Diagnostics of Clinical Hyperandrogenism

Recruiting

• Conditions: Anovulation; PCOS
• Interventions: Diagnostic Test: Assessment of the severity of hirsutism using the visual modified Ferriman-Gallwey scale; Diagnostic Test: Assessment of the severity of endogenetic alopecia using the visual Ludwig Scale

• Registration Number: NCT06530498
• Lead Sponsor: Jagiellonian University

Brief Summary

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.

Detailed Description

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:

* Visual assessment of the severity of hirsutism on the modified Ferriman-Gallwey scale

* Visual assessment of the severity of androgenetic alopecia on the Ludwig scale.

Study Timeline

• Study Start: 2024-02-08
• Study First Submitted: 2024-07-28
• Study First Submitted QC: 2024-07-28
• Study First Posted: 2024-07-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• oligoovulation, i.e. menstrual cycles every <21 days or >35 days
• age 18-45 years
• diagnosis of PCOS.

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Polycystic ovary syndrome (PCOS)	Assessment of the severity of endogenetic alopecia using the visual Ludwig Scale	Women diagnosed with polycystic ovary syndrome based on International Evidence-based Guideline for the assessment and management of polycystic ovary syndrome (2023)
Polycystic ovary syndrome (PCOS)	Assessment of the severity of hirsutism using the visual modified Ferriman-Gallwey scale	Women diagnosed with polycystic ovary syndrome based on International Evidence-based Guideline for the assessment and management of polycystic ovary syndrome (2023)
Hypothalamic-pituitary-ovarian dysfunction (HPOD)	Assessment of the severity of endogenetic alopecia using the visual Ludwig Scale	Women diagnosed with hypothalamic-pituitary-ovarian dysfunction based on The FIGO ovulatory disorders classification system (2022)
Hypothalamic-pituitary-ovarian dysfunction (HPOD)	Assessment of the severity of hirsutism using the visual modified Ferriman-Gallwey scale	Women diagnosed with hypothalamic-pituitary-ovarian dysfunction based on The FIGO ovulatory disorders classification system (2022)

Primary Outcome Measures

Name	Time	Method
Comparison of the severity of hirsutism in the PCOS and HPOD groups	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	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	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	up to 6 months	The correlation of mFG and LS scale scores in the study population will be assessed using standard statistical methods

Trial Locations

Locations (1)

Jagiellonian University Medical College; 🇵🇱 Krakow, Poland