PMID- 29083258
OWN - NLM
STAT- MEDLINE
DCOM- 20180813
LR  - 20221207
IS  - 1931-843X (Electronic)
IS  - 1540-9996 (Linking)
VI  - 27
IP  - 2
DP  - 2018 Feb
TI  - Dienogest for Treatment of Endometriosis in Chinese Women: A Placebo-Controlled, 
      Randomized, Double-Blind Phase 3 Study.
PG  - 148-155
LID - 10.1089/jwh.2017.6399 [doi]
AB  - 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.
FAU - Lang, Jinghe
AU  - Lang J
AD  - 1 Department of Obstetrics and Gynecology, Peking Union Medical College Hospital 
      , Beijing, China .
FAU - Yu, Qi
AU  - Yu Q
AD  - 1 Department of Obstetrics and Gynecology, Peking Union Medical College Hospital 
      , Beijing, China .
FAU - Zhang, Shulan
AU  - Zhang S
AD  - 2 Department of Gynecology and Obstetrics, China Medical University Shengjing 
      Hospital , Shenyang, China .
FAU - Li, Huajun
AU  - Li H
AD  - 3 Department of Obstetrics and Gynecology, China-Japan Friendship Hospital , 
      Beijing, China .
FAU - Gude, Kerstin
AU  - Gude K
AD  - 4 Medical Affairs Women's Healthcare , Gynecological Therapy, Bayer AG, Berlin, 
      Germany .
FAU - von Ludwig, Christiane
AU  - von Ludwig C
AD  - 4 Medical Affairs Women's Healthcare , Gynecological Therapy, Bayer AG, Berlin, 
      Germany .
FAU - Ren, Xiaowei
AU  - Ren X
AD  - 5 Data Sciences & Analytics, Bayer Healthcare Co. Ltd. , Beijing, China .
FAU - Dong, Liying
AU  - Dong L
AD  - 6 Clinical Development Gynecological Therapies , Division of Pharmaceuticals, 
      Bayer AG, Berlin, Germany .
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20171030
PL  - United States
TA  - J Womens Health (Larchmt)
JT  - Journal of women's health (2002)
JID - 101159262
RN  - 0 (Progestins)
RN  - 46M3EV8HHE (dienogest)
RN  - 6PG9VR430D (Nandrolone)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Asian People
MH  - Bone Density/drug effects
MH  - China/epidemiology
MH  - Double-Blind Method
MH  - Endometriosis/diagnosis/*drug therapy/ethnology
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Nandrolone/*analogs & derivatives/therapeutic use
MH  - Pain Measurement
MH  - Pelvic Pain/drug therapy/*etiology
MH  - Progestins/*therapeutic use
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Chinese women
OT  - dienogest
OT  - endometriosis
OT  - pelvic pain
OT  - randomized controlled trial
OT  - visual analog scale
EDAT- 2017/10/31 06:00
MHDA- 2018/08/14 06:00
CRDT- 2017/10/31 06:00
PHST- 2017/10/31 06:00 [pubmed]
PHST- 2018/08/14 06:00 [medline]
PHST- 2017/10/31 06:00 [entrez]
AID - 10.1089/jwh.2017.6399 [doi]
PST - ppublish
SO  - J Womens Health (Larchmt). 2018 Feb;27(2):148-155. doi: 10.1089/jwh.2017.6399. 
      Epub 2017 Oct 30.