Dienogest for Treatment of Endometriosis in Chinese Women: A Placebo-Controlled, Randomized, Double-Blind Phase 3 Study

Jinghe Lang, Lang J, Qi Yu, Shulan Zhang, Zhang S, Li H, Huajun Li, Kerstin Gude, Gude K, Christiane von Ludwig, Christiane Ludwig, von Ludwig C, Xiaowei Ren, Ren X, Dong L, Liying Dong
Journal of women's health (2002) · 2017 · vol. 27(2) , pp. 148–155 · doi:10.1089/jwh.2017.6399 · PMID:29083258 · W2766765174
RCT OA: closed CC0 ⤵ 44 in-corpus citations
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Dienogest 2 mg daily for 24 weeks significantly reduced endometriosis-associated pelvic pain in Chinese women compared to placebo, with a favorable safety profile and no impact on bone mineral density.

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Abstract

BACKGROUND: Dienogest is a progestin with demonstrated efficacy in the treatment of endometriosis in European women. The objective of this study was to evaluate the efficacy and safety of dienogest in Chinese women. PATIENTS AND METHODS: This 24-week, randomized, double-blind, placebo-controlled multicenter (n = 23) study evaluated the efficacy and safety of 2 mg dienogest once daily in 255 Chinese women aged 18-45 years with laparoscopically diagnosed endometriosis and an endometriosis-associated pelvic pain (EAPP) score ≥30 mm on a 0-100 mm visual analog scale. The primary efficacy variable was absolute change in EAPP from baseline to week 24. Secondary efficacy variables included proportions of responders and intake of supportive analgesic medication. Safety variables included adverse events (AEs), laboratory parameters, and bleeding patterns. Bone mineral density (BMD) was evaluated in a subset of 140 women. RESULTS: After 24 weeks of treatment, the difference between treatment arms for mean reduction in EAPP was statistically significant in favor of dienogest (-24.54 mm; 95% CI -29.93 to -19.15; p < 0.0001). Secondary efficacy analyses supported the significant superiority of dienogest over placebo. Dienogest was well tolerated, with few AEs associated with therapy. Dienogest had no effect on BMD levels after 24 weeks of treatment. CONCLUSIONS: Dienogest 2 mg once daily for 24 weeks was superior to placebo in reducing EAPP and was safe and well tolerated in Chinese women with endometriosis. The results are consistent with studies previously conducted in European women.

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Condition tags

endometriosischronic_pelvic_pain

MeSH descriptors

Endometriosis Nandrolone Pelvic Pain Progestins Adolescent Adolescent Adult Adult Asian People Asian People Bone Density Bone Density Bone Density China China China Double-Blind Method Double-Blind Method Endometriosis Endometriosis

Citation neighborhood (2-hop)

Papers in the corpus that this work cites (lower rings, blue) and that cite this one (upper rings, green). Dot size scales with the paper's in-corpus citation count — bigger dot = more influential within the endo/adeno field. Click a dot to open that paper. Outer rings show 2-hop neighbours — papers reached through the immediate citers/citees. [ collapse to 1-hop ]

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Cited by (48)

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