Efficacy on Climacteric Symptoms of a New Estradiol Transdermal Patch with Active Matrix in Comparison with a Reference Reservoir Patch

Rovati, Lucio C.; Schmid, Karl M.; Giacovelli, Giampaolo; Bonn, Michael; Setnikar, I; Wolff, Friedrich; Genazzani, Andrea Riccardo

doi:10.1055/s-0031-1300529

Cited by 3 publications

(3 citation statements)

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“…the estradiol transdermal patch delivering daily 50 µg E 2 manufactured with the same technology used for D-25 and D-37.5. All experienced favorable efficacy and safety, confirming the existing clinical data of this E 2 matrix patch [32]. D-25 and D-37.5 were well tolerated by the skin on the application sites, D-25 being even better tolerated than placebo.…”

Section: Discussionsupporting

confidence: 77%

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Efficacy on Climacteric Symptoms and Safety of Low Dose Estradiol Transdermal Matrix Patches

Aloysio

Rovati²,

Giacovelli³

et al. 2011

Arzneimittelforschung

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Two estradiol (E2) transdermal patches releasing 25 micrograms/day E2 (D-25) or 37.5 micrograms/day E2 (D-37.5) were compared to a placebo patch on 156 patients in natural or surgical menopause suffering from at least 5 hot flushes per day, randomly and blindly assigned to three parallel groups of 52 patients each, to be treated continuously for 12 weeks, without progestin opposition. "Responders" (patients with less than 3 hot flushes per day at the end of treatment), were 82% and 90% under D-25 or D-37.5, respectively, both significantly (p < 0.001) more than under placebo (44%). Comparable efficacy was observed on severity of hot flushes, Kupperman Index and on the self-rated efficacy. Systemic adverse events occurred in 10%, 10% and 8% of patients, respectively, under D-25, D-37.5 or placebo. Occasional mild and transient itching and/or erythema on the site of application was reported by few patients and did never require discontinuation of application. In conclusion D-25 and D-37.5 were significantly more effective than placebo in relieving climacteric symptoms and were systemically and locally as well tolerated as placebo. D-25 (Demestril 25) releasing 25 micrograms/day E2 can therefore be recommended for low-dosed estrogen replacement therapy.

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Section: Discussionsupporting

confidence: 77%

“…The matrix of these patches was therefore defined "active" because it augments the absorption of E 2 also in absence of enhancers [34]. It represents a notable advantage over the conventional "reservoir" patches that contain absorption enhancers and are therefore less well tolerated by the skin [32,36,38].…”

Section: Discussionmentioning

confidence: 99%

Efficacy on Climacteric Symptoms and Safety of Low Dose Estradiol Transdermal Matrix Patches

Aloysio

Rovati²,

Giacovelli³

et al. 2011

Arzneimittelforschung

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“…Schlußfolgerungen: Das effektvolle pharmakokinetische Verhalten während der siebentägigen Anwendung, verbunden mit der guten allgemeinen und lokalen Verträglichkeit, sowie das Erfordernis die Pflaster nur einmal wöchentlich aufkleben zu müssen, verleihen den neuen Pflastern eine vorteilhafte Handhabung in der bei den meisten schweren postmenopausalen Beschwerden notwendigen Langzeit-Estrogen-Ersatztherapie. cepted by the women [21]. To further increase the practicability of the long-term ERT a new estradiol transdermal patch was developed with a sustained release of estradiol that needs only a once weekly application.…”

Section: Introductionunclassified