Investigating the link between androgens and metabolic risk in women
FEmale Metabolic Risk and Androgens: an Irish Longitudinal (FEMAIL) Study
Royal College of Surgeons, Ireland · NCT04912648
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Royal College of Surgeons, Ireland (other) |
| Locations | 1 site (Dublin) |
| Trial ID | NCT04912648 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are pregnant, breastfeeding, or have significant renal or hepatic impairments may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Dublin
- Royal College of Surgeons in Ireland — Dublin, Ireland (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hyperandrogenism, Metabolic Disease, Sex Hormones Adverse Reaction