Early Phase 1 Ovarian Cancer Trial, Recruiting

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

Who might be able to join this trial:

• You are a girl who has gone through a mid-to-late stage of puberty (breast development at a certain level) and started your period no more than 2 years ago
• You have higher-than-normal levels of male hormones (such as testosterone) in your blood, or you have clearly visible excess body hair (hirsutism)
• You are in generally good health, apart from being overweight or obese, having high male hormone levels, or having a well-controlled thyroid condition
• You (and your parent or guardian, if you are under 16) are willing and able to give your agreement to take part in the study
• You are willing to avoid getting pregnant by using reliable non-hormonal birth control during the study

Who may not be able to join:

• You are unable or not allowed to give your agreement to take part
• You are male
• Your obesity is caused by a known hormonal disorder or genetic condition
• You are currently pregnant or breastfeeding
• Your high male hormone levels or irregular periods appear to be caused by something other than a natural hormonal imbalance or PCOS (a common hormonal condition)
• You show signs of strong male-like physical changes, such as rapidly increasing body hair, a deepening voice, or enlargement of certain body parts
• Your total testosterone level is above 150 ng/dl, which could suggest a hormone-producing tumour (confirm with trial site)
• A specific hormone called DHEA-S is more than 1.5 times the upper limit of the normal range (mild increases may still be accepted — confirm with trial site)
• A hormone called 17-hydroxyprogesterone, measured early in the morning at a certain point in your cycle, is above 200 ng/dl, which could suggest a particular adrenal gland condition (further testing may be needed — confirm with trial site)
• Your thyroid hormone level (TSH) is outside the normal range (note: a well-controlled thyroid condition with normal TSH is acceptable)
• Your prolactin hormone level is more than 20% above the upper limit of normal (small increases may still be accepted — confirm with trial site)
• You have signs or a history of certain hormonal conditions affecting the adrenal gland or pituitary gland, such as Cushing's syndrome, adrenal insufficiency, or acromegaly
• You have signs of a condition where the body does not produce enough sex hormones (including a condition caused by extreme stress, very restrictive eating, or excessive exercise)
• Your blood count (red blood cells) is persistently low, suggesting possible anaemia
• Your platelet count or white blood cell count is severely low
• You have been diagnosed with diabetes, or your fasting blood sugar or a related blood test result is above a certain level
• You have ongoing abnormal liver test results (small increases may be accepted in some cases — confirm with trial site)
• You have a significant history of heart or lung problems, such as heart failure or asthma that requires regular steroid treatment
• Your kidneys are not working well enough (below a certain filtering level)
• You have a personal history of breast, ovarian, or womb cancer
• You have a history of any other cancer (except certain common skin cancers) unless you have been free of the disease for at least 5 years
• You have had an allergic reaction to micronized progesterone or spironolactone (medications used in this study)
• Your weight is too low for your age and height (BMI below the 5th percentile for your age)
• You weigh less than 25 kg (about 55 lbs), due to the amount of blood needed for the study
• You have taken certain medications in the past 2–3 months that can affect hormones, blood sugar, cholesterol, or blood pressure — these include the contraceptive pill, some diabetes medications, steroids, certain antipsychotics, and some stimulant medications (such as those used for ADHD)

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