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


METHODS
Prospective, multicentre, randomised, double-blind, comparator-controlled, parallel group study.


METHODS
Twenty-one centres in the United Kingdom.


METHODS
Postmenopausal women, aged <65 years experiencing > or =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 microg/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.


METHODS
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.
Buckler
Helen
H
Department of Endocrinology, University of Manchester and Hope Hospital, Stott Lane, Salford M6 8HD, UK.
Al-Azzawi
Farook
F
D000282:Administration, Intravaginal; D000284:Administration, Oral; D000328:Adult; D002979:Climacteric / Q000187:drug effects*; D004311:Double-Blind Method; D004958:Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D008875:Middle Aged; D017060:Patient Satisfaction; D017698:Postmenopause; D011355:Prodrugs; D011446:Prospective Studies
D011355:Prodrugs; D004958:Estradiol