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NCT Number: NCT06820450

Pilot Study to Characterize the Endometriosis Steroidome and Its Link to Endocrine Disruptors and Vaginal Dysbiosis

Endometriosis is a systemic, steroid-dependent, inflammatory disease characterized by the growth of endometrial-like tissue outside the uterus, affecting approximately 10 % of women of childbearing age. The etiology and pathophysiology of endometriosis is not completely understood to support effective treatment and prevention strategies. Despite the steroid dependency, little is known concerning the underlying metabolism of estrogen and other tightly related steroids. Moreover, shortening the long diagnostic delays is a major priority in endometriosis research.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

The main aim of the study will be to develop a global steroidomics analytical strategy " fit-for-purpose" to improve the knowledge of endometriosis pathophysiology and boost the identification of diagnostic biomarkers.

Therefore, in a first step, a new analytical method will be developed adapting state-of-the-art liquid chromatography coupled to high resolution mass spectrometry (LC-HRMS) approaches for steroids and its metabolites towards endometriosis research. The investigators will ensure the characterization of established steroids and its metabolites known to be relevant to endometriosis, but also expand the panel with non-targeted methods to identify phase-1 and -2 metabolites potentially informing of novel steroidogenic pathways in serum and urine.

In a second phase, a case-control study will be conducted to apply the strategy in a sample of women with and without endometriosis. In a third step, the investigators will explore statistical differences in steroid profiles among endometriosis groups and evaluate the discriminative performance.

The proposed method has large applications in endometriosis research and large potential to provide novel clues about the still poorly understood steroid metabolism disruption undergoing in endometriosis. Ultimately, non-invasive biomarker discovery in urine could revolutionize endometriosis diagnosis and management, allowing for earlier detection and personalized treatment strategies, ultimately improving the lives of individuals affected by this often overlooked but debilitating condition.

In parallel, the role of dysbiosis of the vaginal microbiota on hormonal alterations linked to endometriosis will be studied.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 18 to 45
  • Free, informed and written consent from the patient to participate in the study
  • Good understanding of the French language
  • Patient affiliated to or benefiting from a social security or similar scheme

Specific inclusion criteria for each group:

Group 1. Controls.

  • Women with no laparoscopically confirmed signs suggestive of deep endometriosis.
  • No clinico-biological criteria in favour of a diagnosis of endometriotic disease, nor any radiological signs (ultrasound or MRI) suggestive of endometriosis.

Group 2. Cases of deep endometriosis.

  • Newly diagnosed women (less than 12 months).
  • Severe, deep endometriotic pathology with surgical indication (clinical examination, imaging tests, pre-operative findings).

Exclusion criteria

  • Intercurrent diagnosis of pregnancy.
  • Presence of other hormone-dependent pathologies (e.g. breast cancer, PCOS).
  • Acute infection.

Treatment and study plan

Blood Test

Other

A blood test (2 x 5 ml dry tubes) will be taken to analyze steroid profiles

Urine sample

Other

a 20 ml urine sample will be taken to analyze steroid profiles

vaginal sample

Other

to characterize the microbiota.

Primary outcomes

  1. Identify steroid profiles associated with endometriosis

    Time frame: Sampling at inclusion visit

    Statistical associations between steroids and the presence of endometriosis.

Secondary outcomes

  1. Identify biomarkers of environmental chemical exposure associated with endometriosis and steroid profiles.

    Time frame: Sampling at inclusion visit

    Statistical difference between environmental chemical and steroid exposure profiles between subgroups of the study populations.

  2. Identify the role of vaginal microbiota dysbiosis on hormonal alteration in endometriosis

    Time frame: Sampling at inclusion visit

    Presence of a specific bacterial community in the vaginal microbiota

Study contacts

Contact information is provided by the study sponsor or research team.

Stéphane PLOTEAU, PU-PH

CONTACT

Sté[email protected]

02.40.08.76.84 ext. +33

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

STERONLINE: Steroidome and Exposome of Endometriosis Single-center Case-control Study

Acronym: STERONLINE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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