a team of medical specialists who genuinely care about global healthcare. The Company has invested significant effort in establishing strong links with international NGOs and local authorities, which enable it to help meet the needs of women who might otherwise be unable to afford appropriate treatments/products. For further information please visit the website at www.hra-pharma.com About PPFA Planned Parenthood Federation of America is the nation's leading sexual and reproductive health care advocate and provider. We believe that everyone has the right to choose when or whether to have a child, and that every child should be wanted and loved. Planned Parenthood affiliates operate more than 860 health centers nationwide, providing medical services and sexuality education for millions of women, men, and teenagers each year. We also work with allies worldwide to ensure that all women and men have the right and the means to meet their sexual and reproductive health care needs. For further information, visit www.plannedparenthood.org |
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