SERM Education Project Reference List Abraham L, Pinkerton JV, Messig M, Ryan KA, Komm BS, Mirkin S. Menopause-specific quality of life across

Similar documents
The Tissue-Selective Estrogen Complex (TSEC): A Promising New Therapy for Menopausal Symptoms and Postmenopausal Osteoporosis

Tissue-selective estrogen complexes for postmenopausal women. BMS Satellite Symposium 14 nov 2015 A Pintiaux ULg

Selective estrogen receptor modulators in the treatment of osteoporosis: a review of the clinical evidence

Hormone therapy for menopausal vasomotor symptoms

POSITION PAPER FOR HEALTH CARE PROVIDERS Use of Pharmacologic Intervention for Breast Cancer Risk Reduction

VVA : new therapeutic options? BMS october 2017 A Pintiaux

Review Article The Tissue-Selective Estrogen Complex (Bazedoxifene/Conjugated Estrogens) for the Treatment of Menopause

Bazedoxifene/conjugated estrogens in combination with leuprolide for the treatment of endometriosis

Does raloxifene (Evista) prevent fractures in postmenopausal women with osteoporosis?

SERMS, Hormone Therapy and Calcitonin

Virtual Mentor Ethics Journal of the American Medical Association November 2005, Volume 7, Number 11

Prior disclosures past 3 years Consultant for Pfizer University of Virginia received Grants/research support from TherapeuticsMD

Raloxifene: A Selective Estrogen Receptor Modulator (SERM) with Multiple Target System Effects

Ms. Y. Outline. Updates of SERMs and Estrogen

Research. Breast cancer represents a major

WHI Estrogen--Progestin vs. Placebo (Women with intact uterus)

IJBCP International Journal of Basic & Clinical Pharmacology

Southern California Center for Sexual Health and Survivorship Medicine Inc, Newport Beach, CA 3

The NSABP Study of Tamoxifen and Raloxifene (STAR) trial

ASJ. Selective Estrogen Receptor Modulators. Asian Spine Journal. Introduction. Ki-Chan An. are acceptable and safety

BAZEDOXIFENO. NUEVO SERM EN EL MANEJO DE LA OSTEOPOROSIS

Vaginal atrophy is a common condition

Learning Objectives. Peri menopause. Menopause Overview. Recommendation grading categories

Outline. Estrogens and SERMS The forgotten few! How Does Estrogen Work in Bone? Its Complex!!! 6/14/2013

Marco Gambacciani President Italian Menopause Society Department of Obstetrics and Gynecology Pisa University Hospital Italy

Overdiagnosis in. breast cancers 12. chemoprevention trials. V. Sopik msc* and S.A. Narod md*

Therapy and Sexual Health

AusPharm CE Hormone therapy 23/09/10. Hormone therapy

Selective oestrogen receptor modulators in prevention of breast cancer: an updated meta-analysis of individual participant data

Endometrial effects of a tissue selective estrogen complex containing bazedoxifene/conjugated estrogens as a menopausal therapy

Benton Franklin County Medical Society 31st Annual CME Seminar

Women s Health: Managing Menopause. Jane S. Sillman, MD Assistant Professor of Medicine Harvard Medical School

Use of vaginal estrogen in Danish women: a nationwide cross-sectional study

MENOPAUSE. I have no disclosures 10/11/18 OBJECTIVES WHAT S NEW? WHAT S SAFE?

NIH Public Access Author Manuscript Curr Breast Cancer Rep. Author manuscript; available in PMC 2013 August 15.

