Research Article| Volume 27, ISSUE 3, P285-292, July 1997

Download started.


Efficacy and tolerability of ®estraderm MX, a new estradiol matrix patch

      This paper is only available as a PDF. To read, Please Download here.


      Objectives: To assess the efficacy and tolerability of a new matrix patch delivering 0.05 mg estradiol per day (Estraderm MX 50) in postmenopausal women with moderate to severe postmenopausal symptoms. Methods: A multicenter, double-blin, randomized, between-patient, placebo controlled trial in 109 postmenopausal women was carried out. Patches were applied twice weekly for 12 weeks. Patients were assessed at 4, 8 and 12 weeks of treatment. The primary efficacy variable was change from baseline in mean number of moderate to severe hot flushes (including night sweats) per 24 h during the last 2 weeks of treatment. Other variables included Kupperman Index, local and systemic tolerability. Plasma concentrations of estradiol (E2), estrone (E1) and estrone sulfate (E1S) were determined before and after treatment. Results: Estraderm MX was significantly superior to placebo (P < 0.001) in reducing mean number of moderate to severe hot flushes (including night sweats) per 24 h after 4, 8 and 12 weeks of treatment. The estimate of treatment group differences after 12 weeks was 4.2 hot flushes (95% confidence interval: 2.6–5.5). Estraderm MX also significantly reduced Kupperman Index at all time points compared to placebo (P < 0.001). Estraderm MX induced increases in mean E2, E1 and E1S plasma levels as expected (E2: baseline 2.7 pg/ml, 12 weeks 38.9 pg/ml; E1: baseline 18.8 pg/ml, 12 weeks 41.6 pg/ml; E1S: baseline 235.6 pg/ml, 12 weeks 765.1 pg/ml). Overall rates of adverse experiences were similar for Estraderm MX and placebo. The number of patients reporting skin irritation was low and similar in both groups. Conclusions: Estraderm MX 50, a new matrix patch, offers an effective and well tolerated dosage form for transdermal delivery of 0.05 mg E2 per day.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Maturitas
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Sagraves R
        Estrogen therapy for postmenopausal symptoms and prevention of osteoporosis.
        J Clin Pharmacol. 1995; 35: 2S-10S
        • American College of Physicians
        Guidelines for counseling postmenopausal women about preventive hormone therapy.
        Ann Intern Med. 1992; 117: 1038-1041
        • Ettinger B
        • Friedman GD
        • Bush T
        • Quesenberry CP
        Reduced mortality associated with long-term postmenopausal estrogen therapy.
        Obstet Gynecol. 1996; 87: 6-12
        • Cheang A
        • Sitruk-Ware R
        • Utian WH
        A risk-benefit appraisal of transdermal estradiol therapy.
        Drug Safety. 1993; 9: 365-379
        • Balfour JA
        • Heel RC
        Transdermal Estradiol. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in the treatment of menopausal complaints.
        Drugs. 1990; 40: 561-582
        • Balfour JA
        • McTavish D
        Transdermal Estradiol: A review of its pharmacological profile and therapeutic potential in the prevention of postmenopausal osteoporosis.
        Drugs and Aging. 1992; 2: 487-507
        • McBurney EI
        • Noel SB
        • Collins JH
        Contact dermatitis to transdermal estradiol system.
        J Am Acad Dermatol. 1989; 20: 508-519
        • Schwartz BK
        • Clendenning WE
        Allergic contact dermatitis from hydroxypropyl cellulose in transdermal estradiol patch.
        Contact Dermatitis. 1988; 18: 106-107
        • Torres V
        • Lopes JC
        • Leite L
        Allergic contact dermatitis from nitroglycerin and estradiol transdermal therapeutic systems.
        Contact Dermatitis. 1992; 26: 53
        • Merz PG
        • Keller-Stanislawsky B
        Bioäquivalenz von zwei Estradiol-pflastern.
        in: Rietbrock N Keller-Stanislawsky B Woodcock BG Die Haut als Transportorgan für Arzneistoffe. Steinkoppf Verlag, Darmstadt1990: 71-76
        • 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. 1992; 166: 2005-2010
        • Howie H
        • Heimer G
        A multicenter randomized parallel group study comparing a new estradiol matrix patch and a registered reservoir patch.
        J Nth Am Men Soc. 1995; 2: 43-48
        • Studd JWW
        • McCarthy K
        • Zamblera D
        • Burger HG
        • Silberberg S
        • Wren B
        • Dain MP
        • Le Lann L
        • Vandepol C
        Efficacy and tolerability of Menorest® compared to Premarin® in the treatment of postmenopausal women. A randomized, Multicenter, double-blind, double-dummy study.
        Maturitas. 1995; 22: 105-114
        • Gordon SF
        Clinical experience with a seven-day estradiol transdermal system for estrogen replacement therapy.
        Am J Obstet Gynecol. 1995; 173: 998-1004
        • Kupperman HS
        • Blatt MHG
        • Wiesbader H
        • Filler W
        Comparative clinical evaluation of estrogenic preparations by the menopausal and amenorrheal indices.
        J Clin Endocrinol Metab. 1953; 13: 688-703
        • Loriaux DL
        • Ruder HJ
        • Lipsett MB
        The measurement of estrone sulfate in plasma.
        Steroids. 1971; 18: 463-472
        • Anderson ABM
        • Sklowsky E
        • Sayers L
        • Steele PA
        • Turnbull AC
        Comparison of serum oestrogen concentrations in post-menopausal women taking oestrone sulphate and oestradiol.
        Brit Med J. 1978; 1: 140-142
        • Mueller P
        • Botta L
        • Ezzet F
        Bioavailability of estradiol from a new matrix and a conventional reservoir type transdermal system (®Estraderm MX 50 and ®Estraderm TTS 50).
        Eur J Clin Pharmacol. 1996; 51: 327-330
        • Selby LP
        • McGarrigle HHG
        • Peacock M
        Comparison of the effects of oral and transdermal oestradiol administration on estrogen metabolism, protein synthesis, gonadotrophin release, bone turnover and climacteric symptoms in postmenopausal women.
        Clin Endocrinol. 1989; 30: 241-249