The FDA has allowed Repros Therapeutics to run a single, low-dose study of its uterine fibroid and endometriosis drug Proellex under a partial clinical hold. In the new study, escalating doses (1, 3, 6, 9 and 12mg) of the drug will be compared with placebo. No higher doses will be studied until Repros is confident that it is safe to proceed to the next dose and has reported safety findings to the FDA, the company said. Repros expects to enroll 60 subjects in the low-dose study. The move follows a request by Repros last April to lift the the full clinical hold placed by the FDA last year.
See http://fdanews.com/newsletter/article?issueId=13849&articleId=128538
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DERAILED Memoirs of a Botched Hysterectomy - Hysterectomy to Remove Fibroids and Cyst - Really was ENDOMETRIOSIS! How does an outwardly healthy 47-year old woman's "routine hysterectomy" become an 18-day ordeal spanning 2 hospitals, 4 surgeries, and $400,000 in medical bills?
DERAILED is a true story - one woman's terrifying journey through a seemingly endless comedy of errors, miss-diagnosis, and near-death experiences. The reader will find themselves immersed in the constant stream of turmoil experienced by the unsuspecting patient; including cover ups, good doctors protecting bad doctors, and hospitals pitted against the other. Who is she? She is any woman, anywhere and everywhere.
Written by a woman unwilling to give up, the author's light hearted approach will endear you to the class and dignity she portrays; including scores of useful medical facts based upon subsequent research in the areas of fibroids, cysts, endometriosis, blood transfusions, drugs, blood clots, bypass implants, and more - all things she endured as a result of a so called "routine hysterectomy."
Editor's note: Coverage of endometriosis, with some food for thought writing and media criticism thrown in. Sponsoring: DERAILED Memoirs of a Botched Hysterectomy - Hysterectomy for Fibroids and Cyst Really was ENDOMETRIOSIS!, this is an important book and the lessons learned through these pages could very well save women's lives - including more than 38 resources. Get the facts about ENDOMETRIOSIS!
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Friday, September 24, 2010
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