Bioidentical Hormones - U.S. Senate Special Committee on Aging

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211 k1Wca1 Infa: bLit: ,1 tatry VeSts Late Intervention Trial With Estradiol USC Athbmclrosi -e-seh Unit ELITE idnI Study ID Numbers: AG0025; ROIAG024154 Last Updated: February 15, 2D07 Record first receivedt June 15, 2005 CinicalTrials.gov Identifier: XCT00114L7 Health Authority: United States: Federal Government Chinkaflrnals.gov processed this record on 2007-03.29 U.S. Nilional DeLarnn.,t of HtditN j CMnnmq S I onal Issutaof HelMh f of Hertth A HuwnpnSrvc USA&Qy CMJ. Pyi, Apzggsigift, Fredom of htfbmmttio g Act i A It 1,71-A-IM
212 ,mucmai rimi &ronos farty bstrogen krevention Study (KEEPS) CfinicalTrials.gov in, _ Hpmne Scorch I , e j WhaN Purpose Kronos Early Estrogen Prevention Study (KEEPS) This study is currently recruiting patients. Verified by Krnor Lmgffevity Kearch IfitsIte May 2006 Sponsors and Collaborators: Kronos Longevity Research Institute Albert Einstein College of Medicine Brigham and Women's Hospital Columbia Presbyterian Medical Center Mayo Clinic University of California, San Francisco University of Utah University of Washington Yale University Information provided by: Kronos Longevity Research Institute CllnicalTrialshgov Identifier. NCT00154180 I ra MkSIWC* The study will examine the effects of estrogen and progesterone on the development of atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the menopausal transition Condttion Interventton Phan Menopause Drug: Conjugated equine estrogens 0.45 mg/day Arteriosclerosis Drug: Transdermal estradiol. 50 mcg/day Drug: Micronized progesterone, 200 mg/day x 12 d/month Me4linePlus related topics: YaseulutDieasesw Qenetielm oe Reference related topics: Vascular Diseags Study Type: Interventional Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficscy Study Official Title: Effects of Estrogen Replacement on Atherosclerosis Progression in Recently Menopausal Women Further study details as provided by Kronos Longevity Research Institute: Prinary Outcomes: Rate of change of carotid intimal medial thickness by ultrasound Secondary Outcomes: Change in coronaty calcium score by X-ray tomography; Plasma lipid profiles; Blood clotting factors, Serum inflammatory factors; Hormone levels; Cognitive and Affective scores on standard psychometric tests; Quality of life Expected Total Enrollment: 720 .-11.._._.I;.. _1:_:__11_. -,.0--W.h.A Y I Al I QfAI74-AA '"drcui Annnnn~f7
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S. HRG. 110-129 Bioidentica
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CONTENTS Page Opening Statement of
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2 The sale of bioidentical hormone
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4 ever, as Dr. Wartofsky points out
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6 with every stage of the disease:
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8 I am pleased to appear before thi
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10 When the trials began, many rese
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Women who began treatment more than
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14 One small trial using oral estra
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16 FDA is aware that a growing numb
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18 DEPARTMENT OF HEALTH & HUMAN SER
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20 safety and efficacy. However, as
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22 adulteration and misbranding pro
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24 The 2002 CPG reflects FDA's curr
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26 Equally concerning are claims by
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28 concerned about the use and mark
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30 Part I: Materials and Partnershi
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32 drugs, when the compounding of t
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34 Our staff identified 34 Web site
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1. Introduction 36 Chairman Kohl, R
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diet and fitness products. 5 For ex
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include "natural" progesterone crea
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42 unique to the computer age, such
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computer users to spam(ftuce.0ov -
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46 accuracy of advertising for heal
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48 Now, you have identified in your
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50 claim." Therefore, since the ter
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52 Such quality control problems ha
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54 Statement Before the U.S. <stron
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in the U.S., whereas WHI participan
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58 between science and hearsay and
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60 How can we determine whether bio
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62 doctors-are not getting the obje
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64 27. Writing Group for the PEPI T
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66 Dr. MANSON. Well, I think that m
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68 Statement of Leonard Wartofsky,
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70 in the WHI. In fact, no study as
