Diagnostics of Clinical Hyperandrogenism

Last updated: October 14, 2024
Sponsor: Jagiellonian University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Female Hormonal Deficiencies/abnormalities

Testotoxicosis

Treatment

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

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

Clinical Study ID

NCT06530498
118.0043.1.24.2024
  • Ages 18-45
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • oligoovulation, i.e. menstrual cycles every <21 days or >35 days

  • age 18-45 years

  • diagnosis of PCOS.

Exclusion

Exclusion Criteria:

  • none

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Assessment of the severity of endogenetic alopecia using the visual Ludwig Scale
Phase:
Study Start date:
February 08, 2024
Estimated Completion Date:
December 31, 2025

Study 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, iii) diagnosis of PCOS.

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.

Connect with a study center

  • Jagiellonian University Medical College

    Krakow, 31-501
    Poland

    Active - Recruiting

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