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Not yet recruitingNCT07253454HYPERMETABOUpdated Dec 4, 2025

Combined Use of Machine Learning and Metabolomics to Improve the Diagnosis and Management of Hyperandrogenism

An observational study in Hyperandrogenism, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to female participants aged 16 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-12-04.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
800
Ages
16 Years to 45 Years
Sex
Female
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Study 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. 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

02

Conditions studied

  • Hyperandrogenism

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Keywords

  • fertility
03

In context

Hyperandrogenism

81 studies on the registry are indexed under Hyperandrogenism; 22 are open to participants now.

This study's planned enrollment of 800 is above the median of 135 across 26 observational studies indexed under Hyperandrogenism.

Browse Hyperandrogenism studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Patients under legal protection measures
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
800 participants (estimated)
Patient registry
No

Groups and cohorts

  • principal group

    Other: data collection

Interventions

  • Otherdata collection

    collection of data from medical records over a period of 5 years

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What researchers measure

Primary outcomes

  1. Use of machine learning models combined with metabolomics to distinguish between different causes of hyperandrogenism

    Time frame: 5 years

Secondary outcomes

  1. Use of metabolomics to improve the management of patients with hyperandrogenism

    Time frame: 5 years

  2. Use of metabolomics to predict CYP21A2 genotyping results

    Time frame: 5 years

  3. Study of the impact of anti-androgenic hormone therapy on the predictive capabilities of the model

    Time frame: 5 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Informed consent form

Time frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor

Access criteria: Researchers who provide a methodologically sound proposal.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2026; primary completion for Dec 2040, 179 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2025
First posted
Nov 28, 2025
StartEst.
Jan 2026
Primary completionEst.
Dec 2040
CompletionEst.
Dec 2040
Last update
Dec 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07253454
Responsible party
Sponsor
First posted
Nov 28, 2025
Start date
Jan 2026 (estimated)
Primary completion
Dec 2040 (estimated)
Completion
Dec 2040 (estimated)
Last update
Dec 4, 2025

Study contacts

Anne Pr BACHELOT
Contact
anne.bachelot@aphp.fr
0033 01 42 16 02 46

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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