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A comparative study of safety and efficacy of continuous low dose oestradiol released from a vaginal ring compared with conjugated equine oestrogen vaginal cream in the treatment of postmenopausal urogenital atrophy
Article first published online: 19 AUG 2005
DOI: 10.1111/j.1471-0528.1996.tb09741.x
Issue
1471-0528/asset/cover.gif?v=1&s=b4e1d96c46e18c61210d584b63c13ee375cf562b "BJOG: An International Journal of Obstetrics & Gynaecology")
BJOG: An International Journal of Obstetrics & Gynaecology
Volume 103, Issue 4, pages 351–358, April 1996
Additional Information
How to Cite
Ayton, R. A., Darting, G. M., Murkies, A. L., Farrell, E. A., Weisberg, E., Statistician, I. S. and Fraser, I. S. (1996), A comparative study of safety and efficacy of continuous low dose oestradiol released from a vaginal ring compared with conjugated equine oestrogen vaginal cream in the treatment of postmenopausal urogenital atrophy. BJOG: An International Journal of Obstetrics & Gynaecology, 103: 351–358. doi: 10.1111/j.1471-0528.1996.tb09741.x
Publication History
- Issue published online: 19 AUG 2005
- Article first published online: 19 AUG 2005
- Received 18 April 1995 Returned for Revision 26 July 1995 Revised Manuscript Received 19 September 1995 Accepted 23 October 1995
- Abstract
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Objective To compare the safety, efficacy and acceptability of a continuous low dose oestradiol releasing vaginal ring with conjugated equine oestrogen vaginal cream in the treatment of postmenopausal urogenital atrophy.
Design An open, parallel, comparative multicentre trial.
Setting Sydney and Melbourne, Australia.
Participants and Interventions One hundred and ninety-four postmenopausal women with symptoms and signs of urogenital atrophy were randomised on a 2:1 basis to 12 weeks of treatment with an oestrogen vaginal ring versus an oestrogen cream.
Main outcome measures and results Equivalence (95% CI) was demonstrated between the two treatments for relief of vaginal dryness and dyspareunia, resolution of atrophic signs, improvement in vaginal mucosal maturation indices and reduction in vaginal pH. No significant difference was demonstrated in endometrial response to a progestogen challenge test and equivalence was demonstrated in the incidence of intercurrent bleeding episodes. The vaginal ring was significantly more acceptable than the cream (P < 0.0001), and was preferred to the cream (P < 0.001).
Conclusion With equivalent efficacy and safety and superior acceptability to vaginal cream, the low dose oestradiol vaginal ring is an advance in vaginal delivery systems for the treatment of urogenital atrophy.