Gynecologists are first-line providers for

Disclosures. REPLENISH Trial: Objective and Design. Background Use of compounded bioidentical hormone therapy (CBHT) has become highly prevalent

Columbia University Medical Center, New York, NY 2. Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA 3

Ospemifene: a safe treatment of vaginal atrophy

Breast Cancer Prevention

LET S START WITH (AND REMEMBER WE ARE TALKING ABOUT LOCAL E2) THERAPUTIC AGENTS: ARE THEY SAFE? Systemic HT/ET. Ospemifene. Local Estrogen Therapy

Evaluation of Systemic Effects of a Vaginal Estradiol Softgel Capsule Insert (TX-004HR) in Menopausal Women with Moderate to Severe Dyspareunia

MENOPAUSAL HORMONE THERAPY 2016

Effects of TX-001HR on Uterine Bleeding Rates in Menopausal Women with Vasomotor Symptoms

Menopausal Symptoms. Hormone Therapy Products Available in Canada for the Treatment of. Physician Desk Reference - 3rd Edition

How long should we treat primary osteoporosis?

Chemo-endocrine prevention of breast cancer

Effective Health Care Program

J Clin Oncol 29: by American Society of Clinical Oncology INTRODUCTION

Breast Cancer Prevention Studies. Key Points. Breast cancer prevention studies are clinical trials (research studies conducted with

Process of Aging. Manifestation of Estrogen and/or Androgen Loss: Symptoms Over Time. Estrogen Decrease and Its Impact on Sexual Functioning

HRT: Neue Kombinationen

Review Future possibilities in the prevention of breast cancer Breast cancer prevention trials Jack Cuzick

7 Potential risks of low-dose estrogen therapy have

Vaginal estrogen deficiency

New products and regimens (since 2003)

Breast-related effects of selective estrogen receptor modulators and tissue-selective estrogen complexes

WEIGHING UP THE RISKS OF HRT. Department of Endocrinology Chris Hani Baragwanath Academic Hospital

Serum estrogen level after hormone replacement therapy and body mass index in postmenopausal and bilaterally ovariectomized women

Chronic fatigue syndrome and retrovirus XMRV

PROSPECTIVE STUDIES HAVE

MANAGEMENT. Integrating Practice Management With Patient Care

QUERIES: to be answered by AUTHOR

The Practice Committee of the American Society for Reproductive Medicine,

Research Article The Treatment with Hormone Replacement Therapy and Phytoestrogens and The Evolution of Urogenital Symptoms in Postmenopausal Women

Post-menopausal hormone replacement therapy. Evan Klass, MD May 17, 2018

The Study of Tamoxifen and Raloxifene (STAR): Questions and Answers. Key Points

Postmenopausal osteoporosis is a systemic

HKCOG Guidelines. Guidelines for the Administration of Hormone Replacement Therapy. Number 2 revised January 2003

New Drug Evaluation: Delayed Release Duavee (conjugated estrogens/bazedoxifene)

9/26/2016. Disclosures. Genitourinary Syndrome of Menopause: Novel Term for Common Conditions. Objectives ISSWSH NAMS CONSENSUS CONFERENCE

North American Menopause Society (NAMS)

Can we improve the compliance to prevention treatment after a wrist fracture? Roy Kessous

In 2002, the U.S. Preventive Services Task Force. Review

HRT and bone health. Management of osteoporosis and controversial issues. Delfin A. Tan, MD

Tamoxifen For Breast Cancer Chemoprevention: Low Uptake by High-Risk Women After Evaluation of a Breast Lump

2004 OUTLOOK ON HORMONE REPLACEMENT THERAPY

BREAST CANCER RISK REDUCTION

Everyone knows 1/15/2018. Does Osteopenia Warrant Treatment? Osteoporosis Prevention: Is it Ever Warranted?

Osteoporosis is an asymptomatic skeletal disorder

Menopausal Symptoms The Who: Hot flashes are reported by as many as 75% of perimenopausal women in the U.S.

