Investigating the link between androgens and metabolic risk in women
Official title: FEmale Metabolic Risk and Androgens: an Irish Longitudinal (FEMAIL) Study
Run by Royal College of Surgeons, Ireland · NCT04912648 · Data updated 2026-11-12
This study is trying to see how hormone levels affect the risk of metabolic diseases in women with polycystic ovary syndrome (PCOS).
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 500 (estimated) |
| Sponsor | Royal College of Surgeons, Ireland Academic / other |
| Locations | 1 site (Dublin) |
| Status | Recruiting |
| Started | April 1, 2021 |
| Main results expected | September 1, 2025 |
| Study ends | August 31, 2031 |
| Registry record updated | May 2, 2024 |
| Trial ID | NCT04912648 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 18 years or older who can provide informed consent and have a diagnosis of PCOS or related metabolic conditions.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or have significant renal or hepatic impairments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the relationship between androgen levels and metabolic diseases, particularly focusing on polycystic ovary syndrome (PCOS) in women. Researchers will collect detailed medical histories, anthropometric measurements, and various biological samples, including blood, urine, and saliva, to analyze metabolic phenotypes and steroid profiles. The study employs advanced liquid chromatography-tandem mass spectrometry (LC-MS/MS) techniques to assess the impact of 11-oxygenated androgens on metabolism and glucose homeostasis. Participants will also complete quality of life questionnaires to provide additional context to their health status.
Why it matters
Potential benefit: If successful, this study could enhance understanding of metabolic risks associated with androgen excess, potentially leading to improved management strategies for women with PCOS.
How similar studies have gone: While the study explores novel aspects of androgen metabolism, previous studies have shown success in understanding the metabolic implications of androgens in women, indicating a promising area of research.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or above * Ability to provide informed consent Exclusion Criteria: * Pregnancy or breastfeeding at the time of planned recruitment * History of significant renal (eGFR\<30) or hepatic impairment (AST or ALT \>two-fold above ULN; pre-existing bilirubinaemia \>1.2 ULN) * The investigators will retain the right not to recruit potential participants with severe health disorders which may impact on their ability to participate in the study; these may include, but are not limited to, metastatic cancer, severe cardio-respiratory disease or other life-limiting health disorders * Participants who have participated in another research study involving an investigational medicinal product in the 12 weeks preceding the planned recruitment * Glucocorticoid use via any route within the last six months * Current intake of drugs known to impact upon steroid or metabolic function or intake of such drugs during the six months preceding the planned recruitment * Use of combined oral hormonal contraception in the three months preceding the planned recruitment
Where it's running
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Royal College of Surgeons in Ireland
Dublin, Ireland Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.