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Diagnostics of Clinical Hyperandrogenism

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06530498
Enrollment
1330
Registered
2024-07-31
Start date
2024-02-29
Completion date
2025-10-30
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anovulation, PCOS

Keywords

Hirsutism, Normogonadotropic Anovulation, PCOS, androgenetic alopecia

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 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.

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

Sponsors

Jagiellonian University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of the severity of hirsutism in the PCOS and HPOD groupsup to 6 monthsComparison 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 groupsup to 6 monthsComparison 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 populationup to 6 monthsThe 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 hyperandrogenismup to 6 monthsThe correlation of mFG and LS scale scores in the study population will be assessed using standard statistical methods

Countries

Poland

Contacts

STUDY_CHAIRKazimierz Pityński, Prof.

Jagiellonian University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026