Early Phase 1 Sleep Disorders 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:

• Girls aged 10 to 17 years who are in the middle or later stages of puberty, based on breast development stage and/or whether their periods have started.
• Girls who have higher-than-normal levels of male hormones (such as testosterone) for their stage of puberty, or who have noticeable excess body hair.
• Girls who are generally in good health, noting that obesity, higher-than-normal male hormone levels, polycystic ovary syndrome (PCOS), and well-managed underactive thyroid do not automatically prevent participation.
• Girls who are willing to consistently use reliable non-hormonal methods to avoid becoming pregnant throughout the study.

Who may not be able to join:

• Anyone who is unable or not in a position to give informed consent to participate.
• Anyone who is male, as the trial specifically studies a condition that occurs in females.
• Girls younger than 10 or older than 17 years of age.
• Girls whose periods started more than 4 years ago.
• Girls whose obesity is caused by a clearly identified hormonal disorder or a known genetic condition.
• Girls weighing less than 21.5 kg (approximately 47 pounds), to ensure blood draws remain within safe limits.
• Girls whose weight-for-age places them below the 5th percentile on a BMI growth chart, as being underweight can affect the hormone patterns being studied.
• Girls who test positive for pregnancy, or who are currently breastfeeding.
• Girls whose high male hormone levels or lack of ovulation appear to be caused by something other than PCOS or normal hormonal variation.
• Girls showing signs of significant masculinisation, such as rapidly increasing body hair, a deepening voice, or changes to genital anatomy.
• Girls with a total testosterone level above 150 ng/dL, which may suggest the presence of a hormone-producing tumour.
• Girls with a particular hormone called DHEA-S at a level more than 1.5 times the upper limit of the normal range (mild elevations may be accepted — confirm with trial site).
• Girls with a specific hormone level (17-hydroxyprogesterone, measured in the morning during a particular phase of the menstrual cycle) above 300 ng/dL, which may suggest a condition called congenital adrenal hyperplasia — though repeat or additional testing may allow continued participation in some cases (confirm with trial site).
• Girls with a thyroid-stimulating hormone (TSH) level outside the range of 0.3 to 7 on repeat testing, unless the level has been stable for at least 6 months or the girl is on a stable thyroid medication dose — girls with adequately managed underactive thyroid may still be eligible (confirm with trial site).
• Girls with a prolactin hormone level above 30 ng/mL, confirmed on a repeat test.
• Girls with signs or history suggesting certain hormonal conditions, including Cushing's syndrome, adrenal insufficiency, or acromegaly.
• Girls with signs or history suggesting a condition where the brain is not sending proper signals for puberty or menstruation, including patterns linked to very restrictive eating, excessive exercise, or significant psychological stress.
• Girls with low haemoglobin (a measure of red blood cells) — the specific threshold differs slightly depending on whether the girl is African American or not (confirm with trial site for exact values).
• Girls with very low platelet counts or very low white blood cell counts, which relate to blood clotting and immune function.
• Girls with a previous diagnosis of diabetes, a fasting blood sugar level of 126 mg/dL or higher, or a certain long-term blood sugar measure (HbA1c) of 6.5% or higher.
• Girls with persistently abnormal sodium, potassium, or bicarbonate levels in their blood.
• Girls with significantly abnormal liver test results, though certain mild abnormalities may be accepted in specific circumstances (confirm with trial site).
• Girls with a known allergy to the study medication spironolactone, or with certain kidney, adrenal, or potassium-related conditions that make spironolactone unsafe to use, or who are currently taking a medication called eplerenone.
• Girls with significant heart or lung problems, such as heart failure or asthma requiring regular steroid medication.
• Girls with reduced kidney function below a certain threshold.
• Girls with a history of cancer diagnosis or treatment within the past five years (some types of skin cancer may be exceptions — confirm with trial site).

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