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[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].
Zhonghua Fu Chan Ke Za Zhi. 2011 May; 46(5):345-9.ZF

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.

CONCLUSION

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+Show Affiliations

Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

English Abstract
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

chi

PubMed ID

21733370

Citation

Zhou, Yuan-zheng, et al. "[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]." Zhonghua Fu Chan Ke Za Zhi, vol. 46, no. 5, 2011, pp. 345-9.
Zhou YZ, Sun LZ, Lin JF, et al. [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]. Zhonghua Fu Chan Ke Za Zhi. 2011;46(5):345-9.
Zhou, Y. Z., Sun, L. Z., Lin, J. F., Yang, X., Zhang, L. J., Qiao, J., Wang, Z. H., Xu, Y. X., Xiong, Z. A., & Lin, S. Q. (2011). [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]. Zhonghua Fu Chan Ke Za Zhi, 46(5), 345-9.
Zhou YZ, et al. [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]. Zhonghua Fu Chan Ke Za Zhi. 2011;46(5):345-9. PubMed PMID: 21733370.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [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]. AU - Zhou,Yuan-zheng, AU - Sun,Li-zhou, AU - Lin,Jin-fang, AU - Yang,Xin, AU - Zhang,Li-jia, AU - Qiao,Jie, AU - Wang,Ze-hua, AU - Xu,Yan-xue, AU - Xiong,Zheng-ai, AU - Lin,Shou-qing, PY - 2011/7/8/entrez PY - 2011/7/8/pubmed PY - 2012/5/25/medline SP - 345 EP - 9 JF - Zhonghua fu chan ke za zhi JO - Zhonghua Fu Chan Ke Za Zhi VL - 46 IS - 5 N2 - 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. CONCLUSION: 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. SN - 0529-567X UR - https://www.unboundmedicine.com/medline/citation/21733370/[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]_ L2 - http://journal.yiigle.com/LinkIn.do?linkin_type=pubmed&amp;issn=0529-567X&amp;year=2011&amp;vol=46&amp;issue=5&amp;fpage=345 DB - PRIME DP - Unbound Medicine ER -