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Abstract
The treatment of postmenopausal symptoms was studied in 26 healthy women using a new
synthetic rubber (Kraton D 2109) vaginal ring containing 53 mg of 17β-oestradiol.
All women were postmenopausal, at least 6 months after the last vaginal bleeding and
suffering from daily hot flushes. The study was conducted in a double-blind placebo-controlled
intrapatient cross-over fashion, and the study period was 6 months. The rings used
give an initial in vitro release rate of 0.4 mg/E2 per day. The in vitro release rate decreases to about 0.2 mg/day after 20 days and
levels off asymptotically to about 0.1 mg/day after 50 days. Serum E2 levels equivalent to the follicular phase of the normal menstrual cycle were measured
after 1 month's use, and serum E2 level stayed above postmenopausal levels throughout the study period. FSH was suppressed
during use of the E2-releasing vaginal ring, while LH showed no statistically significant suppression
in continued use. Postmenopausal complaints were recorded by Visual Analogue Scales
(VAS) as judged by both the patient and the examining doctor; all complaints had favourable
outcomes during use of the E2-releasing vaginal ring without deterioration of symptoms during use of the placebo
ring. No serious side-effects were encountered, and the possibility of managing all
postmenopausal complaints with intravaginal oestrogen treatment is discussed.
Keywords
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Article info
Publication history
Accepted:
December 9,
1992
Received in revised form:
December 7,
1992
Received:
September 2,
1992
Identification
Copyright
© 1993 Published by Elsevier Inc.