Raloxifene, the first selective estrogen

Hormones and Healthy Bones Joint Project of National Osteoporosis Foundation and Association of Reproductive Health Professionals

The 6 th Scientific Meeting of the Asia Pacific Menopause Federation

The Decrease in Breast-Cancer Incidence in 2003 in the United States

An Evidence-based Review of Clinical Trial Data

HKCOG Guidelines. Guidelines for the Administration of Hormone Replacement Therapy. Number 2 Revised November BENEFITS OF HRT

Breast Cancer and Bone Loss. One in seven women will develop breast cancer during a lifetime

Practical recommendations for hormone replacement therapy in the peri- and postmenopause

Menopausal hormone therapy currently has no evidence-based role for

Menopause management NICE Implementation

INTERACTIVE EFFECTS OF BAZEDOXIFENE ACETATE AND CONJUGATED EQUINE ESTROGENS ON THE BREAST AND REPRODUCTIVE TRACT OF POSTMENOPAUSAL MONKEYS

Menopause and HRT. John Smiddy and Alistair Ledsam

Hormone therapy (HT) is one ABSTRACT WOMEN S HEALTH. Current Status of Postmenopausal Hormone Therapy. Mary S. Beattie, MD

2017 Position Statement of Hormone Therapy of NAMS: overview SHELAGH LARSON, MS, RNC WHNP, NCMP ACCLAIM, JPS HEALTH NETWORK

OSTEOPOROSIS MANAGEMENT AND INVESTIGATION. David A. Hanley, MD, FRCPC

Management of Menopausal Symptoms

Original Article INTRODUCTION

Increased Risk of Breast Cancer: Screening and Prevention. Elizabeth Pritchard, MD 4/5/2017

Bazedoxifene and osteoporosis: systematic review

Transcription:

SERM Education Project Reference List Abraham L, Pinkerton JV, Messig M, Ryan KA, Komm BS, Mirkin S. Menopause-specific quality of life across varying menopausal populations with conjugated estrogens/bazedoxifene. Maturitas. 2014;78(3):212-218. Archer DF, Carr BR, Pinkerton JV, Taylor HS, Constantine GD. Effects of ospemifene on the female reproductive and urinary tracts: translation from preclinical models into clinical evidence. Menopause. 2015;22(7):786-796. Archer DF, Lewis V, Carr BR, Olivier S, Pickar JH. Bazedoxifene/conjugated estrogens (BZA/CE): incidence of uterine bleeding in postmenopausal women. Fertil Steril. 2009;92(3):1039-1044. Archer DF. The gynecologic effects of lasofoxifene, an estrogen agonist/antagonist, in postmenopausal women. Menopause. 2011;18(1):6-7. Bachmann G, Bobula J, Mirkin S. Effects of bazedoxifene/conjugated estrogens on quality of life in postmentopausal women with symptoms of vulvar/vaginal atrophy. Climacteric. 2010;13(2):132-140. Bachmann G, Gass M, Kagan R, Moffett A, Barcomb L, Symons J. Lasofoxifene (LASO), a next generation selective estrogen response modulator (SERM) improves dyspareunia in postmenopausal women with vaginal atrophy (VA) [abstract]. Menopause. 2005;12(2):238. Bachmann G, Gass M, Moffett A, Portman D, Symons J. Lasofoxifene improves symptoms associated with vaginal atrophy [abstract]. Menopause. 2004;11(6):669. Abstract P-63. Bachmann GA, Komi JO; Ospemifene Study Group. Ospemifene effectively treats vulvovaginal atrophy in postmenopausal women: results from a pivotal phase 3 study. Menopause. 2010;17(3):480-486. Barrett-Connor E, Grady D, Sashegyi A, et al; MORE Investigators (Multiple Outcomes of Raloxifene Evaluation). Raloxifene and cardiovascular events in osteoporotic postmenopausal women: four-year results from the MORE (Multiple Outcomes of Raloxifene Evaluation) randomized trial. JAMA. 2002;287(7):847-857. Barrett-Connor E, Mosca L, Collins P, et al; Raloxifene Use for The Heart (RUTH) Trial Investigators. Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. N Engl J Med. 2006;355(2):125-137. Berga SL. Profile of ospemifene in the breast. Reprod Sci. 2013;20(10):1130-1136. Bülbül NH, Ozden S, Dayicioglu V. Effects of hormone replacement therapy on mammographic findings. Arch Gynecol Obstet.2003;268(1):5-8. Burich R, Mehta N, Wurz G, et al. Ospemifene and 4-hydroxyospemifene effectively prevent and treat breast cancer in the MTag.Tg transgenic mouse model. Menopause. 2012;19(1):96-103. Carneiro AL, de Cassia de Maio Dardes R, Haidar MA. Estrogens plus raloxifene on endometrial safety and menopausal symptoms semisystematic review. Menopause. 2012;19(7):830-834. Conjugated estrogens/bazedoxifene (Duavee) for menopausal symptoms and prevention of osteoporosis. Med Lett Drugs Ther. 2014;56(1441):33-34. Constantine G, Graham S, Koltun WD, Kingsberg SA. Assessment of ospemifene or lubricants on clinical signs of VVA. J Sex Med. 2014;11(4):1033-1041. 1

