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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.
Br J Obstet Gynaecol. 1996 Apr; 103(4):351-8.BJ

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+Show Affiliations

Menopause Service, Division of Gynaecology, Royal Women's Hospital, Melbourne, Australia.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

8605133

Citation

Ayton, R A., et al. "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." British Journal of Obstetrics and Gynaecology, vol. 103, no. 4, 1996, pp. 351-8.
Ayton RA, Darling GM, Murkies AL, et al. 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. Br J Obstet Gynaecol. 1996;103(4):351-8.
Ayton, R. A., Darling, G. M., Murkies, A. L., Farrell, E. A., Weisberg, E., Selinus, I., & Fraser, I. D. (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. British Journal of Obstetrics and Gynaecology, 103(4), 351-8.
Ayton RA, et al. 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. Br J Obstet Gynaecol. 1996;103(4):351-8. PubMed PMID: 8605133.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Ayton,R A, AU - Darling,G M, AU - Murkies,A L, AU - Farrell,E A, AU - Weisberg,E, AU - Selinus,I, AU - Fraser,I D, PY - 1996/4/1/pubmed PY - 1996/4/1/medline PY - 1996/4/1/entrez SP - 351 EP - 8 JF - British journal of obstetrics and gynaecology JO - Br J Obstet Gynaecol VL - 103 IS - 4 N2 - 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. SN - 0306-5456 UR - https://www.unboundmedicine.com/medline/citation/8605133/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_ L2 - https://www.lens.org/lens/search?q=citation_id:8605133 DB - PRIME DP - Unbound Medicine ER -