Effective treatment of heavy and/or prolonged menstrual bleeding with an oral contraceptive containing estradiol valerate and dienogest: a randomized, double-blind Phase III trial  

Oleh:

Fraser, I.S. ; Romer, T. ; Parke, S. ; Zeun, S.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Human Reproduction vol. 26 no. 10 (Oct. 2011), page 2698-2708.
Topik: Dienogest; Estradiol Valerate; Oral Contraceptive; Menstrual Bleeding; RCT
Fulltext: Hum. Reprod.-2011-Fraser-2698-708.pdf (284.56KB)

Ketersediaan

Perpustakaan FK Nomor Panggil: H07.K.2011.02 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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BACKGROUND This double-blind trial investigated the efficacy and safety of estradiol valerate/dienogest (E2V/DNG) for the treatment of heavy menstrual bleeding without recognizable organic pathology. METHODS Otherwise healthy women with idiopathic heavy, prolonged or frequent menstrual bleeding, confirmed during a 90-day run-in phase, were randomized (2:1) according to a permuted-block, computer-generated schedule to E2V/DNG or placebo for 196 days at 34 centres in Europe and Australia. The primary efficacy end-point was the proportion of women with a ‘complete’ response (i.e. a return to ‘menstrual normality’) during a 90-day efficacy phase. Secondary end-points included changes in measured menstrual blood loss (MBL) and iron metabolism parameters. RESULTS The intention-to-treat population comprised 231 women. The E2V/DNG response rate was much higher than with placebo (P < 0.0001). The mean reduction in MBL volume in E2V/DNG recipients was 69.4% (median 79.2%) versus 5.8% (median 7.4%) in placebo recipients. The between-treatment difference in MBL volume was 373 ml in favour of E2V/DNG (95% confidence interval 490, 255 ml; P < 0.0001). Significant improvements in iron metabolism parameters were observed with E2V/DNG but not placebo. Overall, 14 women (9.7%) treated with E2V/DNG and 5 (6.2%) treated with placebo prematurely discontinued treatment because of adverse events, headache being the most prevalent. Serious adverse events occurred in both the E2V/DNG and placebo groups (each n = 2). CONCLUSIONS E2V/DNG is an effective treatment in women with heavy and/or prolonged menstrual bleeding without organic pathology. Further study of E2V/DNG compared with an active comparator is warranted.

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