Comparison of the efficacy and tolerability of a new once-a-week matricial estradiol transdermal system (Estrapatch® 40 and Estrapatch® 60) with a twice week system

Raynaud, Jean‐Pierre; Lévrier, M; Calaf, Joaquím; Laur, C M; Pélissier, C

doi:10.1016/j.jsbmb.2005.01.001

Cited by 4 publications

(2 citation statements)

References 32 publications

(36 reference statements)

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“…Of these, 330 were excluded; 59 included fewer than 20 women per study arm and 54 were not an RCT; 126 did not clearly state a sample size calculation; 52 did not measure vasomotor symptoms as the primary outcome; 39 were secondary analysis. Following these exclusions, 214 RCT were included…”

Section: Resultsmentioning

confidence: 99%

Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review

Iliodromiti

Wang

Lumsden

et al. 2019

BJOG

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Background There is substantial variation in how menopausal vasomotor symptoms are reported and measured among intervention studies. This has prevented meaningful comparisons between treatments and limited data synthesis. Objectives To review systematically the outcome reporting and measures used to assess menopausal vasomotor symptoms from randomised controlled trials of treatments. Search strategy We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials from inception to May 2018. Selection criteria Randomised controlled trials with a primary outcome of menopausal vasomotor symptoms in women and a sample size of at least 20 women per study arm. Data collection and analysis Data about study characteristics, primary vasomotor‐related outcomes and methods of measuring them. Main results The search identified 5591 studies, 214 of which were included. Forty‐nine different primary reported outcomes were identified for vasomotor symptoms and 16 different tools had been used to measure these outcomes. The most commonly reported outcomes were frequency (97/214), severity (116/214), and intensity (28/114) of vasomotor symptoms or a composite of these outcomes (68/214). There was little consistency in how the frequency and severity/intensity of vasomotor symptoms were defined. Conclusions There is substantial variation in how menopausal vasomotor symptoms have been reported and measured in treatment trials. Future studies should include standardised outcome measures which reflect the priorities of patients, clinicians, and researchers. This is most effectively achieved through the development of a Core Outcome Set. This systematic review is the first step towards development of a Core Outcome Set for menopausal vasomotor symptoms. Tweetable summary Menopausal hot flushes and night sweats have been reported in 49 different ways in clinical research. A core outcome set is urgently required.

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Section: Resultsmentioning

confidence: 99%

Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review

Iliodromiti

Wang

Lumsden

et al. 2019

BJOG

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show abstract

“…Transdermal delivery of estrogens and progestogens for contraception and hormone replacement therapy has been evaluated in numerous researches (Agrawal and Pruthi, 2011;Burkman, 2007;Raynaud, 2005). The use of long acting implants and patches are currently two conventional methods that are available in the pharmaceutical markets for this indication (Chrisman et al, 2006;Mansour et al, 2011;Toole et al, 2002;Caruso, 2003).…”

Section: Introductionmentioning

confidence: 99%

Formation of polymeric films containing supersaturated levonorgestrel contraceptive drug by transdermal metered dose aerosol

Hoseini¹

2013

Afr. J. Pharm. Pharmacol.

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Due to the benefits of transdermal sprays, formulation of levonorgestrel as a transdermal metered dose aerosol was studied in this work. Simultaneously, super-saturation was evaluated as an effective method to increase the transfer of active ingredients to the skin. By using anti-nucleant polymers and solvent evaporation after spraying, we could form films containing supersaturated drug after spraying the formulation and inhibiting crystallization. Film formation and visual properties of films were investigated. The kinetics of weight loss and super saturation after film formation was calculated and finally, the rate of drug release from cellulose acetate membrane was assessed. In the formulations containing higher amounts of polyvinyl pyrrolidone (PVP) and 4 mg of levonorgestrel, 84.31% of drug was released during 4 h. While, in formulation with 2 mg drug, the maximum 95.79% of the drug was released during that time. According to these results, this kind of transdermal metered dose aerosol could be suggested as a suitable form for delivery of levonorgestrel through the skin.

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Comparison of efficacy and local tolerability of estradiol metered-dose transdermal spray to estradiol patch in a network meta-analysis

Kovacs¹,

Zelei²,

Vokó

2016

Climacteric

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Comparison of the efficacy and tolerability of a new once-a-week matricial estradiol transdermal system (Estrapatch® 40 and Estrapatch® 60) with a twice week system

Cited by 4 publications

References 32 publications

Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review

Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review

Formation of polymeric films containing supersaturated levonorgestrel contraceptive drug by transdermal metered dose aerosol

Comparison of efficacy and local tolerability of estradiol metered-dose transdermal spray to estradiol patch in a network meta-analysis

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