HyperandrogenismHYPERMETABONCT07253454
Combined Use of Machine Learning and Metabolomics to Improve the Diagnosis and Management of Hyperandrogenism
An observational study of Hyperandrogenism, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Hyperandrogenism is a common reason for consultation, the causes of which can range from common conditions (PCOS) to rarer conditions with major genetic implications (NC21OHD). It is characterized by elevated levels of circulating androgens, mainly testosterone. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Hyperandrogenism
- What is being tested?
- data collection
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Dec 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The first stage of the study will involve participating centers selecting patients' medical records after verifying their eligibility. It should be noted that the control group will consist of a population for whom tests were carried out for symptoms that were ultimately ruled out with normal results.
Who may be able to join
- Patients of childbearing age (16 to 45 years old)
- Suffering from hyperandrogenism
- Established etiological diagnosis with elimination of differential diagnoses
- Informed and not opposed to the collection of their data for the purposes of the study
Who cannot join
- Pregnancy
- Patients under legal protection measures
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Hyperandrogenism is a common reason for consultation, the causes of which can range from common conditions (PCOS) to rarer conditions with major genetic implications (NC21OHD). It is characterized by elevated levels of circulating androgens, mainly testosterone. This excess of androgens usually manifests clinically as increased male-pattern hair growth and, less specifically, acne and alopecia. Its prevalence is estimated at between 6 and 12% in women of reproductive age, and its incidence is increasing.
It is also responsible for infertility. As a reminder, infertility is a major public health issue and affects more and more couples around the world.
The investigators therefore wish to develop innovative tools to improve the diagnosis and management of hyperandrogenism
Read the detailed description
Hyperandrogenism is a common reason for consultation, the causes of which can range from common conditions (PCOS) to rarer conditions with major genetic implications (NC21OHD). It is characterized by elevated levels of circulating androgens, mainly testosterone. This excess of androgens usually manifests clinically as increased male-pattern hair growth and, less specifically, acne and alopecia. Its prevalence is estimated at between 6 and 12% in women of reproductive age, and its incidence is increasing.
It is also responsible for infertility. As a reminder, infertility is a major public health issue and affects more and more couples around the world.
The investigators therefore wish to develop innovative tools to improve the diagnosis and management of hyperandrogenism
- Conditions
- Hyperandrogenism
- Being tested
- data collection
- Keywords
- fertility
- Medical subject headings
- Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
collection of data from medical records over a period of 5 years
| Study group | Role | What they receive |
|---|---|---|
| principal group | Not described Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of machine learning models combined with metabolomics to distinguish between different causes of hyperandrogenism
Measured: 5 years
Secondary outcomes (3)
Use of metabolomics to improve the management of patients with hyperandrogenism
Measured: 5 years
Use of metabolomics to predict CYP21A2 genotyping results
Measured: 5 years
Study of the impact of anti-androgenic hormone therapy on the predictive capabilities of the model
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study startJan 2026 (estimated)
- Primary completionDec 2040 (estimated)
- Study completionDec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperandrogenismStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253454
- Sponsor's protocol ID
- APHP251139
- Acronym
- HYPERMETABO
- Status last verified
- Oct 2025
- First submitted
- 19 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Use of Machine Learning and Metabolomics to Improve the Diagnosis and Management of Hyperandrogenism
- ClinicalTrials.gov ID
- NCT07253454
- Acronym / sponsor ID
- HYPERMETABO / APHP251139
- Conditions
- Hyperandrogenism
- Keywords
- fertility
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2040 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 28 Nov 2025 (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.
Hyperandrogenism is a common reason for consultation, the causes of which can range from common conditions (PCOS) to rarer conditions with major genetic implications (NC21OHD). It is characterized by elevated levels of circulating androgens, mainly testosterone. This excess of androgens usually manifests clinically as increased male-pattern hair growth and, less specifically, acne and alopecia. Its prevalence is estimated at between 6 and 12% in women of reproductive age, and its incidence is increasing.
It is also responsible for infertility. As a reminder, infertility is a major public health issue and affects more and more couples around the world.
The investigators therefore wish to develop innovative tools to improve the diagnosis and management of hyperandrogenism
Detailed description
Hyperandrogenism is a common reason for consultation, the causes of which can range from common conditions (PCOS) to rarer conditions with major genetic implications (NC21OHD). It is characterized by elevated levels of circulating androgens, mainly testosterone. This excess of androgens usually manifests clinically as increased male-pattern hair growth and, less specifically, acne and alopecia. Its prevalence is estimated at between 6 and 12% in women of reproductive age, and its incidence is increasing.
It is also responsible for infertility. As a reminder, infertility is a major public health issue and affects more and more couples around the world.
The investigators therefore wish to develop innovative tools to improve the diagnosis and management of hyperandrogenism
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| principal group | – | Other: data collection |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The first stage of the study will involve participating centers selecting patients' medical records after verifying their eligibility. It should be noted that the control group will consist of a population for whom tests were carried out for symptoms that were ultimately ruled out with normal results.
Key inclusion criteria (4 listed)
- Patients of childbearing age (16 to 45 years old)
- Suffering from hyperandrogenism
- Established etiological diagnosis with elimination of differential diagnoses
- Informed and not opposed to the collection of their data for the purposes of the study
Key exclusion criteria (2 listed)
- Pregnancy
- Patients under legal protection measures
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 |
|---|---|---|
| data collectioncollection of data from medical records over a period of 5 years | Other | principal group |
Primary outcome
Use of machine learning models combined with metabolomics to distinguish between different causes of hyperandrogenism
Time frame: 5 years
3 secondary outcomes
Use of metabolomics to improve the management of patients with hyperandrogenism
Time frame: 5 years
Use of metabolomics to predict CYP21A2 genotyping results
Time frame: 5 years
Study of the impact of anti-androgenic hormone therapy on the predictive capabilities of the model
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperandrogenism, run by Assistance Publique - Hôpitaux de Paris.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Pr BACHELOT (0033 01 42 16 02 46, anne.bachelot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of machine learning models combined with metabolomics to distinguish between different causes of hyperandrogenism (time frame: 5 years). 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 4 Dec 2025.