Efficacy and tolerance of Menorest® compared to Premarin® in the treatment of postmenopausal women. A randomised, multicentre, double-blind, double-dummy study

Studd, John; McCarthy, Kathleen A.; Zamblera, D.; Burger, Henry G.; Silberberg, S.; Wren, Barry G.; Dain, Marie-Paule; Lann, L. Le; Vandepol, C.

doi:10.1016/0378-5122(95)00910-d

Cited by 28 publications

(8 citation statements)

References 24 publications

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“…40 Common side effects, including breast tenderness and breakthrough bleeding, seem more related to the dosage of estrogen than route of administration. 35,40,41 Skin tolerability was generally good, but was the reason for withdrawal in up to 8% of patients during 12 weeks of follow-up. 35 However, a trial conducted for one year described a 22% withdrawal rate due to cutaneous side effects in a transdermal matrix patch group and a 50% withdrawal rate in a reservoir patch group.…”

Section: Efficacy Of Transdermal Estradiol In Treatment Of Hot Flashesmentioning

confidence: 97%

“…Although most trials include patients with moderate to severe hot flashes, the number of hot flashes necessary for such classification is not the same across the different studies. 34 Most of the published research is in the form of The first studies of the efficacy of transdermal estradiol in the treatment of hot flashes were performed comparing the transdermal estradiol patch (0.02-0.1 mg/day, reservoir or matrix) with either placebo [35][36][37][38][39] or oral conjugated equine estrogens 35,40,41 (0.625 mg/day or 1.25 mg/day). These early randomized placebo-controlled studies reported a significant reduction in the frequency and severity of hot flashes in comparison with placebo.…”

Section: Efficacy Of Transdermal Estradiol In Treatment Of Hot Flashesmentioning

confidence: 99%

“…39 There were no significant differences between patients treated with oral estrogens and those treated with the transdermal estradiol patch, and both formulations were effective in the treatment of hot flashes. 35,40,41 Therefore, 0.05 mg/day of transdermal estradiol seems to be equivalent to 0.625 mg/day of oral conjugated equine estrogens. In one study, clinical assessment at week 4 found that oral conjugated equine estrogens (0.625 mg/day) achieved improvement earlier than the transdermal estradiol patch (0.05 mg/day), but both groups showed similar clinical responses at 12 weeks.…”

Section: Efficacy Of Transdermal Estradiol In Treatment Of Hot Flashesmentioning

confidence: 99%

“…54 However, it seems that the transdermal routes do so to a lesser extent, which is probably due to the lower plasma levels necessary for symptom control. 35,40,41 Nonetheless, a progestin should always be administered simultaneously in women with an intact uterus, given that this practice has been shown to reduce the risk of endometrial cancer associated with unopposed estrogen therapy. [55][56][57][58] Estrogen has been shown to affect cardiovascular risk factors, such as lipid levels.…”

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confidence: 99%

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Clinical efficacy of estradiol transdermal system in the treatment of hot flashes in postmenopausal women

Castelo-Branco¹,

Soveral²

2014

RRTD

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Hot flashes are among the most common symptoms of estrogen deprivation associated with menopause. Hot flashes affect quality of life in menopausal women and constitute the main indication for hormonal replacement. Treatment using estrogens with or without a progestin is highly effective in reducing the frequency and intensity of hot flashes. There are several estrogen formulations available for the treatment of menopausal symptoms, including oral, transdermal, intranasal, and vaginal preparations. Within the transdermal group, several preparations exist and all have been shown to be effective in the control of hot flashes. Transdermal estrogens constitute an effective treatment for menopausal hot flashes and may have additional beneficial effects compared with oral treatment, given that first-pass hepatic metabolism is avoided using the transdermal route. Transdermal estrogens should be considered as a viable treatment option for symptomatic menopausal women. When it has been decided to use the transdermal route, the woman should be informed of the benefits and side effects of each transdermal system and her preference taken into account when recommending a specific transdermal preparation.

