title: [Efficacy and safety of a combined oral contraceptive containing drospirenone 3 mg and ethinylestradiol 20 µg in a 24+4-day regimen in China].
abstract: OBJECTIVE
  To assess the efficacy, bleeding pattern, cycle control and safety of a combined oral contraceptive (YAZ) containing drospirenone 3 mg and ethinylestradiol 20 µg in a 24+4-day regimen in China.
  
  
  METHODS
  This is a multi-center, open, one-label study. Healthy females aged 18-45 years received YAZ for 13 cycles. Following-ups were scheduled during the treatment phase on Day 12-19 of Cycle 1, 4, 7 and 10 and 10-17 days after completing the study. The efficacy variables were the number of unintended pregnancies, bleeding pattern and cycle control. The safety variables were adverse events (AE), lab examinations, physical and gynecological examinations, vital signs and body weights and questionnaires.
  
  
  RESULTS
  Four pregnancies occurred among 675 women for 603.78 women-years, resulting in a Pearl index (PI) of 0.7 and adjusted PI of 0.6. The cumulative 1-year pregnancy rate was 0.66%. The mean number of bleeding/spotting days was (26.3 ± 12.4) days in reference period 1 and (15.4 ± 5.5) days in reference period 4. 94.2% (582/618)- 96.8% (538/558) subjects experienced scheduled bleeding. The mean duration of scheduled bleeding decreased from (5.9 ± 3.2) to (5.0 ± 1.6) days. The percentage of women with intermenstrual bleeding decreased from 14.5% (90/621) at Cycle 1 to 2.3% (13/558) at Cycle 12. The common AE relating treatment include nausea (3.4%, 23/675), breast tenderness (1.2%, 8/675), dizzy (1.2%), vagina bleeding (1.2%). No serious AE relating treatment occurred. 85.6% (542/633) subjects were satisfied or very satisfied with the study treatment.
  
  
  CONCLUSIONS
  YAZ is highly effective, acceptable and safe for Chinese women.
authors.affiliation: Department of Family Planning, Obstetrics and Gynecology Hospital, Fudan University, Shanghai 200011, China.
authors.forename: Wang
authors.initials: W
authors.lastname: Caiyan
authors.forename: Di
authors.initials: D
authors.lastname: Wen
authors.forename: Liao
authors.initials: L
authors.lastname: Qinping
authors.forename: Shen
authors.initials: S
authors.lastname: Huan
authors.forename: Han
authors.initials: H
authors.lastname: Ziyan
authors.forename: Tang
authors.initials: T
authors.lastname: Liangdan
authors.forename: Xiong
authors.initials: X
authors.lastname: Zheng'ai
authors.forename: Li
authors.initials: L
authors.lastname: Yufeng
authors.forename: Zhang
authors.initials: Z
authors.lastname: Shulan
authors.forename: Dong
authors.initials: D
authors.lastname: Baihua
authors.forename: Xin
authors.initials: X
authors.lastname: Xiaoyan
authors.forename: Ren
authors.initials: R
authors.lastname: Mulan
authors.forename: Li
authors.initials: L
authors.lastname: Xiaomao
authors.forename: Xu
authors.initials: X
authors.lastname: Youdi
authors.forename: Ma
authors.initials: M
authors.lastname: Zhisong
authors.forename: Xie
authors.initials: X
authors.lastname: Meiqing
authors.forename: Wu
authors.initials: W
authors.lastname: Hongyu
authors.affiliation: Email: zirong1130@hotmail.com.
authors.forename: Huang
authors.initials: H
authors.lastname: Zirong
mesh_terms: D000293:Adolescent; D000328:Adult; D000736:Androstenes / Q000008:administration & dosage* / Q000009:adverse effects; D001835:Body Weight; D002681:China; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004967:Estrogens / Q000008:administration & dosage* / Q000009:adverse effects; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects*; D008598:Menstruation / Q000187:drug effects*; D000451:Mineralocorticoid Receptor Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D011247:Pregnancy; D018873:Pregnancy Rate; D016896:Treatment Outcome; D014592:Uterine Hemorrhage / Q000139:chemically induced; D055815:Young Adult
chemical_list: D000736:Androstenes; D003277:Contraceptives, Oral, Combined; D004967:Estrogens; D000451:Mineralocorticoid Receptor Antagonists; D004997:Ethinyl Estradiol; C035144:drospirenone