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.

Abstract

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.

• Authors: R A Ayton, G M Darling, A L Murkies, E A Farrell, E Weisberg, I Selinus, I D Fraser
• Journal: British journal of obstetrics and gynaecology (Br J Obstet Gynaecol) Vol. 103 Issue 4 Pg. 351-8 (Apr 1996) ISSN: 0306-5456 [Print] England
• PMID: 8605133 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Delayed-Action Preparations
• Estrogens
• Vaginal Creams, Foams, and Jellies
• Estradiol

Topics

• Administration, Intravaginal
• Adult
• Aged
• Aged, 80 and over
• Atrophy (drug therapy)
• Delayed-Action Preparations
• Endometrium (pathology)
• Estradiol (administration & dosage, adverse effects)
• Estrogens (administration & dosage, adverse effects)
• Female
• Humans
• Middle Aged
• Patient Satisfaction
• Postmenopause
• Uterine Hemorrhage (etiology)
• Vagina (pathology)
• Vaginal Creams, Foams, and Jellies