New hormonal therapies and regimens in the postmenopause: routes of administration and timing of initiation

References

• Rossouw J E, Anderson G L, Prentice R L, , Writing Group for the Women's Health Initiative investigators, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA 2002; 288: 321–333
   PubMed Web of Science ®Google Scholar
• The WHI Steering Committee. Effect of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA 2004; 291: 1701–1712
   PubMed Web of Science ®Google Scholar
• Beral V. Million Women Study Collaborators. Breast cancer and hormone-replacement therapy in the Million Women Study. Lancet 2003; 362: 419–427
   PubMed Web of Science ®Google Scholar
• Phillips L S, Langer R D. Postmenopausal hormone therapy: critical reappraisal and a unified hypothesis. Fertil Steril 2005; 83: 558–566
   PubMed Web of Science ®Google Scholar
• Clark J H. A critique of Women's Health Initiative Studies (2002–2006). Nucl Recept Signal 2006; 4: e-23
   Google Scholar
• Pines A, Sturdee D W, Birkhäuser M H, , on behalf of the Board of the International Menopause Society, et al. IMS Updated Recommendations on postmenopausal hormone therapy. Climacteric 2007; 10: 181–194
   PubMed Web of Science ®Google Scholar
• De Lignieres B, Basdevant A, Thomas G, et al. Biological effects of estradiol-17 beta in postmenopausal women: oral versus percutaneous administration. J Clin Endocrinol Metab 1986; 62: 536–541
   PubMed Web of Science ®Google Scholar
• Scarabin P-Y, Oger E, Plu-Bureau G, et al. Differential association of oral and transdermal oestrogen-replacement therapy with venous thromboembolism risk. Lancet 2003; 362: 428–432
   PubMed Web of Science ®Google Scholar
• Canonico M, Oger E, Plu-Bureau G, et al. Hormone therapy and venous thromboembolism among postmenopausal women: impact of the route of estrogen administration and progestogens: the ESTHER study. Circulation 2007; 115: 840–845
   PubMed Web of Science ®Google Scholar
• Fournier A, Berrino F, Riboli E, et al. Breast cancer risk in relation to different types of hormone replacement therapy in the E3N-EPIC cohort. Int J Cancer 2005; 114: 448–454
   PubMed Web of Science ®Google Scholar
• Fournier A, Berrino F, Clave-Chapelon F. Unequal risks for breast cancer associated with different hormone replacement therapies: results from the E3N cohort study. Breast Cancer Res Treat Feb 27, 2007, [Epub ahead of print]
   PubMedGoogle Scholar
• Cicinelli E, de Ziegler D. Transvaginal progesterone: evidence for a new functional ‘portal system’ flowing from the vagina to the uterus. Hum Reprod Update 1999; 5: 365–372
   PubMed Web of Science ®Google Scholar
• Cicinelli E, de Ziegler D, Bulletti C, et al. Direct transport of progesterone from vagina to uterus. Obstet Gynecol 2000; 95: 403–406
   PubMed Web of Science ®Google Scholar
• Sitruk-Ware R. Delivery options for contraceptives. Drug Discov Today 2005; 10: 977–985
   PubMed Web of Science ®Google Scholar
• Sitruk-Ware R. Hormonal replacement therapy. A review. Rev Endocrine Metab Disorders 2002; 3: 243–256
   PubMedGoogle Scholar
• Kuhl H. Pharmacology of estrogen and progestogens: influence of different routes of administration. Climacteric 2005; 8(Suppl 1)3–63
   PubMed Web of Science ®Google Scholar
• Samsioe G. Transdermal hormone therapy: gels and patches. Climacteric 2004; 7: 347–356
   PubMed Web of Science ®Google Scholar
• Mishell D R, Jr, Moore D E, Roy S, et al. Clinical performance and endocrine profiles with contraceptive vaginal rings containing a combination of estradiol and d-norgestrel. Am J Obstet Gynecol 1978; 130: 55–62
   PubMed Web of Science ®Google Scholar
• Nash H A, Sanchez-Alvarez F, Mishell D R, Jr, et al. Estradiol-delivering vaginal rings for hormone replacement therapy. Am J Obstet Gynecol 1999; 181: 1400–1406
   PubMed Web of Science ®Google Scholar
• Rigg L A, Hermann H, Yen S SC. Absorption of estrogens from vaginal creams. N Engl J Med 1978; 298: 195–197
   PubMed Web of Science ®Google Scholar
• Sitruk-Ware R, De Lignieres B, Basdevant A, et al. Absorption of percutaneous oestradiol in postmenopausal women. Maturitas 1980; 2: 207–211
   PubMed Web of Science ®Google Scholar
• Hossain M, Quebe-Fehling E, Sergejew T, et al. Comparative bioequivalence studies with Estradot and Menorest transdermal systems. Maturitas 2003; 46: 187–198
   PubMed Web of Science ®Google Scholar