Constantine G, Graham S, Portman DJ, Rosen RC, Kingsberg SA. Female sexual function improved with ospemifene in postmenopausal women with vulvar and vaginal atrophy: results of a randomized, placebo-controlled trial. Climacteric. 2015;18(2):226-232. Constantine GD, Goldstein SR, Archer DF. Endometrial safety of ospemifene: results of the phase 2/3 clinical development program. Menopause. 2015;22(1):36-43. Crandall CJ, Aragaki AK, Cauley JA, et al. Breast tenderness after initiation of conjugated equine estrogens and mammographic density change. Breast Cancer Res Treat. 2012;131(3):969-979. Crandall CJ, Aragaki AK, Cauley JA, et al. Breast tenderness and breast cancer risk in the estrogen plus progestin and estrogen-alone women's health initiative clinical trials. Breast Cancer Res Treat. 2012;132(1):275-285. Crandall CJ, Karlamangla A, Huang MH, Ursin G, Guan M, Greendale GA. Association of new-onset breast discomfort with an increase in mammographic density during hormone therapy. Arch Intern Med. 2006;166(15):1578-1584. Crew K. Addressing barriers to uptake of breast cancer chemoprevention for patients and providers. Am Soc Clin Oncol Educ Book. 2015;35:e50-e58. Cummings SR, Eckert S, Krueger KA, et al. The effect of raloxifene on risk of breast cancer in postmenopausal women: results from the MORE randomized trial. Multiple Outcomes of Raloxifene Evaluation. JAMA. 1999;281(23):2189-2197. Cummings SR, Ensrud K, Delmas PD, LaCroix AZ, et al; PEARL Study Investigators. Lasofoxifene in postmenopausal women with osteoporosis. N Engl J Med. 2010;362(8):686-696. Davidson NE, Kensler TW. MAPping the course of chemoprevention in breast cancer. N Engl J Med. 2011;364(25):2463-2464. Day R, Ganz PA, Costantino JP, Cronin WM, Wickerham DL, Fisher B. Health-related quality of life and tamoxifen in breast cancer prevention: a report from the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Clin Oncol. 1999;17(9):2659-2669. Day R; National Surgical Adjuvant Breast and Bowel Project P-1 study (NSABP-1). Quality of life and tamoxifen in a breast cancer prevention trial: a summary of findings from the NSABP P-1 study. National Surgical Adjuvant Breast and Bowel Project. Ann N Y Acad Sci. 2001;949:143-150. de Villiers TJ, Chines AA, Palacios S, et al. Safety and tolerability of bazedoxifene in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled phase 3 trial. Osteoporos Int. 2011;22(2):567-576. de Villiers TJ, Gass ML, Haines CJ, et al. Global consensus statement on menopausal hormone therapy. Climacteric. 2013;16(2):203-204. Delmas PD, Ensrud KE, Adachi JD, et al; Multiple Outcomes of Raloxifene Evaluation Investigators. Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis: four-year results from a randomized clinical trial. J Clin Endocrinol Metab. 2002;87(8):3609-3617. Eastell R, Adachi J, Hamer K, et al. The effects of raloxifene on incident vertebral fractures in postmenopausal women with osteoporosis: 4-year results from the MORE trial [abstract]. J Bone Miner Res. 2000;15(suppl 1):S229. Abstract F418. 2

