Status:
RECRUITING
REFUEL PCOS Study 1
Lead Sponsor:
Royal College of Surgeons, Ireland
Collaborating Sponsors:
University of Birmingham
University of Liverpool
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-50 years
Brief Summary
Polycystic Ovary Syndrome (PCOS) affects 10% of all women, and it usually co-exists with high levels of male pattern hormones (also termed androgens). Women with PCOS are at increased risk of metaboli...
Detailed Description
Polycystic ovary syndrome (PCOS) is a lifelong metabolic disorder, affecting 10-13% of all women, and is associated with a major healthcare and economic burden, estimated at $8 billion annually the US...
Eligibility Criteria
Inclusion
- \-
- The following inclusion criteria need to be met for the PCOS Study participants:
- Women with a confirmed diagnosis polycystic ovary syndrome with androgen excess on clinical or biochemical grounds
- BMI 20-40kg/m2
- Age range 18-50 years
- Ability to provide informed consent
- The following inclusion criteria need to be met for the control Study participants:
- No clinical features of possible polycystic ovary syndrome (absence of clinical features of androgen excess and ovulatory dysfunction).
- BMI 20.0-40kg/m2
- Age range 18-50 years
- Ability to provide informed consent
- For participants with PCOS, a diagnosis of PCOS should be established on the basis of the Androgen Excess and PCOS (AE-PCOS) Society guidelines:
- Androgen excess (clinical and/or biochemical evidence)
- Chronic oligo-/anovulation (clinical and/or biochemical evidence)
- Clinical and/or biochemical exclusion of other conditions that could explain the above manifestation (e.g. congenital adrenal hyperplasia, Cushing's syndrome, Prolactinoma, adrenal and gonadal tumours)
Exclusion
- The participant may not enter the study if ANY of the following apply:
- A confirmed diagnosis of diabetes
- Current or recent (\<3-months) use of weight loss medications
- Current or recent use of oral contraceptive pill or hormone replacement therapy (within last 3-months)
- Blood haemoglobin \<11.0g/dL
- History of alcoholism or a greater than recommended alcohol intake (recommendations \> 21 units on average per week for men and \> 14 units on average per week for women)
- Haemorrhagic disorders
- Treatment with anticoagulant agents
- Other co-morbidities that in the view of the investigators may affect data collection
- Any medical condition in the opinion of the investigator that might impact upon safety or validity of the results
- Pregnancy or breastfeeding at the time of planned recruitment
- A diagnosis of PCOS according to Rotterdam criteria where the patient does not have clinical or biochemical evidence of androgen excess
- History of significant renal (eGFR\<30) or hepatic impairment (AST or ALT \>two-fold above ULN; pre-existing bilirubinaemia \>1.2 ULN)
- Any other significant disease or disorder that, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- 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 oral or transdermal hormonal contraception in the three months preceding the planned recruitment
- Use of contraceptive implants in the twelve months preceding the planned recruitment
Key Trial Info
Start Date :
August 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05973175
Start Date
August 1 2023
End Date
October 1 2025
Last Update
April 17 2024
Active Locations (1)
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1
Royal Collage Of Surgeons
Dublin, Ireland