Diagnostics of Clinical Hyperandrogenism

Jagiellonian University

Status: Enrolling

Conditions: PCOS; Anovulation

Treatments: 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

Study type: Observational

Funder types: Other

Identifiers

NCT06530498

118.0043.1.24.2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• none

Trial design

300 participants in 2 patient groups

Polycystic ovary syndrome (PCOS)

Description:

Women diagnosed with polycystic ovary syndrome based on International Evidence-based Guideline for the assessment and management of polycystic ovary syndrome (2023)

Treatment:

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

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

Hypothalamic-pituitary-ovarian dysfunction (HPOD)

Description:

Women diagnosed with hypothalamic-pituitary-ovarian dysfunction based on The FIGO ovulatory disorders classification system (2022)

Treatment:

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

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