title: [Evaluation the efficacy and safety of estradiol and drospirenone tablets in the treatment of menopausal symptoms among postmenopausal Chinese healthy women:a randomized, multi-center, double-blind, placebo-controlled clinical study].
abstract: OBJECTIVE
  To study the efficacy and safety of estradiol and drospirenone tablets (Angeliq) in treatment of menopausal symptoms among postmenopausal Chinese healthy women.
  
  
  METHODS
  Total 244 postmenopausal Chinese healthy women who had moderate to severe hot flushes were randomly assigned into estradiol and drospirenone (observation group, n = 183) or placebo group (n = 61) by the ratio of 3:1 for 16 weeks in this randomized multi-center double-blind placebo-controlled study. During the trial, the follow-up visits were conducted at week 4, 8, 12, 16 of treatment and 2 weeks after treatment respectively. Height, weight, vital signs, hot flushes, other relevant menopausal symptoms and vaginal bleeding were observed in each follow-up visit, while the clinical global impression scale was assessed at 16 weeks as well.
  
  
  RESULTS
  It showed that hot flushes were reduced significantly more in observation group than that in placebo group (P < 0.01), although both treatments were effective. The absolute values of mean severity index of total hot flushes decreased by -0.6 ± 0.5 in observation group and -0.4 ± 0.4 in placebo group from baseline respectively, which reached significant difference (P < 0.05). However, the absolute values of mean severity index of moderate to severe hot flushes decreased by -0.6 ± 0.8 in observation group and -0.3 ± 0.6 in placebo group from baseline respectively, which had no significant difference (P > 0.05). After 16 weeks treatment, it also showed that estradiol and drospirenone had significant better efficacy than placebo on moderate to severe sweating, vaginal dryness and clinical global impression scale (P < 0.01). During the trial, blood pressure in observation group was stable. The rate of vaginal bleeding in observation group was higher than that in the placebo group, especially during the week 4 to week 8 when 48.9% (87/178) in observation group and 10.7% (6/56) in placebo group of patients bled. Although the cumulative amenorrhea rate of observation group was lower than that of placebo group in each cycle (28 days), it increased gradually along with duration of the treatment. The commonest adverse event in observation group was breast tenderness which accounted for 12.0% (22/183). The level of serum potassium was in the normal range in observation group mostly.Meanwhile, the other adverse events rate was low. Serious adverse events reported in this trial were assessed as not study drug related or as unlikely study drug related.
  
  
  CONCLUSIONS
  Estradiol and drospirenone tablets which could effectively alleviate menopausal symptoms in postmenopausal Chinese healthy women is a novel hormone replacement therapy regimen with high safety and efficacy.
authors: Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
authors: Yuan-zheng
authors: YZ
authors: Zhou
authors: Li-zhou
authors: LZ
authors: Sun
authors: Jin-fang
authors: JF
authors: Lin
authors: Xin
authors: X
authors: Yang
authors: Li-jia
authors: LJ
authors: Zhang
authors: Jie
authors: J
authors: Qiao
authors: Ze-hua
authors: ZH
authors: Wang
authors: Yan-xue
authors: YX
authors: Xu
authors: Zheng-ai
authors: ZA
authors: Xiong
authors: Shou-qing
authors: SQ
authors: Lin
mesh_terms: D000368:Aged; D000736:Androstenes / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D002681:China; D004311:Double-Blind Method; D004958:Estradiol / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D015914:Estrogen Replacement Therapy; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D017698:Postmenopause; D013607:Tablets; D016896:Treatment Outcome; D014623:Vaginal Diseases / Q000188:drug therapy
chemical_list: D000736:Androstenes; D000451:Mineralocorticoid Receptor Antagonists; D013607:Tablets; D004958:Estradiol; C035144:drospirenone