Diagnostics of Clinical Hyperandrogenism

NCT06530498 | Completed DMC

• 1 other identifier: 118.0043.1.24.2024
• Study Type: observational
• Target: 1,330
• Locations: 1 country
• Sites: 1

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.

Conditions

Anovulation; PCOS

Keywords

Hirsutism; Normogonadotropic Anovulation; PCOS; androgenetic alopecia

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Study Arms (2)

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

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)

Hypothalamic-pituitary-ovarian dysfunction (HPOD); Polycystic ovary syndrome (PCOS)

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

Hypothalamic-pituitary-ovarian dysfunction (HPOD); Polycystic ovary syndrome (PCOS)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• virilizing tumors
• congenital adrenal hyperplasia
• ovarian hyperthecosis

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University Medical College

Krakow, 31-501, Poland

Location

MeSH Terms

Conditions

Anovulation; Hirsutism; Alopecia

Condition Hierarchy (Ancestors)

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

Study Officials

• Kazimierz Pityński, Prof.

  Jagiellonian University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: July 31, 2024
• Study Start: February 29, 2024
• Primary Completion: June 30, 2025
• Study Completion: October 30, 2025
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

PL (1)