Efficacy and tolerability of pulsed estrogen therapy: A 12-week double-blind placebo-controlled study in highly symptomatic postmenopausal women

Climacteric

Volumn 5, Issue 3, 2002, Pages 249-258

  Rozenbaum, H ^a   Chevallier, O ^a   Moyal, M ^b   Durand, G ^c   Perineau, M ^d   This, P ^e  

^a Private Department of Gynecologist   (France)

^b Clinique De l'Essonne   (France)

^c Private Department of Gynecologist   (France)

^d Clinique Sarrus   (France)

^e CENTRE HOSPITALIER DE VERSAILLES   (France)

Author keywords

Hormone replacement therapy; Intranasal estradiol; Pulsed estrogen therapy; Vasomotor symptoms

Indexed keywords

ESTRADIOL; PLACEBO;

ADRENERGIC SYSTEM; ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DOSE TIME EFFECT RELATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ESTROGEN THERAPY; FEMALE; HOT FLUSH; HUMAN; HYPERHIDROSIS; MAJOR CLINICAL STUDY; MASTALGIA; MULTICENTER STUDY; PARALLEL DESIGN; POSTMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SPRAIN; SYMPTOM; VAGINA BLEEDING;

EID: 0036387625     PISSN: 13697137     EISSN: None     Source Type: Journal    
DOI: 10.1080/cmt.5.3.249.258     Document Type: Article

References (29)

1. O'Connell MB. Pharmacokinetic and pharmacologic variation between different estrogen products. J Clin Pharmacol 1995;35:18S-24S
2. De Lignieres B, Basdevant A, Thomas G, et al. Biological effects of estradiol-17β in postmenopausal women: oral versus percutaneous administration. J Clin Endocrinol Metab 1986;62:536-41
3. Stanczyk FZ, Shoupe D, Nunez V, et al. A randomized comparison of nonoral estradiol delivery in postmenopausal women. Am J Obstet Gynecol 1988;159:1540-6
4. The Transdermal HRT Investigators Group. A randomised study to compare the effectiveness, tolerability, and acceptability of two different transdermal estradiol replacement therapies. Int J Fertil Menopausal Stud 1993;38:5-11
5. Frenkel Y, Kopernik G, Lazer S, et al. Acceptability and skin reactions to transdermal estrogen replacement therapy in relation to climate. Maturitas 1994;20:31-6
6. Grebe SK, Adams JD, Feek CM. Systematic sensitization to ethanol by transdermal estrogen patches. Arch Dermatol 1993;129:379-80
7. de Vrijer B, Snijders MPML, Troostwijk AL, et al. Efficacy and tolerability of a new estradiol delivering matrix patch (Estraderm MX®) in postmenopausal women. Maturitas 1999;34:47-55
8. Cano A. Compliance to hormone replacement therapy in menopausal women controlled in a third level academic centre. Maturitas 1995;20:91-9
9. Rees MCP. The need to improve compliance to HRT. Br J Obstet Gynaecol 1997;104(Suppl 16):S1-3
10. Faulkner DL, Young C, Hutchins D, McCollam JS. Patient noncompliance with hormone replacement therapy: a nationwide estimate using a large prescription claims database. Menopause 1998;5:226-9
11. Devissaguet J-P, Brion N, Lhote O, Deloffre P. Pulsed estrogen therapy: pharmacokinetics of intranasal 17β-estradiol (S21400) in postmenopausal women and comparison with oral and transdermal formulations. Eur J Drug Metab Pharmacokinet 1999;24:265-71
12. Lievertz RW. Pharmacology and pharmacokinetics of estrogens. Am J Obstet Gynecol 1987;156:1289-93
13. Studd J, Pornel B, Marton I, et al. for the Aerodiol study group. Efficacy and acceptability of intranasal 17β-oestradiol for menopausal symptoms: randomised dose-response study. Lancet 1999;353:1574-8
14. Lopes P, Merkus HMWM, Nauman J, Bruschi F, Foidart J-M, Calaf J. Randomized comparison of intranasal and transdermal estradiol. Obstet Gynecol 2000;96:906-12
15. Mattsson LA, Christiansen C, Colau JC, et al. Clinical equivalence of intranasal and oral 17β-estradiol for postmenopausal symptoms. Am J Obstet Gynecol 2000;182:545-52
16. Pelissier C, de Kervasdoue A, Chuong VT, et al. Clinical evaluation, dose-finding and acceptability of Aerodiol®, the pulsed estrogen therapy for treatment of climacteric symptoms. Maturitas 2001;37:181-9
17. Gompel A, Bergeron C, Jondet M, et al. Endometrial safety and tolerability of Aerodiol® (intranasal estradiol) for 1 year. Maturitas 2000;36:209-15
18. Food and Drug Administration HRT Working Group. Guidance for clinical evaluation of combination estrogen/progestin-containing drug products used for hormone replacement therapy of postmenopausal women. Menopause 1995;2:131-6
19. Kupperman HS, Blatt MGH, Wiesbader H, Filler W. Comparative clinical evaluation of estrogenic preparations by the menopausal and amenorrheal indices. J Clin Endocrinol 1953;13:688-703
20. Wiklund I, Karlberg J, Mattsson LA. Quality of life of postmenopausal women on a regimen of transdermal estradiol therapy: a double blind placebo-controlled study. Am J Obstet Gynecol 1993;168:824-30
21. Utian WH, Burry KA, Archer DF, et al. Efficacy and safety of low, standard and high dosages of an estradiol transdermal system (Esclim) compared with placebo on vasomotor symptoms in highly symptomatic menopausal patients. Am J Obstet Gynecol 1999;181:71-9
22. Notelovitz M, Lenihan JP Jr, McDermott M, Kerber IJ, Nanavati N, Arce J-C. Initial 17β-estradiol dose for treating vasomotor symptoms. Obstet Gynecol 2000;95:726-31
23. Lopes P, Rozenberg S, de Graaf J, Fernandez-Villoria E, Marianowski L. Aerodiol® versus the transdermal route: perspective for patient preference. Maturitas 2001;38(Suppl 1):S1-58
24. Kerdelhue B, Jolette J. The influence of the route of administration of 17β-estradiol, intravenous (pulsed) versus oral, upon DMBA induced mammary tumour development in ovariectomised rats. Breast Cancer Res Treat 2002;73:13-22
25. Cohen L, Coxwell WL, Melchione T, et al. Low-dose 17β-estradiol matrix transdermal system in the treatment of moderate-to-severe hot flushes in postmenopausal women. Curr Ther Res 1999;60:534-47
26. Speroff L, Whitcomb RW, Kempfert NJ, Boyd RA, Paulissen JB, Rowan JP. Efficacy and local tolerance of a low-dose, 7-day matrix estradiol transdermal system in the treatment of menopausal vasomotor symptoms. Obstet Gynecol 1996;88:587-92
27. Ettinger B, Genant HK, Steiger P, Madvig P. Low-dosage micronized 17β-estradiol prevents bone loss in postmenopausal women. Am J Obstet Gynecol 1992;166:479-88
28. Espeland MA, Stefanick ML, Kritz-Silverstein D, et al. Effect of postmenopausal hormone therapy on body weight and waist and hip girths. Postmenopausal Estrogen/Progestin Interventions Study Investigators. J Clin Endocrinol Metab 1997;82:1549-56
29. The 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. J Am Med Assoc 1995; 273:199-208