Ensrud K, LaCroix A, Thompson JR, et al. Lasofoxifene and cardiovascular events in postmenopausal women with osteoporosis: Five-year results from the Postmenopausal Evaluation and Risk Reduction with Lasofoxifene (PEARL) trial. Circulation. 2010;122(17):1716-1724. Ettinger B, Black DM, Mitlak BH, et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. JAMA. 1999;282(7):637-645. Erratum in JAMA. 1999;282(22):2124. Ettinger B, Pressman A. Continuation of postmenopausal hormone replacement therapy in a large health maintenance organization: transdermal matrix patch versus oral estrogen therapy. Am J Manag Care. 1999;5(6):779-785. Fagerlin A, Dillard AJ, Smith DM, et al. Women s interest in taking tamoxifen and raloxifene for breast cancer prevention: response to a tailored decision aid. Breast Cancer Res Treat. 2011;127(3):681-688. Fagerlin A, Zikmund-Fisher BJ, et al. Women s decisions regarding tamoxifen for breast cancer prevention: responses to a tailored decision aid. Breast Cancer Res Treat. 2010;119(3):613-620. Fisher B, Costantino JAP, Wickerham DL, et al. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst. 1998;90(18):1371-1388. Fisher B, Costantino JP, Wickerham DL, et al. Tamoxifen for the prevention of breast cancer: current status of the National Surgical Adjuvant Breast and Bowel Project P-1 study. J Natl Cancer Inst. 2005;97(22):1652-1662. Gass M, Portman D, Bachmann G, Moffett A, Symons J. Clinical signs of vaginal atrophy are improved by the SERM lasofoxifene [abstract]. Menopause. 2004;11(6):670. Abstract P-68. Goldstein SR, Bachmann GA, Koninckx PR, Lin VH, Portman DJ, Ylikorkala O; Ospemifene Study Group. Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy. Climacteric. 2014;17(2):173-182. Goldstein SR, Kagan R. Incidence of bleeding or spotting with a conjugated estrogen/bazedoxifene compound compared to conjugated estrogen/progestogen to placebo [abstract]. Menopause. 2015;22(12):1384. Abstract P-31. Goldstein SR, Neven P, Cummings S, et al. Postmenopausal Evaluation and Risk Reduction With Lasofoxifene (PEARL) trial: 5-year gynecological outcomes. Menopause. 2011;18(1):17-22. Harvey JA, Pinkerton JV, Baracat EC, Shi H, Chines AA, Mirkin S. Breast density changes in a randomized controlled trial evaluating bazedoxifene/conjugated estrogens. Menopause. 2013;20(2):138-145. Harvey JA, Pinkerton JV, Baracat EC, Shi H, Mirkin S, Chines AA. Evaluation of changes in mammographic breast density associated with bazedoxifene/conjugated estrogens in postmenopausal women [abstract]. Endocr Rev. 2011;32(3). Abstract P1-79. Holli K, Valavaara R, Blanco G, et al. Safety and efficacy results of a randomized trial comparing adjuvant toremifene and tamoxifen in postmenopausal patients with node-positive breast cancer. Finnish Breast Cancer Group. J Clin Oncol. 2000;18(20):3487-3494. Kagan R, Williams RS, Pan K, Mirkin S, Pickar JH. A randomized, placebo- and active-controlled trial of bazedoxifene/conjugated estrogens for treatment of moderate to severe vulvar/vaginal atrophy in postmenopausal women. Menopause. 2010;17(2):281-289. 3

