NCT01372293已完成不适用
17-hydroxysteroid Dehydrogenase Type 5 Gene Polymorphism (71A/G HSD17B5 SNP) and Effects of Oral Contraceptive Pill on Hirsutism, Androgens and Metabolic Profile in Non-obese PCOS Women: a Pilot Study
Federal University of Rio Grande do Sul0 个研究点目标入组 49 人开始时间: 2005年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 主要终点
- Changes at Ferriman- Gallwey score
研究概览
简要总结
An association of the single nucleotide polymorphism (SNP) in the promoter gene that codify for 17b-HSD5 enzyme (71A>G) with polycystic ovary syndrome (PCOS) and hyperandrogenemia has been suggested in previous studies.
Given the role of 17b-HSD5 in androgenic metabolism producing testosterone from precursors, the investigators hypothesis is that women with PCOS and with the variant allele G have a poor response on hirsutism and on hormonal and metabolic variables after oral contraceptive pill (OCP) treatment for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •hirsute women with polycystic ovary syndrome
排除标准
- •Use of any drugs known to interfere with hormone levels for at least 3 months before the study
- •Women with type 2 diabetes, homa index > 3.8, liver or renal disease or thyroid dysfunction
- •Other hyperandrogenic disorders than PCOS
结局指标
主要结局
Changes at Ferriman- Gallwey score
时间窗: 6 months
次要结局
- Changes at testosterone levels(6 months)
- Changes in lipid profile(6 months)
研究者
Denusa Wiltgen
MD,PhD
Federal University of Rio Grande do Sul
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