Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT05263557
Eligibility Criteria:
Inclusion Criteria:
* Women with a confirmed diagnosis polycystic ovary syndrome with androgen excess on clinical or biochemical grounds
* BMI 20.0-39.9kg/m2
* Age range 18-40 years
* Ability to provide informed consent
Exclusion Criteria:
* 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 3-months)
* Blood haemoglobin \<12.0g/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 or Treatment with anticoagulant agents
* 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.
* 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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT05263557
Study Brief:
Protocol Section:
NCT05263557