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
- 1 April 1996
- journal article
- clinical trial
- Published by Wiley in BJOG: An International Journal of Obstetrics and Gynaecology
- Vol. 103 (4) , 351-358
- https://doi.org/10.1111/j.1471-0528.1996.tb09741.x
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.Keywords
This publication has 10 references indexed in Scilit:
- The acceptability of a combined oestrogen/progestogen contraceptive vaginal ringContraception, 1995
- A comparative multicenter study of the effects of continuous low-dose estradiol released from a new vaginal ring versus estriol vaginal pessaries in postmenopausal women with symptoms and signs of urogenital atrophyAmerican Journal of Obstetrics and Gynecology, 1994
- Release of 17-Beta-Oestradiol from a Vaginal Ring in Postmenopausal Women: Pharmacokinetic EvaluationGynecologic and Obstetric Investigation, 1994
- Oestradiol-releasing vaginal ring for treatment of postmenopausal urogenital atrophyMaturitas, 1993
- Vaginal Contraceptive RingsAnnals of Medicine, 1993
- Contraceptive vaginal ring — a rising star on the contraceptive horizonAdvances in Contraception, 1990
- Vaginal rings for continuous low-dose release of oestradiol in the treatment of urogenital atrophyMaturitas, 1989
- A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailabilityJournal of Pharmacokinetics and Biopharmaceutics, 1987
- Endometrium and plasma hormone profile in the peri-menopause and post-menopauseMaturitas, 1986
- Prevalence of Genitourinary Symptoms in the Late MenopauseActa Obstetricia et Gynecologica Scandinavica, 1984