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In summary, the Endocrine Society i
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74 The FDA also regulates aspects o
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Statement of Loyd V. Allen, Jr., Ph
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82 Senator SMITH. Dr. Allen, as I h
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84 Now, when you are talking about
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86 The only thing the WHI proved wa
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88 Testimony Of T.S. Wiley before t
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Confusion and Media Hype 90 Instead
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92 see a doctor tell a diabetic nea
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94 the only compelling reason to ta
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96 identical hormones synthesized f
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98 The world as we know it, from ba
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100 thereby experienced long period
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102 Bio-identical progesterone repl
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104 had reached optimum theoretical
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106 and the patient can be can reas
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108 Estradiol and Analytical Resear
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110 A controlled systematic pilot c
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112 of set doses. The Wiley Protoco
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114 I'd advocate for either Accredi
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116 D.C., and established a goal to
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118 If this legislation passes, fed
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first and second finger on the barr
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122 These products that have been s
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124 Bcl-2, survivin and variant CD4
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126 These are experiments by other
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128 cerebro-cellular inflammation c
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130 Years # women *1>0.5 8 *1+ 9 *2
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*Breast cancer 132 -57 y.o. recurre
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134 *Labor intense for patient and
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136 Senator SMITH. Thank you very m
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138 makes these hormones uniquely s
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140 tomize the Wiley Protocol by ra
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142 "natural," because all lead to
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144 maceutical commerce, often with
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146 WHITE PAPER #1 DID YOU KNOW THA
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148 WHITE PAPER #2 Pharmacy Compoun
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150 bleeding of the bowel, locate t
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152 compounding standards can be en
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154 I. The FDA's definition of a "N
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156 ORIIGINAL CONTrMIBTION JANMA-EX
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Initially, the design allowed women
Page 163 and 164: ards analyses," stratified by clini
Page 165 and 166: year). These 'drop-in" rates were a
Page 167 and 168: years of prior use, 11 vs 2; HR, 4.
Page 169 and 170: trogen plus progestin exposure. Clo
Page 171 and 172: 168 RISKS AND BENEFITS OF ESTROGEN
Page 173 and 174: EFFECTS OF POSTMENOPAUSAL ESTIROGEN
Page 175 and 176: EFFECTS OF POSTMENOPAUSAL ESTROGEN
Page 179 and 180: pEyECTS OF POSTMENOPAUSAL ESTROGEN
Page 185 and 186: 10000 isoor i I ea '° a wan 20-24
Page 187 and 188: ~SDt~rpa g~2~Q ~ !~fm~. b~e ~ ng jh
Page 189 and 190: Is associated with an Increased ris
Page 191 and 192: 188 Postmenopausal hormone therapy
Page 193 and 194: group (P= 04001), and In this subgr
Page 195 and 196: Treatmnent recommendations Based on
Page 197 and 198: 21.Grodsteln F. Manson JE, Colditz
Page 199 and 200: _ ORWIGNAL CONTIuBUTION 196 Postmen
Page 201 and 202: showed no striking differences in H
Page 203 and 204: (214 cases; P for trend=.72): howev
Page 205 and 206: 202 HORMONE THERAPY USE AND RISK OF
Page 207 and 208: mal studies, and laboratory studies
Page 213: 210 ,lmcCII na: CLI I tr: tarty ver
Page 217 and 218: 214 LntIucwu miau: rronos nary estr
Page 219 and 220: XVI. PNharmacy Licensure Requiremen
Page 221 and 222: XVI. Pharmacy Licensure Requirement
Page 223 and 224: 220 Roster of Board of Pharmacy Ece
Page 225 and 226: 050. 0l7404405400 Al-h. PeVbU 03283
Page 227 and 228: Conclusions * Age is a powerful ris
Page 229 and 230: Women's Health Initiative Trials of
Page 231 and 232: Hormone Therapy after WHI * Change
Page 233 and 234: Statement of the American Pharmacis
Page 235 and 236: 232 APhA Statement to the S
Page 243 and 244: 240 Written Testimony of Steven F.
Page 245 and 246: 242 STATEMENT OF DAVID G. ADAMS On
Page 247 and 248: 244 Report on State Laws and Regula
Page 249 and 250: 246 Only one state, Utah, requires
Page 251: 248 5. Compounding Copies of FDA-Ap
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Bioidentical Hormones - U.S. Senate Special Committee on Aging

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