17β-Estradiol and natural progesterone for menopausal hormone therapy: REPLENISH phase 3 study design of a combination capsule and evidence review

Maturitas

Volumn 81, Issue 1, 2015, Pages 28-35

  Mirkin, Sebastian ^a   Amadio, Julia M ^a   Bernick, Brian A ^a   Pickar, James H ^b   Archer, David F ^c  

^a TherapeuticsMD   (United States)

^b Department of Medicine   (United States)

^c EASTERN VIRGINIA MEDICAL SCHOOL   (United States)

Author keywords

17 Estradiol; Bioidentical hormones; Menopause; Progesterone; Vasomotor symptoms

Indexed keywords

CONJUGATED ESTROGEN; ESTRADIOL; ESTROGEN; GELATIN; GESTAGEN; PROGESTERONE; TX 001HR; UNCLASSIFIED DRUG; DRUG COMBINATION; HORMONE; TX-001HR;

ARTICLE; BREAST; CARDIOVASCULAR EFFECT; DIABETES MELLITUS; DISEASE SEVERITY; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HORMONAL THERAPY; HUMAN; PHASE 3 CLINICAL TRIAL (TOPIC); POSTMENOPAUSE; VASOMOTOR DISORDER; VASOMOTOR SYMPTOM; ADULT; AGED; CLINICAL TRIAL; CONTROLLED STUDY; DRUG COMBINATION; HORMONE SUBSTITUTION; METHODOLOGY; MIDDLE AGED; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PROCEDURES; RANDOMIZED CONTROLLED TRIAL; UNITED STATES;

ARACHIS HYPOGAEA; EQUIDAE;

ADULT; AGED; DRUG COMBINATIONS; ESTRADIOL; ESTROGENS; FEMALE; HORMONE REPLACEMENT THERAPY; HORMONES; HUMANS; MIDDLE AGED; POSTMENOPAUSE; PROGESTERONE; PROGESTINS; RESEARCH DESIGN; UNITED STATES;

EID: 84928061679     PISSN: 03785122     EISSN: 18734111     Source Type: Journal    
DOI: 10.1016/j.maturitas.2015.02.266     Document Type: Review

References (59)

