title: Efficacy and safety of the contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive in Chinese women: a 1-year randomised trial.
abstract: OBJECTIVE
  The aim of the study was to assess the efficacy and tolerability of the monthly vaginal ring (NuvaRing; 15 μg ethinylestradiol [EE] and 120 μg etonogestrel per day) compared with a monophasic (21/7) combined oral contraceptive (COC) containing 30 μg EE and 3 mg drospirenone in healthy Chinese women aged 18-40 years.
  
  
  METHODS
  This was a phase III, open-label, randomised multicentre trial conducted in China. Participants received NuvaRing or COC for 13 cycles (3 weeks of ring/pill treatment followed by a 1-week ring-free/pill-free period). Contraceptive efficacy was assessed by in-treatment pregnancies and expressed by the Pearl Index (PI; number of pregnancies/100 woman-years of use). Cycle control was assessed by unscheduled (breakthrough) and absence of scheduled (withdrawal) bleeding events. Safety and tolerability were assessed throughout the study.
  
  
  RESULTS
  Participants were randomised either to the NuvaRing (n = 732) or to the COC (n = 214); 588 (82.4%) and 182 (78.4%) participants, respectively, completed the study. There were 10 in-treatment pregnancies in the NuvaRing group (PI 1.92; 95% confidence interval [CI] 0.92, 3.53) and five in the COC group (PI 3.12; 95% CI 1.01, 7.29). Breakthrough bleeding/spotting ranged from 18.6% (Cycle 1) to 4.2% (Cycle 11) for NuvaRing and from 21.6% (Cycle 1) to 7.9% (Cycle 11) for COC. Absence of withdrawal bleeding ranged from 8.6% (Cycle 1) to 3.0% (Cycle 11) for NuvaRing and from 14.6% (Cycle 1) to 6.4% (Cycle 5) for COC. For NuvaRing and COC, respectively, 26.6% and 25.0% of participants had treatment-related adverse events, and 7.0% and 9.1% discontinued the study as a result.
  
  
  CONCLUSIONS
  Once-monthly NuvaRing is efficacious and safe for use in Chinese women.
authors.affiliation: a Peking Union Medical College Hospital , Beijing , China ;
authors.forename: Guang Sheng
authors.initials: GS
authors.lastname: Fan
authors.affiliation: b Zhongda Hospital, Southeast University , Nanjing , China ;
authors.forename: Mulan
authors.initials: M
authors.lastname: Ren
authors.affiliation: c Department of Obstetrics and Gynecology , Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University , Shanghai , China ;
authors.forename: Wen
authors.initials: W
authors.lastname: Di
authors.affiliation: d Family Planning Research Institute of Tongji Medical College of Huazhong University of Science and Technology , Wuhan , China ;
authors.forename: Ping
authors.initials: P
authors.lastname: Su
authors.affiliation: e Southwest Hospital, Third Military Medical University, Obstetrics and Gynecology , Chongqing , China ;
authors.forename: Qin
authors.initials: Q
authors.lastname: Chang
authors.affiliation: f Peking University Third Hospital , Beijing , China ;
authors.forename: Shuying
authors.initials: S
authors.lastname: Wu
authors.affiliation: g Merck & Co., Inc. , Kenilworth , NJ , USA.
authors.forename: Yun
authors.initials: Y
authors.lastname: Qin
authors.affiliation: g Merck & Co., Inc. , Kenilworth , NJ , USA.
authors.forename: Tjeerd
authors.initials: T
authors.lastname: Korver
authors.affiliation: g Merck & Co., Inc. , Kenilworth , NJ , USA.
authors.forename: Maya
authors.initials: M
authors.lastname: Marintcheva-Petrova
authors.affiliation: g Merck & Co., Inc. , Kenilworth , NJ , USA.
authors.forename: Carol
authors.initials: C
authors.lastname: Yacik
authors.affiliation: g Merck & Co., Inc. , Kenilworth , NJ , USA.
authors.forename: Christine
authors.initials: C
authors.lastname: McCrary Sisk
authors.affiliation: g Merck & Co., Inc. , Kenilworth , NJ , USA.
authors.forename: Guoqin
authors.initials: G
authors.lastname: Wang
mesh_terms: D000293:Adolescent; D000328:Adult; D002681:China; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017135:Desogestrel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004338:Drug Combinations; D004412:Dysmenorrhea / Q000139:chemically induced; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D055118:Medication Adherence; D008796:Metrorrhagia / Q000139:chemically induced; D055815:Young Adult
chemical_list: D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; C516519:NuvaRing; C044815:etonogestrel; D004997:Ethinyl Estradiol; D017135:Desogestrel
keywords: Compliance; NuvaRing; contraceptive pill; efficacy; tolerability