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Endometrial safety of a transdermal sequential estradiol-levonorgestrel combination.

Author(s): Sturdee DW, van de Weijer P, von Holst T

Affiliation(s): Department of Obstetrics and Gynaecology, Birmingham Heartlands and Solihull NHS Trust, Solihull Hospital, Lode Lane, Solihull, West Midlands B91 2JL, UK.

Publication date & source: 2002-06, Climacteric., 5(2):170-7.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

OBJECTIVE: The aim of this 1-year, randomized, multinational, open-label study was to assess the effect on the endometrium of three dosages of estradiol and sequential levonorgestrel, each administered in a novel 7-day transdermal matrix patch. METHODS: A total of 468 postmenopausal women received patches of 15 cm2 (50 micrograms/day estradiol for 2 weeks followed by 50 micrograms/day estradiol-10 micrograms/day levonorgestrel for 2 weeks), 22.5 cm2 (75 micrograms/day estradiol for 2 weeks followed by 75 micrograms/day estradiol-15 micrograms/day levonorgestrel for 2 weeks) or 30 cm2 (100 micrograms/day estradiol for 2 weeks followed by 100 micrograms/day estradiol-20 micrograms/day levonorgestrel for 2 weeks). Each patch was applied for 7 days. RESULTS: Endometrial biopsies were taken before and after 1 year of treatment, with final valid biopsy results being obtained in 399 women. There were two cases of endometrial hyperplasia (one in the 22.5-cm2 and one in the 30-cm2 group). All three doses of this 7-day sequential combined estradiol-levonorgestrel transdermal hormone replacement therapy therefore had excellent endometrial safety. The lowest dose, however, was associated with less bleeding and a somewhat different histological pattern, compared with the two higher doses. All three doses provided a high level of patient satisfaction with the bleeding response. CONCLUSION: Estradiol and sequential levonorgestrel administered in a 7-day transdermal matrix patch for 1 year provide endometrial protection.

Page last updated: 2006-01-31

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