Kawate H, Takayanagi R. Efficacy and safety of bazedoxifene for postmenopausal osteoporosis. Clin Interv Aging. 2011;6:151-160. Kessel B, Nachtigall L, Plouffe L, Siddhanti S, Rosen A, Parsons A. Effect of raloxifene on sexual function in postmenopausal women. Climacteric. 2003;6(3):248-256. Kessel B, Nachtigall L, Plouffe L, Siddhanti S, Rosen A, Parsons A. Effect of raloxifene on sexual function in postmenopausal women. Climacteric. 2003;6(3):248-256. Komm BS, Thompson JR, Mirkin S. Cardiovascular safety of conjugated estrogens plus bazedoxifene: meta-analysis of the SMART trials. Climacteric. 2015;18(4):503-511. LaCroix AZ, Powles T, Osborne CK, et al; PEARL Investigators. Breast cancer incidence in the randomized PEARL trial of lasofoxifene in postmenopausal osteoporotic women. J Natl Cancer Inst. 2010;102(22):1706-1715. Langer RD, Manson JE, Allison MA. Have we come full circle or moved forward? The Women s Health Initiative 10 years on. Climacteric. 2012;15(3):206-212. Lindsay R, Gallagher JC, Kagan R, Pickar JH, Constantine G. Efficacy of tissue-selective estrogen complex (TSEC) of bazedoxifene/conjugated estrogens (BZA/CE) for osteoporosis prevention in at-risk postmenopausal women. Fertil Steril. 2009;92(3):1045-1052. Lobo RA, Pinkerton JV, Gass ML, et al. Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic parameters and overall safety profile. Fertil Steril. 2009;92(3):1025-1038. Loehberg CR, Jud SM, Haeberle L, et al. Breast cancer risk assessment in a mammography screening program and participation in the IBIS-II chemoprevention trial. Breast Cancer Res Treat. 2010;121(1):101-110. Love RR, Kurtycz DF, Dumesic DA, Laube DW, Yang Y. The effects of tamoxifen on the vaginal epithelium in postmenopausal women. J Womens Health Gend Based Med. 2000;9(5):559-563. Management of osteoporosis in postmenopausal women: 2010 position statement of The North American Menopause Society. Menopause. 2010;17(1):25-54; quiz 55-56. Martino S, Cauley JA, Barrett-Connor E, et al; CORE Investigators. Continuing outcomes relevant to Evista: breast cancer incidence in postmenopausal osteoporotic women in a randomized trial of raloxifene. J Natl Cancer Inst. 2004;96(23):1751-1761. McClung MR, Siris E, Cummings S, et al. Prevention of bone loss in postmenopausal women treated with lasofoxifene compared with raloxifene. Menopause. 2006;13(3):377-386. McNicholas MM, Heneghan JP, Milner MH, Tunney T, Hourihane JB, MacErlaine DP. Pain and increased mammographic density in women receiving hormone replacement therapy: a prospective study. AJR Am J Roentgenol. 1994;163(2):311-315. Mirkin S, Archer DF, Taylor HS, Pickar JH, Komm BS. Differential effects of menopausal therapies on the endometrium. Menopause. 2014;21(8):899-908. Mirkin S, Komm BS, Pan K, Chines AA. Effects of bazedoxifene/conjugated estrogens on endometrial safety and bone in postmenopausal women. Climacteric. 2013;16(3):338-346. Mirkin S, Pickar JH. Management of osteoporosis and menopausal symptoms: focus on bazedoxifene/conjugated estrogen combination. Int J Womens Health. 2013;5:465-475. 4

