Clinical Research
Clinical observation of combined oral contraceptives drospirenone and ethinylestradiol tablets (Ⅱ) in the treatment of dysmenorrhea in Chinese women
Li Xiaoyu, Qian Fangbo, He Yaojuan, Zhang Xuesong, Zhang Yishan, Hou Chengzhen, Di Wen, Gu Xiangying
Published 2021-10-25
Cite as Chin J Obstet Gynecol, 2021, 56(10): 684-690. DOI: 10.3760/cma.j.cn112141-20210719-00385
Abstract
ObjectiveTo evaluate the efficacy and safety of drospirenone and ethinylestradiol tablets (Ⅱ) in Chinese women with dysmenorrhea.
MethodsThis 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.
ResultsAfter 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.
ConclusionDrospirenone and ethinylestradiol tablets (Ⅱ) is effective for the treatment of dysmenorrhea and has good safety.
Key words:
Dysmenorrhea; Contraceptives, oral, combined; Ethinyl estradiol; Androstenes; Treatment outcome; Clinical study; Drospirenone
Contributor Information
Li Xiaoyu
Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, Tianjin 300052, China
Qian Fangbo
Department of Obstetrics and Gynecology, Wuxi Maternal and Child Health Hospital, Nanjing Medical University, Wuxi 214001, China
He Yaojuan
Department of Obstetrics and Gynecology, Guangzhou Women and Children′s Medical Center, Guangzhou 510623, China
Zhang Xuesong
Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, Tianjin 300052, China
Zhang Yishan
Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, Tianjin 300052, China
Hou Chengzhen
Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, Tianjin 300052, China
Di Wen
Department of Obstetrics and Gynecology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
Gu Xiangying
Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, Tianjin 300052, China
