Efficacy and tolerability of a new estradiol delivering matrix patch (Estraderm MX(®)) in postmenopausal women

Maturitas

Volumn 34, Issue 1, 2000, Pages 47-55

  De Vrijer, Barbra ^a   Snijders, Marc P M L ^b   Troostwijk, Arthur L ^c   Thé, Sien ^d   Iding, Robert J ^e   Friese, Sietze ^f   Smit, Dieke A ^g   Schierbeek, Jaap M ^h   Brandts, Henk ⁱ   Van Kempen, Paul J H ^j   Van Buuren, Ineke ^k   Monza, Giancarlo ^l  

^a JEROEN BOSCH HOSPITAL   (Netherlands)

^b St Maartens Gasthuis   (Netherlands)

^c HOSPITAL DE WEEZENLANDEN   (Netherlands)

^d Location Alkmaar   (Netherlands)

^e CPRLab   (Netherlands)

^f Ignatius Hospital   (Netherlands)

^g TWENTEBORG HOSPITAL   (Netherlands)

^h DEVENTER HOSPITAL   (Netherlands)

ⁱ MEDISCH SPECTRUM TWENTE   (Netherlands)

^j GELDERSE VALLEI HOSPITAL   (Netherlands)

^k Ciba Ltd   (Netherlands)

^l Ciba   (Italy)

more..

Author keywords

Hormone replacement therapy; Hot flushes; Matrix patch; Postmenopausal; Transdermal system

Indexed keywords

ESTRADERM MX; ESTRADIOL; PLACEBO; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG TOLERABILITY; ENDOMETRIUM HYPERPLASIA; ERYTHEMA; FEMALE; HORMONE SUBSTITUTION; HOT FLUSH; HUMAN; LEUKORRHEA; MASTALGIA; PATIENT COMPLIANCE; POSTMENOPAUSE; RANDOMIZED CONTROLLED TRIAL; SKIN IRRITATION; SWEATING; TRANSDERMAL PATCH;

ADMINISTRATION, CUTANEOUS; ADULT; DOUBLE-BLIND METHOD; ESTRADIOL; FEMALE; HORMONE REPLACEMENT THERAPY; HOT FLASHES; HUMANS; MIDDLE AGED; POSTMENOPAUSE;

EID: 0034650647     PISSN: 03785122     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0378-5122(99)00085-7     Document Type: Article

References (24)

1. Balfour J.A., Heel R.C. Transdermal estradiol. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in the treatment of menopausal complaints. Drugs. 40:1990;561-582.
2. Balfour J.A., McTavish D. Transdermal estradiol. A review of its pharmacological profile and therapeutic potential in the prevention of postmenopausal osteoporosis. Drugs Aging. 2:1992;487-507.
3. Cheang A., Sitruk-Ware R., Utian W.H. A risk-benefit appraisal of transdermal estradiol therapy. Drug Saf. 9:1993;365-379.
4. Kuhl H. Pharmacokinetics of estrogens and progestogens. Maturitas. 12:1990;171-197.
5. McBurney E.I., Noel S.B., Collins J.H. Contact dermatitis to transdermal estradiol system. J Am Acad Dermatol. 20:1989;508-510.
6. Torres V., Lopes J.C., Leite L. Allergic contact dermatitis from nitroglycerin and estradiol transdermal therapeutic systems. Contact Dermatitis. 26:1992;53-54.
7. Merz P.G., Keller-Stanislawsky B. Bioäquivalenz von zwei Estradiol-pflastern. Rietbrock N., Keller-Stanislawsky B., Woodcock B.G. Die Haut als Transportorgan für Arzneistoffe. 1990;Steinkoppf, Darmstadt.
8. McCarthy T., Dramusic V., Ratnam S. Use of two types of estradiol-releasing skin patches for menopausal subjects in a tropical climate. Am J Obstet Gynecol. 166:1992;2005-2010.
9. Howie H., Heimer G. A multicenter randomized parallel group study comparing a new estradiol matrix patch and a registered reservoir patch. J North Am Men Soc. 2:1995;43-48.
10. Studd J.W.W., McCarthy K., Zamblera D., Burger H.G., Silberberg S., Wren B., Dain M.P., Le Lann L., Vandepol C. Efficacy and tolerability of Menorest® compared to Premarin® in the treatment of postmenopausal women. A randomized, multicentre, double-blind, double-dummy study. Maturitas. 22:1995;105-114.
11. Gordon S.F. Clinical experience with a seven-day estradiol transdermal system for estrogen replacement therapy. Am J Obstet Gynecol. 173:1995;998-1004.
12. Kupperman H.S., Blatt M.H.G., Wiesbader H., Filler W. Comparative clinical evaluation of estrogenic preparations by the menopausal and amenorrheal indices. Endocrinology. 13:1953;688-703.
13. Steingold K.A., Laufer L., Chetkowski R.J., DeFazio J.D., Matt D.W., Meldrum D.R., Judd H.L. Treatment of hot flushes with transdermal estradiol administration. J Clin Endocrinol Metab. 61:1985;627-632.
14. Mishell D.R. Estrogen replacement therapy: an overview. Am J Obstet Gynecol. 161:1989;1825-1827.
15. Shapiro S.M.B., Kelly J.P., Rosenberg L., Kaufman D.W., Helmrich S.P., Rosenshein N.B., Lewis J.L., Knapp R.C., Stolley P.D., Schottenfeld D. Risk of localized and widespread endometrial cancer in relation to recent and discontinued use of conjugated estrogens. New Engl J Med. 313:1985;969-972.
16. Gelfand M.M., Ferenczy A. A prospective 1-year study of estrogen and progestin in post-menopausal women: effects on the endometrium. Obstet Gynecol. 74:1989;398-402.
17. Paterson M.E., Wade-Evans T., Sturdee D.W., Thom M.H., Studd J.W. Endometrial disease after treatment with oestrogens and progestogens in the climacteric. Br Med J. 280:1980;822-824.
18. Schiff I., Sela H.K., Cramer D., Tulchinksy D., Ryan K.J. Endometrial hyperplasia in women on cyclic or continuous estrogen regimens. Fertil Steril. 37:1982;79-82.
19. Utian W.H. Transdermal estradiol overall safety profile. Am J Obstet Gynecol. 156:1987;1335-1338.
20. Clisham J.H., Judd H., Fu Y., Lozano K., Cedars M. Bleeding patterns and endometrial histology (EH) with long-term transdermal estradiol therapy. Fertil Steril. Suppl:1988;S24-25.
21. Williams D.B., Voigt B.J., Fu Y.S., Schoenfeld M.J., Judd H.L. Assessment of less than monthly progestin therapy in postmenopausal women given estrogen replacement. Obstet Gynecol. 84:1994;787-793.
22. Woodruff J.D., Picker J.H. Incidence of endometrial hyperplasia in postmenopausal women taking conjugated estrogens (Premarin) with medroxyprogesterone acetate or conjugated estrogens alone. Am J Obstet Gynecol. 170:1994;1213-1223.
23. Lindgren R., Risberg B., Hammar M., Berg G. Transdermal hormonal replacement therapy with transdermal progestin every second month. Maturitas. 22:1995;25-30.
24. Carmichael A.J. Skin sensitivity and transdermal drug delivery. A review of the problem. Drug Saf. 10:1994;151-159.