Mortimer JE, Boucher L, Baty J, Knapp DL, Ryan E, Rowland JH. Effect of tamoxifen on sexual functioning in patients with breast cancer. J Clin Oncol. 1999;17(5):1488-1492. Mosca L, Barrett-Connor E, Wenger NK, et al. Design and methods of the Raloxifene Use for The Heart (RUTH) study. Am J Cardiol. 2001;88(4):392-395. Mosca L, Grady D, Barrett-Connor E, et al. Effect of raloxifene on stroke and venous thromboembolism according to subgroups in postmenopausal women at increased risk of coronary heart disease. Stroke. 2009;40(1):147-155. O Connell MB. Prescription drug therapies for prevention and treatment of postmenopausal osteoporosis. J Manag Care Pharm. 2006;12(6 suppl A):S10-S19; quiz S26-28. Owens WL, Gallagher TJ, Kincheloe MJ, Ruetten VL. Implementation in a large health system of a program to identify women at high risk for breast cancer. J Oncol Pract. 2011;7(2):85-88. Parsons A, Merritt D, Rosen A, Heath H 3rd, Siddhanti S, Plouffe L Jr; Study Groups on the Effects of Raloxifene HCI With Low-Dose Premarin Vaginal Cream. Effect of raloxifene on the response to conjugated estrogen vaginal cream or nonhormonal moisturizers in postmenopausal vaginal atrophy. Obstet Gynecol. 2003;101(2):346-352. Pickar JH, Yeh IT, Bachmann G, Speroff L. Endometrial effects of a tissue selective estrogen complex (TSEC) containing bazedoxifene/conjugated estrogens as a menopausal therapy. Fertil Steril. 2009;92(3):1018-1024. Pinkerton JV, Abraham L, Bushmakin AG, et al. Evaluation of the efficacy and safety of bazedoxifene/conjugated estrogens for secondary outcomes including vasomotor symptoms in postmenopausal women by years since menopause in the Selective estrogens, Menopause and Response to Therapy (SMART) trials. J Womens Health (Larchmt). 2014;23(1):18-28. Pinkerton JV, Archer DF, Utian WH, et al. Bazedoxifene effects on the reproductive tract in postmenopausal women at risk for osteoporosis. Menopause. 2009;16(6):1102-1108. Pinkerton JV, Harvey JA, Lindsay R, Pan K, Chines AA, Mirkin S, et al; SMART-5 Investigators. Effects of bazedoxifene/conjugated estrogens on the endometrium and bone: a randomized trial. J Clin Endocrinol Metab. 2014;99(2):E189-E198. Pinkerton JV, Harvey JA, Pan K, et al. Breast effects of bazedoxifene-conjugated estrogens: a randomized controlled trial. Obstet Gynecol. 2013;121(5):959-968. Pinkerton JV, Komm BS, Mirkin S. Tissue selective estrogen complex combinations with bazedoxifene/conjugated estrogens as a model. Climacteric. 2013;16(6):618-628. Pinkerton JV, Pan K, Abraham L, et al. Sleep parameters and health-related quality of life with bazedoxifene/conjugated estrogens: a randomized trial. Menopause. 2014;21(3):252-259. Pinkerton JV, Shifren JL, La Valleur J, Rosen A, Roesinger M, Siddhanti S. Influence of raloxifene on the efficacy of an estradiol-releasing ring for treating vaginal atrophy in postmenopausal women. Menopause. 2003;10(1):45-52. Pinkerton JV, Stanczyk FZ. Clinical effects of selective estrogen receptor modulators on vulvar and vaginal atrophy. Menopause. 2014;21(3):309-319. Pinkerton JV, Utian WH, Constantine GD, Olivier S, Pickar JH. Relief of vasomotor symptoms with the tissue-selective estrogen complex containing bazedoxifene/conjugated estrogens: a randomized, controlled trial. Menopause. 2009;16(6):1116-1124. Erratum in: Menopause. 2015;22(2):245. 5

