A RANDOMISED STUDY TO COMPARE THE EFFICACY AND SAFETY OF a NEW 17β‐OESTRADIOL TRANSDERMAL MATRIX PATCH WITH ESTRADERM TTS 50 IN HYSTERECTOMISED POSTMENOPAUSAL WOMEN

The collaborators are listed on page 758Objective Evaluate the efficacy and acceptability of a novel vaginal ring delivering oestradiol acetate (Menoring) versus oral oestradiol for relief of climacteric symptoms in postmenopausal women. Design Prospective, multicentre, randomised, double-blind, comparator-controlled, parallel group study.Setting Twenty-one centres in the United Kingdom.Population Postmenopausal women, aged <65 years experiencing 20 hot flushes/night sweats per week for two consecutive weeks. Methods Patients received a vaginal ring releasing oestradiol acetate at a rate equivalent to 50 Ag/day in addition to placebo tablets (vaginal ring group) or oral oestradiol 1 mg/day in addition to placebo vaginal ring (oral group) for 24 weeks. For patients with inadequate control of vasomotor symptoms, dosage was doubled at 12 weeks. Non-hysterectomised women received norethisterone 1 mg/day for 12 days in each 28 day cycle. Main outcome measures Efficacy was assessed by change in climacteric symptoms measured by the Greene Climacteric Scale, as well as mean change in frequency of hot flushes/night sweats. Results A total of 159 patients were enrolled (84 vaginal ring, 75 oral). Significant improvement ( P < 0.05) in mean total Greene Climacteric Scale scores in both treatment groups was observed at 12 and 24 weeks and for every subscale score including anxiety, depression and sexual dysfunction ( P < 0.05). In both groups, frequency of hot flushes/night sweats was significantly reduced ( P < 0.001) at 12 and 24 weeks. No significant between-group differences were noted at 12 or 24 weeks. Conclusions The oestradiol vaginal ring significantly improved climacteric symptoms as measured by Greene Climacteric Scale scores and reduced the frequency of hot flushes/night sweats. Efficacy and safety of vaginal ring oestradiol were comparable with those of oral therapy. Patient evaluations of oestradiol vaginal ring tolerability and acceptability were excellent.

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A RANDOMISED STUDY TO COMPARE THE EFFICACY AND SAFETY OF a NEW 17β‐OESTRADIOL TRANSDERMAL MATRIX PATCH WITH ESTRADERM TTS 50 IN HYSTERECTOMISED POSTMENOPAUSAL WOMEN

Cited by 5 publications

References 28 publications

Effects of postmenopausal hormone replacement therapy on lipid, lipoprotein, and apolipoprotein (a) concentrations: analysis of studies published from 1974–2000

Effects of postmenopausal hormone replacement therapy on lipid, lipoprotein, and apolipoprotein (a) concentrations: analysis of studies published from 1974–2000

Randomized Comparison of Intranasal and Transdermal Estradiol

The effect of a novel vaginal ring delivering oestradiol acetate on climacteric symptoms in postmenopausal women

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