AnovulationNCT06530498
Diagnostics of Clinical Hyperandrogenism
An observational study of Anovulation and PCOS, run by Jagiellonian University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anovulation, PCOS
- What is being tested?
- Assessment of the severity of hirsutism using the visual modified Ferriman-Gallwey scale and Assessment of the severity of endogenetic alopecia using the visual Ludwig Scale
- How many people
- 1,330 participants
- Where
- 1 sitePoland
- Study dates
- 29 Feb 2024to 30 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
Study population: Women diagnosed and treated at the University Hospital in Krakow due to normogonadotropic anovulation
Who may be able to join
- oligoovulation, i.e. menstrual cycles every <21 days or >35 days
- age 18-45 years
Who cannot join
- virilizing tumors
- congenital adrenal hyperplasia
- ovarian hyperthecosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostics of Clinical Hyperandrogenism Using the Modified Ferriman-Gallwey Scale and the Ludwig Scale in Women With Normogonadotropic Anovulation
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.
Read the 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.
- Conditions
- Anovulation, PCOS
- Being tested
- Assessment of the severity of hirsutism using the visual modified Ferriman-Gallwey scale, Assessment of the severity of endogenetic alopecia using the visual Ludwig Scale
- Keywords
- Hirsutism, Normogonadotropic Anovulation, PCOS, androgenetic alopecia
- Medical subject headings
- Anovulation, Hirsutism, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of the severity of hirsutism using the visual modified Ferriman-Gallwey scaleDiagnostic 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)
Assessment of the severity of endogenetic alopecia using the visual Ludwig ScaleDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start29 Feb 2024
- Primary completion30 Jun 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnovulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Magdalena Gawron, Jagiellonian University
- Investigators
- Kazimierz Pityński, Prof., Study chair, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530498
- Sponsor's protocol ID
- 118.0043.1.24.2024
- Status last verified
- Mar 2026
- First submitted
- 28 Jul 2024
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostics of Clinical Hyperandrogenism Using the Modified Ferriman-Gallwey Scale and the Ludwig Scale in Women With Normogonadotropic Anovulation
- ClinicalTrials.gov ID
- NCT06530498
- Acronym / sponsor ID
- 118.0043.1.24.2024
- Conditions
- Anovulation, PCOS
- Keywords
- Hirsutism, Normogonadotropic Anovulation, PCOS, androgenetic alopecia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,330 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polycystic ovary syndrome (PCOS) | – | 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 ScaleWomen diagnosed with polycystic ovary syndrome based on International Evidence-based Guideline for the assessment and management of polycystic ovary syndrome (2023) |
| Hypothalamic-pituitary-ovarian dysfunction (HPOD) | – | 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 ScaleWomen diagnosed with hypothalamic-pituitary-ovarian dysfunction based on The FIGO ovulatory disorders classification system (2022) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women diagnosed and treated at the University Hospital in Krakow due to normogonadotropic anovulation
Key inclusion criteria (2 listed)
- oligoovulation, i.e. menstrual cycles every <21 days or >35 days
- age 18-45 years
Key exclusion criteria (3 listed)
- virilizing tumors
- congenital adrenal hyperplasia
- ovarian hyperthecosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of the severity of hirsutism using the visual modified Ferriman-Gallwey scaleAssessment 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 test | Hypothalamic-pituitary-ovarian dysfunction (HPOD), Polycystic ovary syndrome (PCOS) |
| Assessment of the severity of endogenetic alopecia using the visual Ludwig ScaleVisual 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 | Diagnostic test | Hypothalamic-pituitary-ovarian dysfunction (HPOD), Polycystic ovary syndrome (PCOS) |
Primary outcome
Comparison of the severity of hirsutism in the PCOS and HPOD groups
Time frame: up to 6 months
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
Comparison of the severity of endogenetic alopecia in the PCOS and HPOD groups
Time frame: up to 6 months
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
Calculation of cut-off point for diagnosing hirsutism in the study population
Time frame: up to 6 months
The 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 hyperandrogenism
Time frame: up to 6 months
The correlation of mFG and LS scale scores in the study population will be assessed using standard statistical methods
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazimierz Pityński, Prof. study chair
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anovulation and PCOS, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the severity of hirsutism in the PCOS and HPOD groups (time frame: up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.