Plouffe L Jr. Selective estrogen receptor modulators (SERMs) in clinical practice. J Soc Gynecol Investig. 2000;7(1 suppl):s38-s46. Portman D, Palacios S, Nappi RE, Mueck AO. Ospemifene, a non-oestrogen selective oestrogen receptor modulator for the treatment of vaginal dryness associated with postmenopausal vulvar and vaginal atrophy: a randomised, placebo-controlled, phase III trial. Maturitas. 2014;78(2):91-98. Portman DJ, Bachmann GA, Simon JA; Ospemifene Study Group. Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause. 2013;20(6):623-630. Portman DJ, Moffett AH, Bachman GA, West C, Symons J. Lasofoxifene, a selective estrogen receptor modulator, improves objective measures of vaginal atrophy. Obstet Gynecol. 2004;103:25S-26S. Qu Q, Zheng H, Dahllund J, et al. Selective estrogenic effects of a novel triphenylethylene compound, FC1271a, on bone, cholesterol level, and reproductive tissues in intact and ovariectomized rats. Endocrinology. 2000;141(2):809-820. Silverman SL, Chines AA, Kendler DL, et al; Bazedoxifene Study Group. Sustained efficacy and safety of bazedoxifene in preventing fractures in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled study. Osteoporos Int. 2012;23(1):351-363. Silverman SL, Christiansen C, Genant HK, et al. Efficacy of bazedoxifene in reducing new vertebral fracture risk in postmenopausal women with osteoporosis: results from a 3-year, randomized, placebo-, and active-controlled clinical trial. J Bone Miner Res. 2008;23(12):1923-1934. Simon J, Portman D, Mabey RG Jr; Ospemifene Study Group. Long-term safety of ospemifene (52-week extension) in the treatment of vulvar and vaginal atrophy in hysterectomized postmenopausal women. Maturitas. 2014;77(3):274-281. Simon JA, Lin VH, Radovich C, Bachmann GA; Ospemifene Study Group. One-year long-term safety extension study of ospemifene for the treatment of vulvar and vaginal atrophy in postmenopausal women with a uterus. Menopause. 2013;20(4):418-427. Siris E, Adachi JD, Lu Y, et al. Effects of raloxifene on fracture severity in postmenopausal women with osteoporosis: results from the MORE study. Multiple Outcomes of Raloxifene Evaluation. Osteoporos Int. 2002;13(11):907-913. Smith MR, Morton RA, Barnette KG, et al. Toremifene to reduce fracture risk in men receiving androgen deprivation therapy for prostate cancer. J Urol. 2010;184(4):1316-1321. Steel SA, Albertazzi P, Howarth EM, Purdie DW. Factors affecting long-term adherence to hormone replacement therapy after screening for osteoporosis. Climacteric. 2003;6(2):96-103. Stevenson JC, Chines A, Pan K, Ryan KA, Mirkin S. A pooled analysis of the effects of conjugated estrogens/bazedoxifene on lipid parameters in postmenopausal women from the Selective estrogens, Menopause, and Response to Therapy (SMART) trials. J Clin Endocrinol Metab. 2015;100(6):2329-2338. Stovall DW, Utian WH, Gass ML, et al. The effects of combined raloxifene and oral estrogen on vasomotor symptoms and endometrial safety. Menopause. 2007;14(3 pt 1):510-517. Stuenkel CA, Gass ML, Manson JE, et al. A decade after the Women s Health Initiative the experts do agree. Menopause. 2012;19(8):846-847. Taras TL, Wurz GT, DeGregorio MW. In vitro and in vivo biologic effects of ospemifene (FC-1271a) in breast cancer. J Steroid Biochem Mol Biol. 2001;77(4-5):271-279. 6

Taras TL, Wurz GT, DeGregorio MW. In vitro and in vivo biologic effects of ospemifene (FC-1271a) in breast cancer. J Steroid Biochem Mol Biol. 2001;77(4-5):271-279. Utian W, Yu H, Bobula J, Mirkin S, Olivier S, Pickar JH. Bazedoxifene/conjugated estrogens and quality of life in postmenopausal women. Maturitas. 2009;63(4):329-335. Visvanathan K, Hurley P, Bantug E, et al. Use of pharmacologic interventions for breast cancer risk reduction: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2013;31(23):2942-2962. Vogel CL, Johnston MA, Capers C, Braccia D. Toremifene for breast cancer: a review of 20 years of data. Clin Breast Cancer. 2014;14(1):1-9. Vogel VG, Costantino JP, Wickerham DL, et al; National Surgical Adjuvant Breast and Bowel Project (NSABP). Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial. JAMA. 2006;295(23):2727-2741. Erratum in: JAMA. 2006;296(24):2926. JAMA. 2007;298(9):973. Vogel VG, Costantino JP, Wickerham DL, et al; National Surgical Adjuvant Breast and Bowel Project. Update of the National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene (STAR) P-2 Trial: Preventing breast cancer. Cancer Prev Res (Phila). 2010;3(6):696-706. 7