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CompletedNCT06530498Updated Apr 2, 2026

Diagnostics of Clinical Hyperandrogenism

An observational study in Anovulation and PCOS, sponsored by Jagiellonian University. Completed at 1 site in Poland. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by Jagiellonian University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,330
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.
02

Conditions studied

  • Anovulation
  • PCOS

Keywords

  • Hirsutism
  • Normogonadotropic Anovulation
  • PCOS
  • androgenetic alopecia
03

In context

Anovulation

75 studies on the registry are indexed under Anovulation; 7 are open to participants now.

This study's enrollment of 1,330 is above the median of 300 across 17 observational studies indexed under Anovulation.

Browse Anovulation studies →

Lead sponsor

Jagiellonian University is the lead sponsor of 161 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • virilizing tumors
  • congenital adrenal hyperplasia
  • ovarian hyperthecosis
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,330 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 · Diagnostic Test: Assessment of the severity of endogenetic alopecia using the visual Ludwig Scale

  • 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 · Diagnostic Test: Assessment of the severity of endogenetic alopecia using the visual Ludwig Scale

Interventions

  • Diagnostic testAssessment 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 testAssessment 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 6 months

  2. 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

    Time frame: up to 6 months

  3. 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

    Time frame: up to 6 months

  4. 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

    Time frame: up to 6 months

07

Study locations

1 site
  • Jagiellonian University Medical College
    Krakow, 31-501, Poland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06530498
Responsible party
Iwona Magdalena Gawron (MD, PhD, Jagiellonian University) — Principal investigator
First posted
Jul 31, 2024
Start date
Feb 29, 2024
Primary completion
Jun 30, 2025
Completion
Oct 30, 2025
Last update
Apr 2, 2026

Study contacts

Kazimierz Pityński, Prof.
study chair · Jagiellonian University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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