Clinical observation of combined oral contraceptives drospirenone and ethinylestradiol tablets (Ⅱ) in the treatment of dysmenorrhea in Chinese women
10.3760/cma.j.cn112141-20210719-00385
- VernacularTitle:屈螺酮炔雌醇片(Ⅱ)治疗痛经的疗效与安全性
- Author:
Xiaoyu LI
1
;
Fangbo QIAN
;
Yaojuan HE
;
Xuesong ZHANG
;
Yishan ZHANG
;
Chengzhen HOU
;
Wen DI
;
Xiangying GU
Author Information
1. 天津医科大学总医院妇产科 300052
- Keywords:
Dysmenorrhea;
Contraceptives, oral, combined;
Ethinyl estradiol;
Androstenes;
Treatment outcome;
Clinical study;
Drospirenone
- From:
Chinese Journal of Obstetrics and Gynecology
2021;56(10):684-690
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of drospirenone and ethinylestradiol tablets (Ⅱ) in Chinese women with dysmenorrhea.Methods:This was a single-arm, open-label, interventional, multicenter, post-authorization safety/effectiveness study of drospirenone and ethinylestradiol tablets (Ⅱ) across 6 treatment cycles, a total of 526 patients were included in the dysmenorrhea subgroup. Visual analog scale (VAS) was used to assess the severity of menstrual pain. Secondary outcomes included unintended pregnancies, bleeding pattern, cycle control and safety.Results:After treated with drospirenone and ethinylestradiol tablets (Ⅱ), VAS of pain had decreased significantly compared with baselines [(49.5±23.7) vs (32.3±24.9) vs (20.7±19.4) vs (18.4±18.7) mm, P<0.01]. From the second cycle to the fifth cycle, the incidence of scheduled bleeding increased from 93.9% (450/479) to 96.4% (431/447). The duration of scheduled bleeding decreased from (5.7±2.7) to (5.4±1.8) days. The incidence of intermenstrual bleeding decreased from 9.0% (43/479) to 5.6% (25/447). 17.5% (92/526) patients reported adverse drug reactions, most frequently reported adverse events were breast pain, nausea, breast swelling, headache, and uterine bleeding. No death occurred during the study. Conclusion:Drospirenone and ethinylestradiol tablets (Ⅱ) is effective for the treatment of dysmenorrhea and has good safety.