1. North American Menopause Society The 2012 hormone therapy position statement of: the North American Menopause Society Menopause 19 2012 257 271
2. National Institute of Health State-of-the-Science Panel Management of the menopause-related symptoms Ann Intern Med 142 2005 1003 1013
3. J.E. Rossouw, G.L. Anderson, and R.L. Prentice Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial JAMA 288 2002 321 333
4. A.R. Steinkellner, S.E. Denison, S.L. Eldridge, L.L. Lenzi, W. Chen, and S.J. Bowlin A decade of postmenopausal hormone therapy prescribing in the United States: long-term effects of the Women's Health Initiative Menopause 19 2012 616 621
5. B.L. Sprague, A. Trentham-Dietz, and K.A. Cronin A sustained decline in postmenopausal hormone use: results from the National Health and Nutrition Examination Survey, 1999-2010 Obstet Gynecol 120 2012 595 603
6. M. Stagnitti, and D. Lefkowitz Trends inhormone replacement therapy drug utilization and expenditures for adult women In The US civilian noninstitutionalized population, 2001-2008 2011 Agency for Healthcare Research and Quality 1 9
7. A.H. MacLennan, T.K. Gill, J.L. Broadbent, and A.W. Taylor Continuing decline in hormone therapy use: population trends over 17 years Climacteric 12 2009 122 130
8. Committee on Gynecologic Practice and the American Society for Reproductive Medicine Practice Committee Committee opinion no. 532: compounded bioidentical menopausal hormone therapy Obstet Gynecol 120 2012 411 415
9. L.A. Boothby, P.L. Doering, and S. Kipersztok Bioidentical hormone therapy: a review Menopause 11 2004 356 367
10. J. Pinkerton, and N. Santoro Compunded bioidentical hormone therapy: identifying use trends and knowledge gaps among US women Menopause 2015 [Epub ahead of print, February 17]
11. R.J. Santen, D.C. Allred, and S.P. Ardoin Postmenopausal hormone therapy: an Endocrine Society scientific statement J Clin Endocrinol Metab 95 2010 s1 s66
12. Writing Group for the PEPI Trial Effects of estrogen or estrogen/progestin regimens on heart disease risk factors in postmenopausal women. The postmenopausal estrogen/progestin interventions (PEPI) trial JAMA 273 1995 199 208
13. The Endocrine Society The Endocrine Society position statement on bioidentical hormones October 2006 〈https://www.endocrine.org/∼/media/endosociety/Files/Advocacy%20and%20Outreach/Position%20Statements/All/BH-Position-Statement-final-10-25-06-w-Header.pdf〉 (accessed on February 23, 2015)
14. FDA compounded menopausal hormone therapy questions and answers. US Food and Drug Administration website. 〈http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm183088.htm〉 (updated February 5, 2010; accessed February 23, 2015).
15. J.H. Pickar, C. Bon, J.M. Amadio, and B. Bernick Pharmacokinetics of the first combination 17ß-estradiol/progesterone capsule in clinical development for hormone therapy. Paper presented at: 24th Annual Meeting of the North American Menopause Society; October 9-12, 2013; Dallas, TX Menopause 20 2013 1346 1347
16. J.T. Hargrove, W.S. Maxson, and A.C. Wentz Absorption of oral progesterone is influenced by vehicle and particle size Am J Obstet Gynecol 161 1989 948 951
17. USDHHS US Food and Drug Administration Guidance for industry estrogen and estrogen/progestin drug products to treat vasomotor symptoms and vulvar and vaginal atrophy symptoms - recommendations for clinical evaluation 2003 USDHHS
18. European Medicines Agency Guideline on clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women 2005 European Medicines Agency London 13 October 2005
19. N. Ryan, and A. Rosner Quality of life and costs associated with micronized progesterone and medroxyprogesterone acetate in hormone replacement therapy for nonhysterectomized, postmenopausal women Clin Ther 23 2001 1099 1115
20. S. Mirkin, and D.F. Archer Effects of levonorgestrel, medroxyprogesterone acetate, norethindrone, progesterone, and 17beta-estradiol on thrombospondin-1 mRNA in Ishikawa cells Fertil Steril 82 2004 220 222
21. L.A. Fitzpatrick, C. Pace, and B. Wiita Comparison of regimens containing oral micronized progesterone or medroxyprogesterone acetate on quality of life in postmenopausal women: a cross-sectional survey J Womens Health Gend Based Med 9 2000 381 387
