Diagnostics of Clinical Hyperandrogenism

Diagnostics of Clinical Hyperandrogenism Using the Modified Ferriman-Gallwey Scale and the Ludwig Scale in Women With Normogonadotropic Anovulation

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.

Study Overview

• Status: Completed
• Conditions: PCOS; Anovulation
• Intervention / Treatment: 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

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 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 Type: Observational
• Enrollment (Actual): 1330

Contacts and Locations

Study Locations

• Poland
  • Krakow, Poland, 31-501
    • Jagiellonian University Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Women diagnosed and treated at the University Hospital in Krakow due to normogonadotropic anovulation

Description

Inclusion Criteria:

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

Exclusion Criteria:

• virilizing tumors
• congenital adrenal hyperplasia
• ovarian hyperthecosis

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Polycystic ovary syndrome (PCOS); Women diagnosed with polycystic ovary syndrome based on International Evidence-based Guideline for the assessment and management of polycystic ovary syndrome (2023)	Diagnostic test: Assessment of the severity of hirsutism using the visual modified Ferriman-Gallwey scale; Assessment of the severity of hirsutism using the visual modified Ferriman-Gallwey scale in 9 body regions rated from 0 (no growth of terminal hair) to 4 (extensive hair growth), thus with a score ranging from 0 (the lowest score - no hirsutism) to 36 points (the highest score - the greatest severity of hirsutism); Diagnostic test: Assessment of the severity of endogenetic alopecia using the visual Ludwig Scale; Visual assessment of baldness on the Ludwig scale from I (least severe baldness) to III (most severe baldness): Type I - minimal thinning of the mid-line parting in the hair; Type II - gradual thinning and noticeable widening of the mid-line parting in the hair; Type III - Heavy to total thinning of the mid-line
Hypothalamic-pituitary-ovarian dysfunction (HPOD); Women diagnosed with hypothalamic-pituitary-ovarian dysfunction based on The FIGO ovulatory disorders classification system (2022)	Diagnostic test: Assessment of the severity of hirsutism using the visual modified Ferriman-Gallwey scale; Assessment of the severity of hirsutism using the visual modified Ferriman-Gallwey scale in 9 body regions rated from 0 (no growth of terminal hair) to 4 (extensive hair growth), thus with a score ranging from 0 (the lowest score - no hirsutism) to 36 points (the highest score - the greatest severity of hirsutism); Diagnostic test: Assessment of the severity of endogenetic alopecia using the visual Ludwig Scale; Visual assessment of baldness on the Ludwig scale from I (least severe baldness) to III (most severe baldness): Type I - minimal thinning of the mid-line parting in the hair; Type II - gradual thinning and noticeable widening of the mid-line parting in the hair; Type III - Heavy to total thinning of the mid-line

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculation of cut-off point for diagnosing hirsutism in the study population	The cut-off point for diagnosing hirsutism will be calculated using the receiver operating characteristic curve	up to 6 months
Assessment of diagnostic convergence of mFG and LS scales in diagnosing clinical hyperandrogenism	The correlation of mFG and LS scale scores in the study population will be assessed using standard statistical methods	up to 6 months
Comparison of the severity of hirsutism in the PCOS and HPOD groups	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	up to 6 months
Comparison of the severity of endogenetic alopecia in the PCOS and HPOD groups	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	up to 6 months

Collaborators and Investigators

• Sponsor: Jagiellonian University
• Investigators: Study Chair: Kazimierz Pityński, Prof., Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: July 28, 2024
• First Submitted That Met QC Criteria: July 28, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 28, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: PCOS; androgenetic alopecia; Hirsutism; Normogonadotropic Anovulation
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Skin Diseases; Hypotrichosis; Hair Diseases; Virilism; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Alopecia; Hirsutism; Anovulation
• Other Study ID Numbers: 118.0043.1.24.2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No