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Abstract
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.
Keywords
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References
- Estrogen therapy for postmenopausal symptoms and prevention of osteoporosis.J Clin Pharmacol. 1995; 35: 2S-10S
- Guidelines for counseling postmenopausal women about preventive hormone therapy.Ann Intern Med. 1992; 117: 1038-1041
- Reduced mortality associated with long-term postmenopausal estrogen therapy.Obstet Gynecol. 1996; 87: 6-12
- A risk-benefit appraisal of transdermal estradiol therapy.Drug Safety. 1993; 9: 365-379
- Transdermal Estradiol. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in the treatment of menopausal complaints.Drugs. 1990; 40: 561-582
- Transdermal Estradiol: A review of its pharmacological profile and therapeutic potential in the prevention of postmenopausal osteoporosis.Drugs and Aging. 1992; 2: 487-507
- Contact dermatitis to transdermal estradiol system.J Am Acad Dermatol. 1989; 20: 508-519
- Allergic contact dermatitis from hydroxypropyl cellulose in transdermal estradiol patch.Contact Dermatitis. 1988; 18: 106-107
- Allergic contact dermatitis from nitroglycerin and estradiol transdermal therapeutic systems.Contact Dermatitis. 1992; 26: 53
- Bioäquivalenz von zwei Estradiol-pflastern.in: Rietbrock N Keller-Stanislawsky B Woodcock BG Die Haut als Transportorgan für Arzneistoffe. Steinkoppf Verlag, Darmstadt1990: 71-76
- Use of two types of estradiol-releasing skin patches for menopausal subjects in a tropical climate.Am J Obstet Gynecol. 1992; 166: 2005-2010
- 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
- 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
- Clinical experience with a seven-day estradiol transdermal system for estrogen replacement therapy.Am J Obstet Gynecol. 1995; 173: 998-1004
- Comparative clinical evaluation of estrogenic preparations by the menopausal and amenorrheal indices.J Clin Endocrinol Metab. 1953; 13: 688-703
- The measurement of estrone sulfate in plasma.Steroids. 1971; 18: 463-472
- Comparison of serum oestrogen concentrations in post-menopausal women taking oestrone sulphate and oestradiol.Brit Med J. 1978; 1: 140-142
- 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
- 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
Article info
Publication history
Accepted:
March 27,
1997
Received in revised form:
March 25,
1997
Received:
June 25,
1996
Identification
Copyright
© 1997 Published by Elsevier Inc.