22. J. Montplaisir, J. Lorrain, R. Denesle, and D. Petit Sleep in menopause: differential effects of two forms of hormone replacement therapy Menopause 8 2001 10 16
23. L. Dennerstein, C. Spencer-Gardner, G. Gotts, J.B. Brown, M.A. Smith, and G.D. Burrows Progesterone and the premenstrual syndrome: a double blind crossover trial Br Med J (Clin Res Ed) 290 1985 1617 1621
24. E.W. Freeman, L. Weinstock, K. Rickels, S.J. Sondheimer, and C. Coutifaris A placebo-controlled study of effects of oral progesterone on performance and mood Br J Clin Pharmacol 33 1992 293 298
25. E.W. Freeman, K. Rickels, S.J. Sondheimer, and M. Polansky A double-blind trial of oral progesterone, alprazolam, and placebo in treatment of severe premenstrual syndrome JAMA 274 1995 51 57
26. C.E. Wood, T.B. Clarkson, and H. Chen Comparative effects of oral conjugated equine estrogens and micronized 17beta-estradiol on breast proliferation: a retrospective analysis Menopause 15 2008 890 898
27. G.L. Anderson, R.T. Chlebowski, and A.K. Aragaki Conjugated equine oestrogen and breast cancer incidence and mortality in postmenopausal women with hysterectomy: extended follow-up of the Women's Health Initiative randomised placebo-controlled trial Lancet Oncol 13 2012 476 486
28. E. Cordina-Duverger, T. Truong, and A. Anger Risk of breast cancer by type of menopausal hormone therapy: a case-control study among post-menopausal women in France PLoS ONE 8 2013 e78016
29. A. Fournier, F. Berrino, and F. Clavel-Chapelon Unequal risks for breast cancer associated with different hormone replacement therapies: results from the E3N cohort study Breast Cancer Res Treat 107 2008 103 111
30. A. Fournier, F. Berrino, E. Riboli, V. Avenel, and F. Clavel-Chapelon Breast cancer risk in relation to different types of hormone replacement therapy in the E3N-EPIC cohort Int J Cancer 114 2005 448 454
31. A. Fournier, A. Fabre, S. Mesrine, M.C. Boutron-Ruault, F. Berrino, and F. Clavel-Chapelon Use of different postmenopausal hormone therapies and risk of histology- and hormone receptor-defined invasive breast cancer J Clin Oncol 26 2008 1260 1268
32. D. Murkes, P.G. Lalitkumar, K. Leifland, E. Lundstrom, and G. Soderqvist Percutaneous estradiol/oral micronized progesterone has less-adverse effects and different gene regulations than oral conjugated equine estrogens/medroxyprogesterone acetate in the breasts of healthy women in vivo Gynecol Endocrinol 28 Suppl. 2 2012 12 15
33. D. Murkes, P. Conner, and K. Leifland Effects of percutaneous estradiol-oral progesterone versus oral conjugated equine estrogens-medroxyprogesterone acetate on breast cell proliferation and bcl-2 protein in healthy women Fertil Steril 95 2011 1188 1191
34. H. Kiran, A. Tok, M. Yuksel, D.C. Arikan, and H.C. Ekerbicer Estradiol plus drospirenone therapy increases mammographic breast density in perimenopausal women Eur J Obstet Gynecol Reprod Biol 159 2011 384 387
35. A.O. Mueck, H. Seeger, and D. Wallwiener Comparison of the proliferative effects of estradiol and conjugated equine estrogens on human breast cancer cells and impact of continuous combined progestogen addition Climacteric 6 2003 221 227
36. H. Seeger, D. Wallwiener, and A.O. Mueck The effect of progesterone and synthetic progestins on serum- and estradiol-stimulated proliferation of human breast cancer cells Horm Metab Res 35 2003 76 80
37. H.R. Franke, and I. Vermes Differential effects of progestogens on breast cancer cell lines Maturitas 46 Suppl. 1 2003 S55 S58
38. B. Xu, J. Kitawaki, and H. Koshiba Differential effects of progestogens, by type and regimen, on estrogen-metabolizing enzymes in human breast cancer cells Maturitas 56 2007 142 152
39. C. Otto, I. Fuchs, R. Vonk, and K.H. Fritzemeier Comparative analysis of the uterine and mammary gland effects of progesterone and medroxyprogesterone acetate Maturitas 65 2010 386 391
40. E.A. Kramer, H. Seeger, B. Kramer, D. Wallwiener, and A.O. Mueck The effects of progesterone, medroxyprogesterone acetate, and norethisterone on growth factor- and estradiol-treated human cancerous and noncancerous breast cells Menopause 12 2005 468 474