• Humberstone A J, Evans A M, Davis S R (2003) A comparative study of the pharmacokinetics of testosterone (T) following administration of a Metered-Dose Transdermal Spray (MDTS) to the abdomen or forearm in healthy postmenopausal women with low serum testosterone. Presented at The Endocrine Society's 85th Annual Meeting. 2003. PhiladelphiaUSA, Abstr
   Google Scholar
• Studd J, Pornel B, Marton I, , for the Aerodiol Study Group, et al. Efficacy and acceptability of intranasal 17β-oestradiol for menopausal symptoms: randomized dose-response study. Lancet 1999; 353: 1574–1578
   PubMed Web of Science ®Google Scholar
• Sitruk-Ware R. New progestogens: a review of their effects in perimenopausal and postmenopausal women. Drugs Aging 2004; 21: 865–883
   PubMed Web of Science ®Google Scholar
• Shulman L P, Yankov V, Uhl K. Safety and efficacy of a continuous once-a-week 17beta-estradiol/levonorgestrel transdermal system and its effects on vasomotor symptoms and endometrial safety in postmenopausal women: the results of two multicenter, double-blind, randomized, controlled trials. Menopause 2002; 3: 195–197
   Google Scholar
• The Writing Group for the PEPI Trial. Effects of hormone replacement therapy on endometrial histology in postmenopausal women. The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. JAMA 1996; 275: 370–375
   PubMed Web of Science ®Google Scholar
• Miyagawa K, Rösch J, Stanczyk F, et al. Medroxyprogesterone acetate interferes with ovarian steroid protection against coronary vasospasm. Nature Med 1997; 3: 324–327
   PubMed Web of Science ®Google Scholar
• Rosano G M, Webb C M, Chierchia S, et al. Natural progesterone, but not medroxyprogesterone acetate, enhances the beneficial effect of estrogen on exercise-induced myocardial ischemia in postmenopausal women. J Am Coll Cardiol 2000; 36: 2154–2159
   PubMed Web of Science ®Google Scholar
• Sitruk-Ware R, Small M, Kumar N, et al. Nestorone®: clinical applications for contraception and HRT. Steroids 2003; 68: 907–913
   PubMed Web of Science ®Google Scholar
• Kumar N, Koide S, Tsong Y-Y, Sundaram K. Nestorone: a progestin with a unique pharmacological profile. Steroids 2000; 65: 629–636
   PubMed Web of Science ®Google Scholar
• de Ziegler D, Fanchin R. Progesterone and progestins: applications in gynecology. Steroids 2000; 65: 671–679
   PubMed Web of Science ®Google Scholar
• de Ziegler D, Ferriani R, Moraes L A, Bulletti C. Vaginal progesterone in menopause: Crinone 4% in cyclical and constant combined regimes. Hum Reprod 2000; 15(Suppl 1)149–158
   PubMedGoogle Scholar
• Cicinelli E, de Ziegler D, Alfonso R, Nicoletti R, Bellavia M, Colafiglio G. Endometrial effects, bleeding control, and compliance with a new postmenopausal hormone therapy regimen based on transdermal estradiol gel and every-other-day vaginal progesterone in capsules: a 3-year pilot study. Fertil Steril 2005; 83: 1859–1863
   PubMed Web of Science ®Google Scholar
• Casanas-Roux F, Nisolle M, Marbaix E, et al. Morphometric, immunohistological and three-dimensional evaluation of the endometrium of menopausal women treated by oestrogen and Crinone, a new slow-release vaginal progesterone. Hum Reprod 1996; 11: 357–363
   PubMed Web of Science ®Google Scholar
• Zegers-Hochschild F, Balmaceda J P, Fabres C, et al. Prospective randomized trial to evaluate the efficacy of a vaginal ring releasing progesterone for IVF and oocyte donation. Hum Reprod 2000; 15: 2093–2097
   PubMed Web of Science ®Google Scholar
• Alexander N J, Baker E, Kaptein M, et al. Why consider vaginal drug administration?. Fertil Steril 2004; 82: 12
   Google Scholar
• Novak A, de la Loge C, Abetz L, et al. The combined contraceptive vaginal ring, NuvaRing: an international study of user acceptability. Contraception 2003; 67: 187–194
   PubMed Web of Science ®Google Scholar
• Carranza-Lira S, Gooch A L, Velasco-Díaz G, Solano J, Arzola-Paniagua A. Low and ultra low-dose estrogen therapy for climacteric symptom control – preliminary report. Int J Fertil Womens Med 2006; 51: 171–175
   PubMed Web of Science ®Google Scholar
• Sitruk-Ware R, Kumar N. Progestins and the brain. Effects on sexuality and quality of life, http://www.6thimsworkshop.com/sito/inside_pages/proceedings/sitruk_ware.pdf
   Google Scholar
• Mallareddy M, Hanes V, White W B. Drospirenone, a new progestogen, for postmenopusal women with hypertension. Drugs Aging 2007; 24: 453–466
   PubMed Web of Science ®Google Scholar
