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

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209 trllUCeJ I nal: ELI I h: Early Versus Late Intervention Trial With Estruadiol ClinicalTrials.gov Ln s s A - f..*d . U.3, Mse.hbtrtuse..d M. "b ~d 9I ume Sashb Listngsi ! gelsresa I 1H f i A d Purpose ELITE: Early Versus Late Intervention Trial With Estradiol This study is currently recruiting patients. Verified by Natiosal Institute on Aging (NIA) February 207 Sponsored by: National Institute on Ating (NIAl Information provided by: National Institute on Aging (NIA) ClinicalTrials.gov Identifier: NCTOOI 14517 aW fmeanr The purpose of tiis study is to examine the effects of 17B-estradiol (estrogen) on the progression of early atherosclerosis in postmenopausal women. lConditlon D intervention IPhase Atherosclerosis Drug: 1 7B-estradiol PihaseRi MedlinePlsj! related topics: Vascular Disses Oneticsllomse Relbence related topics: Yasclariseases Ab Sout Study Type: Interventional Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study Official Title: Biologic Response of Menopausal Wmrnen to 1 7Bt-Eradio Further study details as provided by National Institute on Aging (NIA): Primary Outcomes: rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT) Secondary Outcomes: neurocognitive function Expected Total Enmollment: 504 Study start: July 2004; Expected completion: June 2009 The primary hypothesis to be tested is that 17B-estradiol (estrogen) will reduce the progression of early atherosclerosis if initiated soon after menopause when the vascular endothelium (lining of blood vessels) is relatively healthy versus later when the endothelium has lost its responsiveness to estrogen. Ultrasonography will be used to measure the rate of change in the thickness of the carotid artery. A total of 504 postmenopausal women will be randomized according to their number of years since menopause, less than 6 years or 10 years or more, to receive either oral I 7B-estradiol I mg daily or a placebo. Women with a uterus will also use vaginal progesterone gel 4% (or a placebo gel) the last ten days of each month. The vaginal progesterone will be distributed in a double-blind fashion along with the
210 ,lmcCII na: CLI I tr: tarty versus Late lntervention Trial With Estradiol Eligibility randomized treatment so that only women exposed to active treatment will receive active progesterone. Participants will receive ultrasonography at baseline and every 6 months throughout the 2 to 5 years (average 3 years) of randomized treatment. Genders Eligible for Study: Female Accepts Healthy Volunteers Criteria Inclusion Criteria: * Women with a serum estradiol level 25 pg/ml or less * No period for 6 months or more * Postmenopausal less than 6 years, OR IO years or longer Exclusion Criteria: * Clinical signs, symptoms, or personal history of cardiovascular disease * Women who have had a hysterectomy only and no oophorectomy (since time from menopause cannot be determined) * Diabetes mellitus or fasting serum glucose 140 mg/dL or greater * Uncontrolled hypertension (diastolic blood pressure 110 mmHg or greater) * Thyroid disease (untreated) * Serum creatinine greater than 2.0 mg/dL * Plasma triglyceride levels greater than 500 mg/dL * Life threatening disease with prognosis less than 5 years * Cirrhosis or liver disease * History of deep vein thrombosis or pulmonary embolism * History of breast cancer * Current hormone replacement therapy (HRT) Location and Contact Information Please refer to this study by ClinicalTrials.gov identifier NCTOOI 14517 United States, California Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine. Los Angeles, Califomia, 90033, United States; Recruiting Howard N. Hodis, MD 866-240-1489 arulusedu Study chairs or principal investigators Howard N. Hodis, MD, Principal Investigator, University of Southern Califomia, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine More Information htf -- e liir, ttic I.Av -/,k/.hn,.,.,InwlTAl 1 IA I d In~nrrA tf7-l1A7
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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
Page 161 and 162: 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 209 and 210: 206 HORMONE THERAPY USE AND RISK OF
Page 211: 208 HORMONE THERAPY USE AND RISK OF
Page 215 and 216: 212 ,mucmai rimi &ronos farty bstro
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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