The Effects of Contraceptive Pill and Hormonal Vaginal Ring on Hormonal, Inflammatory and Metabolic Parameters in Women of Reproductive Age With Polycystic Ovary Syndrome (PCOS).
试验速览
- 阶段
- 4 期
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in Matsuda index during the oral contraceptive pill (E-E-desogestrel)/vaginal ring (E-E -ethonogestrel)
研究概览
简要总结
The main aims of this study are:
- to investigate and compare the effects of long lasting use (59 weeks) of vaginal and oral contraceptives on androgen secretion, insulin and glucose metabolism, lipid profile, and serum levels of SHBG and hs-CRP in women with PCOS.
- to compare the metabolic effects of oral and vaginal combined contraceptives and to find out whether oral or transvaginal contraceptive can be recommended to a particular group of women, for example in women with increased metabolic risks.
- to clarify whether the unfavourable effects of combined contraceptives diminish with time (after use of one year).
详细描述
The study population consists of women of reproductive age with PCOS, no wish of pregnancy and no other contraindications to hormonal contraceptives.
The volunteer subjects will be recruited from hospital's patient files with PCOS (IC diagnosis E.28.2).
Methods Sample size Our previous study comparing the metabolic effects of the same preparations (Mercilon and Nuvaring) in young healthy women shown an significant decrease of 1.65 (SD 1.68)in the Matsuda index at 9 weeks of treatment with oral contraceptive pill. Power analysis indicated that 14 women would be needed in both groups to reveal a similar significant decrease in the serum level of Matsuda index. To allow for drop-outs (estimated to be as high as 20-30%), the planned sample size will be 21 in each group.
Medication Forty women will be randomised either to the pill (n=21) or ring (n=21) group. The OC or contraceptive ring will be used in nine weeks periods. Every period will be followed by a break of one week.
In the pill group the subjects start the pill during the first days of the follicular phase of the cycle after the baseline examinations and continue nonstop for nine weeks, i.e. until the third package has ran out. This is followed by one weeks' break. The ring is replaced every three weeks and the treatment is continued nine weeks after which one week break follows. In both groups the cycle will be repeated six times resulting in 59 weeks of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women aged between 18 to 40 years
- •diagnosed PCOS (Rotterdam criteria)
- •healthy, no medications
- •no use of hormonal contraceptives or wash-out period of at least two months
- •no contraindications to hormonal contraception
排除标准
- •regular smoking
- •excessive alcohol use
- •pregnancy or breastfeeding
- •oversensitivity to active ingredients
- •migraine with focal aura
- •severe or multiple risk factors to thrombosis
- •diagnosed or suspected cancer
- •diagnosed or suspected estrogen-dependent tumor
- •acute or chronic hepatocellular disease -related abnormal liver function
- •hepatic adenomas or carcinomas
- •undiagnosed abnormal vaginal bleeding
结局指标
主要结局
Change in Matsuda index during the oral contraceptive pill (E-E-desogestrel)/vaginal ring (E-E -ethonogestrel)
时间窗: Change from baseline in Matsuda index at 59 weeks of treament
Calculation of the Matsuda index according to the following equation: \[10000 / √((fasting glucose x fasting insulin)x (Gmeanogtt x Imeanogtt))\]
次要结局
- Change in high sensitive C-reactive protein (mg/l) during the oral contraceptive pill (E-E-desogestrel)/vaginal ring (E-E -ethonogestrel)(Change from baseline in serum CRP concentrations at 59 weeks of treament)
- Change in Free Androgen Index during the oral contraceptive pill (E-E-desogestrel)/vaginal ring (E-E -ethonogestrel)(Change from baseline in Free Androgen Index at 59 weeks of treament)