Clinical Efficacy and Metabolic Impact of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Normal-weight Women With Polycystic Ovary Syndrome: a Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women
研究概览
简要总结
The estrogenic component of estro-progestin (EP) is responsible for a negative impact on the metabolic and lipid assessment in women with polycystic ovary syndrome (PCOS).
The objective of this study is to compare the effects of a long term administration of two EP combinations, containing the same progestin (3 mg drospirenone) and a different dose of ethinyl-estradiol (EE) (20 vs 30 μg ) on the clinical and endocrine-metabolic parameters in normal weight PCOS women. The investigators enrolled 30 patients, randomly allocated to group A (20 µg EE - 3 mg DRSP) and 15 to group B (30 µg EE - 3 mg DRSP). Hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile were performed at baseline and after 6 and 12 months of therapy.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •normal weight women with Polycystic ovary syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003.
排除标准
- •pregnancy
- •past history of cardiovascular disease, diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 g oral glucose tolerance test), hypertension
- •significant liver or renal impairment
- •other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs)
- •neoplasms
- •unstable mental illness
研究组 & 干预措施
3 mg drospirenone and 20 µg ethinyl-estradiol
干预措施: 3 mg drospirenone and 20 µg ethinyl-estradiol (Drug)
3 mg drospirenone and 30 µg ethinyl-estradiol
干预措施: 3 mg drospirenone and 30 µg ethinyl-estradiol (Drug)
结局指标
主要结局
To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women
时间窗: twelve months
hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile
次要结局
未报告次要终点
研究者
Maurizio Guido
medical doctor
Catholic University of the Sacred Heart