Diagnostics of Clinical Hyperandrogenism Using the Modified Ferriman-Gallwey Scale and the Ludwig Scale in Women With Normogonadotropic Anovulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Comparison of the severity of hirsutism in the PCOS and HPOD groups
研究概览
简要总结
The optimal cut-off value for diagnosing hirsutism in the modified Ferriman-Gallwey (mFG) point scale in the Polish population is not known. The correlation of mFG with the severity of androgenetic alopecia in the Ludwig scale (LS) is not known.
The aim of the study is to determine the cut-off point for the diagnosis of hirsutism and to assess the correlation of the mFG scale score with the LS of androgenetic alopecia severity.
详细描述
The aim of the study is to:
- determine the cut-off point on the mFG scale, indicating hirsutism and to determine the correlation of the severity of androgenetic alopecia on the Ludwig scale with the mFG value in the population of women diagnosed and treated at the University Hospital in Krakow due to anovulation.
- to determine the severity of hirsutism and the severity of androgenetic alopecia in individual PCOS phenotypes.
Inclusion criteria are as follows: i) oligoovulation, i.e. menstrual cycles every <21 days or >35 days, ii) age 18-45 years, iii) diagnosis of PCOS.
Exclusion criteria: none.
To achieve the study objectives, the following will be performed:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •oligoovulation, i.e. menstrual cycles every <21 days or >35 days
- •age 18-45 years
- •diagnosis of PCOS.
排除标准
- 未提供
结局指标
主要结局
Comparison of the severity of hirsutism in the PCOS and HPOD groups
时间窗: up to 6 months
Comparison of the mFG score in the PCOS and HPOD groups; The modified Ferriman-Gallwey (mFG) scale assesses the severity of excessive hair growth on a scale of 0-4 points in 9 body regions (Upper lip, Chin, Chest, Upper back, Lower back, Upper abdomen, Lower abdomen, Upper arms, Thighs); the lowest possible score is 0 and the highest is 36; the higher the score, the greater the severity of excess hair
Comparison of the severity of endogenetic alopecia in the PCOS and HPOD groups
时间窗: up to 6 months
Comparison of the LS score in the PCOS and HPOD groups; The Ludwig Scale (LS) assesses the severity of androgenetic alopecia on a scale from I to III, with additional sub-points within some of the above grades, i.e. I-1, I-2, I-3, I-4, II-1, II-2, III, IV (frontal - advanced); the higher the grade, the greater the severity of alopecia
Calculation of cut-off point for diagnosing hirsutism in the study population
时间窗: up to 6 months
The cut-off point for diagnosing hirsutism will be calculated using the receiver operating characteristic curve
Assessment of diagnostic convergence of mFG and LS scales in diagnosing clinical hyperandrogenism
时间窗: up to 6 months
The correlation of mFG and LS scale scores in the study population will be assessed using standard statistical methods
次要结局
未报告次要终点
研究者
Iwona Magdalena Gawron
MD, PhD
Jagiellonian University