Diagnostics of Clinical Hyperandrogenism

NCT ID: NCT06530498

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-08
• Study Completion Date: 2025-12-31

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, 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.

Conditions

Anovulation; PCOS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

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

Intervention Type: 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

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

Intervention Type: 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)

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

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

Intervention Type: 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

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

Intervention Type: 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)

Interventions

Assessment 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

Intervention Type: DIAGNOSTIC_TEST

Assessment 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)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jagiellonian University

OTHER

Sponsor Role: lead

Responsible Party

Iwona Magdalena Gawron

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kazimierz Pityński, Prof., PhD, MD

Role: STUDY_CHAIR

Jagiellonian University

Locations

Jagiellonian University Medical College

Krakow, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Iwona Gawron, MD, PhD

Role: CONTACT

iwona.gawron@uj.edu.pl

+48 124248570

Robert Jach, Prof., PhD, MD

Role: CONTACT

jach@cm-uj.krakow.pl

+48 124248570

Facility Contacts

Iwona Gawron, PhD, MD

Role: primary

iwona.gawron@uj.edu.pl

+124248570

Other Identifiers

118.0043.1.24.2024

Identifier Type: -

Identifier Source: org_study_id