Status:
RECRUITING
FEmale Metabolic Risk and Androgens: an Irish Longitudinal (FEMAIL) Study
Lead Sponsor:
Royal College of Surgeons, Ireland
Conditions:
Hyperandrogenism
Metabolic Disease
Eligibility:
FEMALE
18+ years
Brief Summary
Androgen excess is the cardinal biochemical feature of polycystic ovary syndrome (PCOS), a lifelong metabolic disorder affecting 10% of women. Serum testosterone correlates with insulin resistance in ...
Detailed Description
Clinical questionnaire and baseline anthropometry: Study investigators will complete a standardised case record form, with information obtained on relevant medical history, medications and anthropome...
Eligibility Criteria
Inclusion
- Age 18 years or above
- Ability to provide informed consent
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2031
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04912648
Start Date
April 1 2021
End Date
August 31 2031
Last Update
May 2 2024
Active Locations (1)
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1
Royal College of Surgeons in Ireland
Dublin, Ireland, D9