PMID- 30461337
OWN - NLM
STAT- MEDLINE
DCOM- 20200504
LR  - 20221207
IS  - 1931-843X (Electronic)
IS  - 1540-9996 (Linking)
VI  - 28
IP  - 2
DP  - 2019 Feb
TI  - Dienogest for Treatment of Endometriosis in Women: A 28-Week, Open-Label, 
      Extension Study.
PG  - 170-177
LID - 10.1089/jwh.2018.7084 [doi]
AB  - BACKGROUND: Dienogest provided significantly greater reduction in 
      endometriosis-associated pelvic pain (EAPP) than placebo in a 24-week, 
      randomized, double-blind study of Chinese women with endometriosis. The current 
      open-label extension study investigated the efficacy and safety of dienogest for 
      28 additional weeks in this population. PATIENTS AND METHODS: Women with 
      endometriosis were eligible to enroll at completion of the 24-week, 
      placebo-controlled study (n = 220). All women, regardless of prior study 
      treatment, received dienogest 2 mg once daily for up to 28 weeks. Absolute change 
      in EAPP from baseline on a 1-100 mm visual analog scale (VAS), bleeding pattern, 
      adverse events (AEs), laboratory parameters, and bone mineral density (BMD) were 
      evaluated. RESULTS: The open-label study was completed by 203 (92.3%) women. At 
      the end of open-label study, mean (SD) change from baseline in EAPP score on VAS 
      was -43.1 mm (26.54 mm) and -39.8 mm (31.15 mm) in the prior-dienogest and 
      prior-placebo groups, respectively. Other assessments confirmed that dienogest 
      maintained or enhanced efficacy after 28 weeks of additional treatment. Dienogest 
      initiation was associated with longer, but fewer, spotting/bleeding episodes. 
      Bleeding frequency and intensity decreased progressively during continued 
      treatment. Treatment-emergent AEs, generally mild or moderate, led to withdrawal 
      in 2 (0.9%) patients during the open-label study. Dienogest had no effect on BMD. 
      CONCLUSIONS: Dienogest 2 mg once daily is effective and safe in the long-term 
      management of EAPP in Chinese women with endometriosis, with progressive 
      decreases in EAPP and bleeding irregularities during continued treatment. 
      Efficacy and safety results of this study were consistent with previous studies 
      in Caucasian patients.
FAU - Yu, Qi
AU  - Yu Q
AD  - 1 Peking Union Medical College Hospital , Beijing, People's Republic of China .
FAU - Zhang, Shulan
AU  - Zhang S
AD  - 2 Department of Obstetrics and Gynecology, Shengjing Hospital of China Medical 
      University , Shenyang, People's Republic of China .
FAU - Li, Huajun
AU  - Li H
AD  - 3 Department of Obstetrics and Gynecology, Peking University Third Hospital , 
      Beijing, People's Republic of China .
FAU - Wang, Ping
AU  - Wang P
AD  - 4 Department of Gynecology, Huaxi Second Hospital , Chengdu, People's Republic of 
      China .
FAU - Zvolanek, Michal
AU  - Zvolanek M
AD  - 5 Medical Affairs, Bayer AG , Berlin, Germany .
FAU - Ren, Xiaowei
AU  - Ren X
AD  - 6 Data Sciences & Analytics, Bayer Healthcare Co. Ltd. , Beijing, People's 
      Republic of China .
FAU - Dong, Liying
AU  - Dong L
AD  - 7 Research & Development, Pharmaceuticals, Bayer AG , Berlin, Germany .
FAU - Lang, Jinghe
AU  - Lang J
AD  - 1 Peking Union Medical College Hospital , Beijing, People's Republic of China .
LA  - eng
SI  - ClinicalTrials.gov/NCT01822080
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20181121
PL  - United States
TA  - J Womens Health (Larchmt)
JT  - Journal of women's health (2002)
JID - 101159262
RN  - 0 (Hormone Antagonists)
RN  - 46M3EV8HHE (dienogest)
RN  - 6PG9VR430D (Nandrolone)
SB  - IM
MH  - Asian People/statistics & numerical data
MH  - Bone Density/drug effects
MH  - China/epidemiology
MH  - Double-Blind Method
MH  - Endometriosis/*drug therapy/epidemiology
MH  - Female
MH  - Hormone Antagonists/*therapeutic use
MH  - Humans
MH  - Nandrolone/analogs & derivatives/therapeutic use
MH  - Pain Measurement
MH  - Pelvic Pain/*drug therapy/epidemiology
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Chinese women
OT  - dienogest
OT  - endometriosis
OT  - open-label study
EDAT- 2018/11/22 06:00
MHDA- 2020/05/06 06:00
CRDT- 2018/11/22 06:00
PHST- 2018/11/22 06:00 [pubmed]
PHST- 2020/05/06 06:00 [medline]
PHST- 2018/11/22 06:00 [entrez]
AID - 10.1089/jwh.2018.7084 [doi]
PST - ppublish
SO  - J Womens Health (Larchmt). 2019 Feb;28(2):170-177. doi: 10.1089/jwh.2018.7084. 
      Epub 2018 Nov 21.