41. C.E. Wood, T.C. Register, C.J. Lees, H. Chen, S. Kimrey, and J.M. Cline Effects of estradiol with micronized progesterone or medroxyprogesterone acetate on risk markers for breast cancer in postmenopausal monkeys Breast Cancer Res Treat 101 2007 125 134
42. C.E. Wood, T.C. Register, and J.M. Cline Transcriptional profiles of progestogen effects in the postmenopausal breast Breast Cancer Res Treat 114 2009 233 242
43. X.D. Fu, M.S. Giretti, and L. Goglia Comparative actions of progesterone, medroxyprogesterone acetate, drospirenone and nestorone on breast cancer cell migration and invasion BMC Cancer 8 2008 166
44. S. Saarikoski, M. Yliskoski, and I. Penttila Sequential use of norethisterone and natural progesterone in pre-menopausal bleeding disorders Maturitas 12 1990 89 97
45. G. Casanova, S. Radavelli, F. Lhullier, and P.M. Spritzer Effects of nonoral estradiol-micronized progesterone or low-dose oral estradiol-drospirenone therapy on metabolic variables and markers of endothelial function in early postmenopause Fertil Steril 92 2009 605 612
46. G.M. Rosano, C.M. Webb, and S. Chierchia Natural progesterone, but not medroxyprogesterone acetate, enhances the beneficial effect of estrogen on exercise-induced myocardial ischemia in postmenopausal women J Am Coll Cardiol 36 2000 2154 2159
47. E.A. Booth, and B.R. Lucchesi Medroxyprogesterone acetate prevents the cardioprotective and anti-inflammatory effects of 17beta-estradiol in an in vivo model of myocardial ischemia and reperfusion Am J Physiol Heart Circ Physiol 293 2007 H1408 H1415
48. P.H. Cutini, A.E. Campelo, and V.L. Massheimer Differential regulation of endothelium behavior by progesterone and medroxyprogesterone acetate J Endocrinol 220 2014 179 193
49. E. Glusa, T. Graser, S. Wagner, and M. Oettel Mechanisms of relaxation of rat aorta in response to progesterone and synthetic progestins Maturitas 28 1997 181 191
50. M. Otsuki, H. Saito, and X. Xu Progesterone, but not medroxyprogesterone, inhibits vascular cell adhesion molecule-1 expression in human vascular endothelial cells Arterioscler Thromb Vasc Biol 21 2001 243 248
51. M. Canonico, A. Fournier, and L. Carcaillon Postmenopausal hormone therapy and risk of idiopathic venous thromboembolism: results from the E3N cohort study Arterioscler Thromb Vasc Biol 30 2010 340 345
52. M. Canonico, E. Oger, and G. Plu-Bureau Hormone therapy and venous thromboembolism among postmenopausal women: impact of the route of estrogen administration and progestogens: the ESTHER study Circulation 115 2007 840 845
53. B. de Lauzon-Guillain, A. Fournier, and A. Fabre Menopausal hormone therapy and new-onset diabetes in the French Etude Epidemiologique de Femmes de la Mutuelle Generale de l'Education Nationale (E3N) cohort Diabetologia 52 2009 2092 2100
54. H.N. Hodis, W.J. Mack, D. Shoupe, S.P. Azen, F.Z. Stanczyk, and J. Hwang-Levine Testing the menopausal hormone therapy timing hypothesis: the early versus late intervention trial with estradiol Circulation 130 Suppl. 2 2014
55. J.M. Kling, B.A. Lahr, K.R. Bailey, S.M. Harman, V.M. Miller, and S.L. Mulvagh Endothelial function in women of the Kronos Early Estrogen Prevention Study Climacteric 18 2015 1 11
56. N.L. Smith, M. Blondon, and K.L. Wiggins Lower risk of cardiovascular events in postmenopausal women taking oral estradiol compared with oral conjugated equine estrogens JAMA Intern Med 174 2014 25 31
57. M. Blondon, H.V. van, and K.L. Wiggins Differential associations of oral estradiol and conjugated equine estrogen with hemostatic biomarkers J Thromb Haemost 12 2014 879 886
58. M. Jayachandran, R. Mukherjee, and T. Steinkamp Differential effects of 17beta-estradiol, conjugated equine estrogen, and raloxifene on mRNA expression, aggregation, and secretion in platelets Am J Physiol Heart Circ Physiol 288 2005 H2355 H2362
59. T.N. Thomas, J.A. Rhodin, L. Clark, A. Garces, and M. Bryant A comparison of the anti-inflammatory activities of conjugated estrogens and 17-beta estradiol Inflamm Res 52 2003 452 460