Local treatment of urogenital atrophy with an estradiol-releasing vaginal ring: A comparative and a placebo-controlled multicenter study

被引：66

作者：

Casper F. ^{[1
,4
]}

Petri E. ^{[2
,3
]}

Almendral C.

Casper F. ^{[1
,4
]}

Distler W.

Frick J.

Herold J.

Huenges P.

Hussong R.

Methfessel H.D.

Müller M.

Petri E. ^{[2
,3
]}

Retzke U.

Santellani M.

Weise W.

Wilhelm H.

Wortmann M.

Zimber P.

机构：

[1] Dept. of Obstetrics and Gynecology, University of Mainz

[2] Dept. of Obstetrics and Gynecology, Schwerin

[3] Teaching Hospital, University of Rostock

[4] Dept. of Obstetrics and Gynecology, University of Mainz, Mainz

来源：

International Urogynecology Journal | 1999年 / 10卷 / 3期

关键词：

Estradiol; Local estriol therapy; Urogenital atrophy; Vaginal ring;

D O I：

10.1007/s001920050040

中图分类号：

学科分类号：

摘要：

Local estrogen substitution has been shown to be more appropriate than any systemic application for the treatment of urogenital symptoms of hormone defiency. The efficacy, safety and acceptability of a new low-dose drug delivery system consisting of an estradiol-releasing silicone vaginal ring was studied in two multicenter trials. In an open-label comparative trial a total of 219 postmenopausal women were randomized to the estradiol-releasing vaginal ring or to estriol suppositories. In terms of efficacy both treatment arms were shown to be equivalent; however, significantly higher rates of acceptability were found for the vaginal ring. In a double-blinded placebo-controlled study a total of 84 patients were randomized to either treatment arm for a period of 24 weeks. The statistically significant improvement of the vaginal epithelial pH and maturation values demonstrated the efficacy of the estradiol-releasing vaginal ring compared to the placebo ring.

引用

页码：171 / 176

页数：5

共 15 条

[1]

Contraception: Workshop Proceedings, 24, pp. 321-491, (1981)

[2]

Englund D.E., Victor A., Johansson E.D.B., Pharmacokinetics and pharmacodynamic effects of vaginal oestradiol administration from silastic rings in postmenopausal women, Maturitas, 3, pp. 125-133, (1981)

[3]

Stumpf P., Maruca G., Santen R., Et al., Development of a vaginal ring for achieving physiological levels of 17 β-estradiol in hypoestrogenic women, J Clin Endocrinol Metab, 54, pp. 208-210, (1982)

[4]

Veldhuis J., Samojlik E., Evans W., Endocrine impact of pure estradiol replacement in postmenopausal women: Alterations in anterior pituitary hormone release and circulating sex steroid hormone concentrations, Am J Obstet Gynecol, 155, pp. 334-339, (1986)

[5]

Holmgren P.A., Lindskog M., Von Schoultz B., Vaginal rings for continuous low-dose release of oestradiol in the treatment of urogenital atrophy, Maturitas, 11, pp. 55-63, (1989)

[6]

Smith P., Heimer G., Lindskog M., Et al., Oestradiol-releasing vaginal ring for treatment of postmenopausal urogenital atrophy, Maturitas, 16, pp. 145-154, (1993)

[7]

Hustin J., Van Den Eynde J.P., Cytologic evaluation of the effect of various estrogens given in postmenopause, Acta Cytol, 21, pp. 225-228, (1977)

[8]

Barlow D.H., Cardozo L.D., Francis R.M., Et al., Urogenital ageing and its effect on sexual health in older British women, Br J Obstet Gynaecol, 104, pp. 87-91, (1997)

[9]

Iosif C.S., Bekassy Z., Prevalence of genito-urinary symptoms in the late menopause, Acta Obstet Gynecol Scand, 63, pp. 257-260, (1984)

[10]

Iosif C.S., Batra S.C., Ek A., Et al., Estrogen receptors in the human female lower urinary tract, Am J Obstet Gynecol, 141, pp. 817-820, (1981)

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