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NCT Number: NCT06530498

Diagnostics of Clinical Hyperandrogenism

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.

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Key information

Conditions

Anovulation Adnexal Diseases Alopecia Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Hair Diseases Hirsutism Hypotrichosis Ovarian Diseases PCOS Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Virilism

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Jagiellonian University Medical College

Krakow, 31-501, Poland

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment of the severity of hirsutism using the visual modified Ferriman-Gallwey scale

Diagnostic Test

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)

Assessment of the severity of endogenetic alopecia using the visual Ludwig Scale

Diagnostic Test

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

Primary outcomes

  1. Comparison of the severity of hirsutism in the PCOS and HPOD groups

    Time frame: 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

  2. Comparison of the severity of endogenetic alopecia in the PCOS and HPOD groups

    Time frame: 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

  3. Calculation of cut-off point for diagnosing hirsutism in the study population

    Time frame: up to 6 months

    The cut-off point for diagnosing hirsutism will be calculated using the receiver operating characteristic curve

  4. Assessment of diagnostic convergence of mFG and LS scales in diagnosing clinical hyperandrogenism

    Time frame: up to 6 months

    The correlation of mFG and LS scale scores in the study population will be assessed using standard statistical methods

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2024
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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