Efficacy and safety of the combined oral contraceptive ethinylestradiol/drospirenone (Yasmin) in healthy Chinese women: a randomized, open-label, controlled, multicentre trial
| Autor: | Huang Zirong, Han Zi-Yan, Xiong Zheng-ai, Fan Guang-Sheng, Cao Xiao-Ming, Yue Tianfu, Li Jian, Wu Shu-Ying, Cheng Li-Nan, Bian Mei-lu, Jing Xiao-Ping, Xiong Chengliang |
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| Rok vydání: | 2010 |
| Předmět: |
Adult
medicine.medical_specialty China Population Breast pain Ethinyl Estradiol law.invention Menstrual period Randomized controlled trial Body Water law Desogestrel Ethinylestradiol medicine Humans Pharmacology (medical) education Menstrual Cycle Gynecology education.field_of_study business.industry Body Weight Drospirenone General Medicine Contraceptives Oral Combined Contraception Baseline characteristics Androstenes Female medicine.symptom business Pearl Index Body mass index medicine.drug Follow-Up Studies |
| Zdroj: | Clinical drug investigation. 30(6) |
| ISSN: | 1173-2563 |
| Popis: | Objective: To evaluate and compare the contraceptive efficacy, bleeding pattern, side effects and other positive effects of a combined oral contraceptive (COC) containing drospirenone (DRSP) [Yasmin®] with those of a COC containing desogestrel (DSG) in healthy Chinese women. Methods: This was a randomized, open-label, controlled, multicentre study of 768 healthy Chinese women requiring contraception. The subjects were randomized to ethinylestradiol (EE) 30μg/DRSP 3mg (n = 573) or EE 30 μg/ DSG 150 μg (n= 195), at a ratio of 3:1. Each individual was treated for 13 cycles. Further visits were required at cycle 4, cycle 7, cycle 10 and cycle 13 of treatment. Weight, height and body mass index were evaluated at each visit. The Menstrual Distress Questionnaire (MDQ) was administered at baseline, visit 3 (cycle 7) and visit 5 (after cycle 13). Results: Baseline characteristics were similar between the two groups (p>0.05). The Pearl Index (method failure) for EE/DRSP was 0.208 per 100 women-years, which was lower than that for EE/DSG (0.601 per 100 women-years). There were no significant differences between the treatment groups with regard to bleeding patterns. According to the MDQ subscale, improvements in water retention and increases in appetite during the intermenstrual period and in water retention and general well-being during the menstrual period in the EE/DRSP group (−0.297, −0.057, 0.033 and 0.150, respectively) were significantly improved compared with the EE/DSG group (−0.108, 0.023, 0.231 and −0.023, respectively) [all p |
| Databáze: | OpenAIRE |
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