دورية أكاديمية
Efficacy and safety of the contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive in Chinese women: a 1-year randomised trial
| العنوان: | Efficacy and safety of the contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive in Chinese women: a 1-year randomised trial |
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| المؤلفون: | Fan, Guang Sheng, Ren, Mulan, Di, Wen, Su, Ping, Chang, Qin, Wu, Shuying, Qin, Yun, Korver, Tjeerd, Marintcheva-Petrova, Maya, Yacik, Carol, Sisk, Christine McCrary, Wang, Guoqin |
| المساهمون: | Fan, GS (reprint author), Beijing Union Med Coll Hosp, 1 Shuai Fu Yuan, Beijing, Peoples R China., Beijing Union Med Coll Hosp, 1 Shuai Fu Yuan, Beijing, Peoples R China., Southeast Univ, Zhongda Hosp, Nanjing, Jiangsu, Peoples R China., Shanghai Jiao Tong Univ, Sch Med, Ren Ji Hosp, Dept Obstet & Gynecol, Shanghai, Peoples R China., Huazhong Univ Sci & Technol, Family Planning Res Inst, Tongji Med Coll, Wuhan, Peoples R China., Third Mil Med Univ, Southwest Hosp, Obstet & Gynecol, Chongqing, Peoples R China., Peking Univ, Hosp 3, Beijing, Peoples R China., Merck & Co Inc, Kenilworth, NJ USA. |
| المصدر: | PubMed ; SCI |
| بيانات النشر: | EUROPEAN JOURNAL OF CONTRACEPTION AND REPRODUCTIVE HEALTH CARE |
| سنة النشر: | 2016 |
| المجموعة: | Peking University Institutional Repository (PKU IR) / 北京大学机构知识库 |
| مصطلحات موضوعية: | Compliance, contraceptive pill, efficacy, NuvaRing, tolerability, 30 MU-G, ETHINYL ESTRADIOL, CYCLE CONTROL, USER ACCEPTABILITY, ETONOGESTREL, DROSPIRENONE, MG |
| الوصف: | Objectives: The aim of the study was to assess the efficacy and tolerability of the monthly vaginal ring (NuvaRing; 15g ethinylestradiol [EE] and 120g etonogestrel per day) compared with a monophasic (21/7) combined oral contraceptive (COC) containing 30g EE and 3mg 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. ; Merck & Co., Inc., Kenilworth, NJ, USA ; SCI(E) ; PubMed ; ARTICLE ; fgsxiehe@163.com ; 4 ; 303-309 ; 21 |
| نوع الوثيقة: | journal/newspaper |
| اللغة: | English |
| تدمد: | 1362-5187 1473-0782 |
| العلاقة: | EUROPEAN JOURNAL OF CONTRACEPTION AND REPRODUCTIVE HEALTH CARE.2016,21(4),303-309.; 1430790; http://hdl.handle.net/20.500.11897/491686Test; WOS:000381361100007 |
| DOI: | 10.1080/13625187.2016.1186269 |
| الإتاحة: | https://doi.org/20.500.11897/491686Test https://doi.org/10.1080/13625187.2016.1186269Test https://hdl.handle.net/20.500.11897/491686Test |
| رقم الانضمام: | edsbas.7CEA1670 |
| قاعدة البيانات: | BASE |
| تدمد: | 13625187 14730782 |
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| DOI: | 10.1080/13625187.2016.1186269 |