Early Phase 1 Ovarian Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Women aged 18 to 30 years who started their period at least 4 years ago and have been diagnosed with polycystic ovary syndrome (PCOS), shown by signs of excess male hormones (such as excess body hair and/or high testosterone levels) and irregular periods (fewer than 9 per year), with no other known cause for these symptoms — this is the PCOS group
• Women aged 18 to 30 years who started their period at least 4 years ago, have regular periods every 26 to 35 days, and show no signs of excess male hormones — this is the control (comparison) group
• People who are generally in good health, noting that being overweight, having obesity, having PCOS, or having well-managed underactive thyroid does not automatically rule someone out
• People who are able to understand the study and willing to give their formal agreement to take part
• People who are willing to reliably avoid pregnancy using non-hormonal methods throughout the study

Who may not be able to join:

• People who are unable or not in a position to give informed consent
• Males, as the study focuses on a condition specific to females
• People younger than 18 years old
• People older than 30 years old
• People whose obesity is caused by a specific hormonal disorder or genetic condition
• People who are currently pregnant or breastfeeding
• People whose excess male hormones or lack of ovulation appear to be caused by something other than PCOS or normal variation
• People showing signs of virilisation, which means rapid and significant development of male physical characteristics such as a deepening voice, rapid excess hair growth, or enlargement of the clitoris
• People with a total testosterone level above 150 ng/dl, which may suggest a hormone-producing tumour (confirm with trial site)
• People with certain hormone levels outside acceptable ranges, including specific elevations of a hormone called DHEA-S (confirm with trial site for exact thresholds)
• People with an early morning level of a hormone called 17-hydroxyprogesterone above 200 ng/dl, which may suggest a condition called congenital adrenal hyperplasia — repeat testing and additional assessments may apply (confirm with trial site)
• People with an abnormal thyroid stimulating hormone (TSH) level, although people with stable, well-treated underactive thyroid and normal TSH results are not automatically excluded
• People with elevated prolactin levels (a hormone made by the pituitary gland) — stricter limits apply to the control group, while mild elevations within 20% above the upper normal limit may be accepted in the PCOS group (confirm with trial site)
• People with signs or history suggesting Cushing's syndrome, adrenal insufficiency, or acromegaly (conditions involving hormone or growth abnormalities)
• People with signs or history suggesting very low reproductive hormone activity, including conditions such as functional hypothalamic amenorrhea, which may be linked to very restrictive eating, excessive exercise, or significant psychological stress
• People with persistently low red blood cell levels (haematocrit below 36% or haemoglobin below 12 g/dl)
• People with very low platelet counts (below 50,000 cells per microlitre) or very low white blood cell counts (below 4,000 cells per microlitre)
• People with a previous diagnosis of diabetes, a fasting blood sugar of 126 mg/dl or higher, or a HbA1c result of 6.5% or higher
• People with persistent abnormal liver test results, with limited exceptions for known Gilbert's syndrome or mild elevations seen in obesity or PCOS (confirm with trial site)
• People with a significant history of heart or lung problems, such as heart failure or asthma requiring regular steroid medication
• People with reduced kidney function, indicated by a filtration rate below 60 ml/min/1.73m²
• People with a personal history of breast, ovarian, or endometrial (uterine) cancer
• People with a history of any other cancer diagnosis or treatment (except certain skin cancers) unless they have been clinically free of disease for at least five years based on appropriate monitoring
• People with a known allergy to estradiol skin patches
• People with a BMI below 18 or above 40 kg/m²
• People whose menstrual cycles are consistently shorter than 26 days

Important: Always verify eligibility with the trial site directly before applying.