• Miles R A, Paulson R J, Lobo R A, et al. Pharmacokinetics and endometrial tissue levels of progesterone after administration by intramuscular and vaginal routes: a comparative study. Fertil Steril 1994; 62: 485–490
   PubMed Web of Science ®Google Scholar
• Maruo T, Mishell D R, Ben-Chetrit A, et al. Vaginal rings delivering progesterone and estradiol may be a new method of hormone replacement therapy. Fertil Steril 2002; 78: 1010–1016
   PubMed Web of Science ®Google Scholar
• Croxatto H B, Zepeda A. Transdermal contraceptive systems: innovative technology for the twenty-first century. Contraception. Newer Pharmacological Agents, Devices, and Delivery Systems, R Sitruk-Ware, W Bardin. Marcel Dekker, Inc, New York 1992; 101–115
   Google Scholar
• Rubinacci A, Peruzzi E, Modena A B, et al. Effect of low-dose transdermal E2/NETA on the reduction of postmenopausal bone loss in women. Menopause 2003; 10: 241–249
   PubMed Web of Science ®Google Scholar
• Sturdee D W, van de W P, von Holst T. Endometrial safety of a transdermal sequential estradiol–levonorgestrel combination. Climacteric 2002; 5: 170–177
   PubMed Web of Science ®Google Scholar
• Luukkainen T, Lahteenmaki P, Toivonen J. Levonorgestrel-releasing intrauterine device. Ann Med 1990; 22: 85–90
   PubMed Web of Science ®Google Scholar
• Sitruk-Ware R, Inki P. The levonorgestrel intrauterine system: long-term contraception and therapeutic effects. Women's Health 2005; 1: 171–182
   PubMedGoogle Scholar
• Sturdee D W, Rantala M L, Colau J C, et al. The acceptability of a small intrauterine progestogen-releasing system for continuous combined hormone therapy in early postmenopausal women. Climacteric 2004; 7: 404–411
   PubMed Web of Science ®Google Scholar
• Burger H G, Dudley E C, Robertson D M, Dennerstein L. Hormonal changes in the menopause transition. Recent Prog Horm Res 2002; 57: 257–275
   PubMedGoogle Scholar
• Critchley H. Endometrial effects of progestogens. Gynecol Forum 2003; 8: 6–10
   Google Scholar
• Jones R L, Critchley H O. Morphological and functional changes in human endometrium following intrauterine levonorgestrel delivery. Hum Reprod 2000; 15(Suppl 3)S162–S172
   PubMed Web of Science ®Google Scholar
• Backman T, Rauramo I, Jaakkola K, et al. Use of the levonorgestrel-releasing intrauterine system and breast cancer. Obstet Gynecol 2005; 106: 813–817
   PubMed Web of Science ®Google Scholar
• Anderson G L, Chlebowski R T, Rossouw J E, et al. Prior hormone therapy and breast cancer risk in the Women's Health Initiative randomized trial of estrogen plus progestin. Maturitas 2006; 20;55(2)103–115, Epub 2006 Jul 11
   Web of Science ®Google Scholar
• Wood C E, Sitruk-Ware R, Tsong Y Y, et al. Effects of estradiol with oral or intravaginal progesterone on risk markers for breast cancer in a postmenopausal monkey model. Menopause 2007; 14: 1–9
   PubMedGoogle Scholar
• Wood C E, Register T C, Lees C J, Chen H, Kimrey S, Cline J M. Effects of estradiol with micronized progesterone or medroxyprogesterone acetate on risk markers for breast cancer in postmenopausal monkeys. Breast Cancer Res Treat 2007; 101: 125–134
   PubMed Web of Science ®Google Scholar
• Montplaisir J, Lorrain J, Denesle R, et al. Sleep in menopause: differential effects of two forms of hormone replacement therapy. Menopause 2002; 8: 10–16
   Web of Science ®Google Scholar
• Kuhl H. Effects of progestogens on haemostasis. Maturitas 1996; 24: 1–19
   PubMed Web of Science ®Google Scholar
• Pinkerton J, Santen R. Alternatives to the use of estrogen in postmenopausal women. Endocrine Rev 1999; 20: 308–320
   PubMed Web of Science ®Google Scholar
• Grodstein F, Manson J E, Stampfer M J. Hormone therapy and coronary heart disease: the role of time since menopause and age at hormone initiation. J Women's Health (Larchmt) 2006; 15: 35–44
   PubMed Web of Science ®Google Scholar
• Shumaker S A, Legault C, Rapp S R, , WHIMS Investigators, et al. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: the Women's Health Initiative Memory Study: a randomized controlled trial. JAMA 2003; 289: 2651–2662
   PubMed Web of Science ®Google Scholar
• Nilsen J, Brinton R D. Impact of progestins on estrogen-induced neuroprotection: synergy by progesterone and 19-norprogesterone and antagonism by medroxyprogesterone acetate. Endocrinology 2002; 143: 205–212
   PubMed Web of Science ®Google Scholar
• Sitruk-Ware R, Plu-Bureau G. Exogenous progestagens and the human breast. Maturitas 2004; 49: 58–66
   PubMed Web of Science ®Google Scholar