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Section: Efficacy Of Transdermal Estradiol In Treatment Of Hot Flashesmentioning

confidence: 97%

Section: Efficacy Of Transdermal Estradiol In Treatment Of Hot Flashesmentioning

confidence: 99%

Section: Efficacy Of Transdermal Estradiol In Treatment Of Hot Flashesmentioning

confidence: 99%

mentioning

confidence: 99%

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Clinical efficacy of estradiol transdermal system in the treatment of hot flashes in postmenopausal women

Castelo-Branco¹,

Soveral²

2014

RRTD

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“…The clinical development of the 5-cm 2 patch has been primarily based on key safety data for the established matrix patch, Menorest Ò (Novartis Pharmaceuticals, Basel, Switzerland), and on the demonstration of bioequivalence to Menorest [14][15][16][17][18][19][20][21][22] . The tolerability and bioavailability of Menorest have been compared with the estradiol transdermal system, Climara Ò23,24 (Berlex Laboratories, Wayne, NJ, USA), a 12.5-cm 2 patch.…”

Section: Introductionmentioning

confidence: 99%

Comparative study to evaluate skin irritation and adhesion of Estradot^®and Climara^®in healthy postmenopausal women

et al. 2002

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Objectives To compare the local tolerability, adhesion and estradiol delivery of a 5-cm 2 transdermal patch (Estradot Ò , Novartis Pharmaceuticals, Basel, Switzerland) and a 12.5-cm 2 patch (Climara Ò , Berlex Laboratories, Wayne, NJ, USA). MethodsThis was an open-label, randomized, intrapatient, comparative study. One hundred healthy postmenopausal women applied the 50 mg/day 5-cm 2 patch and the 12.5-cm 2 patch concurrently for 7 days; safety and tolerability were assessed. Twelve women continued to apply the 5-cm 2 and 12.5-cm 2 patches separately for 7 days in a two-way cross-over study, to investigate the reproducibility of estradiol delivery. ResultsThe proportion of subjects with a clinically significant erythema score was higher with the 12.5-cm 2 patch. The 5-cm 2 patch had a significantly lower incidence of very slight erythema than the larger patch (21.4% vs. 32.3%; p = 0.0028). Overall erythema scores were 0.22 and 0.41, respectively. More 5-cm 2 patches had > 90% adherence than the 12.5-cm 2 patches (87.5% vs. 82.0%, not significant) and fewer became detached (0.5% vs. 3.0%). Both the patches showed reproducible delivery of estradiol. ConclusionThe 5-cm 2 patch was associated with less skin irritation and better adherence than the 12.5-cm 2 patch, although the majority of the differences were not significant. The 5-cm 2 patch was well tolerated and showed reproducible estradiol delivery, as did the 12.5-cm 2 patch.

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Commonly Used Types of Postmenopausal Estrogen for Treatment of Hot Flashes

Nelson

2004

JAMA

275

113

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1940s to treat menopausal symptoms. During the ensuing years, observational studies indicated additional health benefits for estrogen users such as prevention of chronic diseases like cardiovascular disease and osteoporosis. 1 A national survey conducted in 1995 indicated that 37% of women aged 50 years or older were using estrogen for multiple purposes. 2 Estrogen use has decreased since 2002 3,4 when the results of the Women's Health Initiative (WHI), the first large randomized controlled trial of estrogen for prevention of disease, released its findings contradicting previous beliefs about cardiovascular benefits. 5 In this study, women using conjugated equine estrogen (CEE) and medroxyprogesterone acetate had significantly increased risks of coronary heart disease events, strokes, and breast cancer than women taking placebo. 5 The US Food and Drug Administration recently ordered estrogen safety warnings on product labels referring to WHI findings and altered approved indications for its use. 6,7 Package inserts indicate that treatment of menopausal symptoms remains an indication for estrogen use, although now physicians are advised to use the smallest effective dose for the shortest duration possible. 7 The National Institutes of Health added steroidal estrogens to its list of known hu

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Efficacy and tolerance of Menorest® compared to Premarin® in the treatment of postmenopausal women. A randomised, multicentre, double-blind, double-dummy study

Cited by 28 publications

References 24 publications

Clinical efficacy of estradiol transdermal system in the treatment of hot flashes in postmenopausal women

Clinical efficacy of estradiol transdermal system in the treatment of hot flashes in postmenopausal women

Comparative study to evaluate skin irritation and adhesion of Estradot^®and Climara^®in healthy postmenopausal women

Commonly Used Types of Postmenopausal Estrogen for Treatment of Hot Flashes

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Efficacy and tolerance of Menorest® compared to Premarin® in the treatment of postmenopausal women. A randomised, multicentre, double-blind, double-dummy study

Cited by 28 publications

References 24 publications

Clinical efficacy of estradiol transdermal system in the treatment of hot flashes in postmenopausal women

Clinical efficacy of estradiol transdermal system in the treatment of hot flashes in postmenopausal women

Comparative study to evaluate skin irritation and adhesion of Estradot®and Climara®in healthy postmenopausal women

Commonly Used Types of Postmenopausal Estrogen for Treatment of Hot Flashes

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Product

Resources

About

Comparative study to evaluate skin irritation and adhesion of Estradot^®and Climara^®in healthy postmenopausal women