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

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收录情况: ◇ SCIE ◇ SSCI

单位: [1]Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing, China [2]Department of Gynecology and Obstetrics, China Medical University Shengjing Hospital, Shenyang, China [3]Department of Obstetrics and Gynecology, China-Japan Friendship Hospital, Beijing, China [4]Medical Affairs Women’s Healthcare, Gynecological Therapy, Bayer AG, Berlin, Germany [5]Data Sciences & Analytics, Bayer Healthcare Co.Ltd.,Beijing, China [6]Clinical Development Gynecological Therapies, Division of Pharmaceuticals, Bayer AG, Berlin, Germany
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关键词: Chinese women dienogest endometriosis pelvic pain randomized controlled trial visual analog scale

摘要:
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 2mg dienogest once daily in 255 Chinese women aged 18-45 years with laparoscopically diagnosed endometriosis and an endometriosis-associated pelvic pain (EAPP) score 30mm on a 0-100mm 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 (-24.54mm; 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 2mg 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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出版当年[2017]版:
大类 | 3 区 医学
小类 | 3 区 医学:内科 3 区 妇产科学 3 区 公共卫生、环境卫生与职业卫生
最新[2025]版:
大类 | 3 区 医学
小类 | 3 区 医学:内科 3 区 妇产科学 3 区 公共卫生、环境卫生与职业卫生 3 区 女性研究
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出版当年[2016]版:
Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Q1 WOMENS STUDIES Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Q2 OBSTETRICS & GYNECOLOGY Q2 MEDICINE, GENERAL & INTERNAL
最新[2023]版:
Q1 MEDICINE, GENERAL & INTERNAL Q1 OBSTETRICS & GYNECOLOGY Q1 WOMENS STUDIES Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2016版] 出版当年五年平均[2012-2016] 出版前一年[2015版] 出版后一年[2017版]

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第一作者单位: [1]Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing, China
通讯作者:
通讯机构: [6]Clinical Development Gynecological Therapies, Division of Pharmaceuticals, Bayer AG, Berlin, Germany [*1]Clinical Development Gynecological Therapies Division of Pharmaceuticals Bayer AG Mueller Street 178 Berlin 13353 Germany
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