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 who are in the middle to later stages of puberty (at least Tanner breast stage 3) and are no more than 2 years past their first period
• Girls without signs of excess male hormones: those whose free testosterone level falls within the normal range for their stage of puberty and who do not have unusual body or facial hair growth
• Girls with signs of excess male hormones: those whose free testosterone level is higher than the normal range for their stage of puberty, and/or who have clear evidence of unusual body or facial hair growth
• Girls who are generally in good health (aside from being overweight or obese, having excess male hormones, or having an underactive thyroid that is being properly treated)
• Girls who are able and willing to give their agreement to take part (for those under 16), or their formal consent (for those 16 and older), and whose parent or guardian is also willing to give consent
• Girls who are willing to reliably avoid becoming pregnant using non-hormonal methods throughout the study

Who may not be able to join:

• Girls or individuals who are unable to give consent or agreement to participate
• Males (this trial is specific to females)
• Girls whose obesity is caused by a known hormonal disorder or genetic condition
• Girls who have a positive pregnancy test or who are currently breastfeeding
• Girls whose excess male hormones or irregular ovulation appear to be caused by something other than a natural hormonal variation or a condition similar to PCOS
• Girls showing signs of virilisation, such as rapid increase in body or facial hair, voice deepening, or changes to genital anatomy
• Girls with a total testosterone level above 150 ng/dl, which may suggest a hormone-producing tumour in the ovaries or adrenal glands
• Girls with a significantly elevated DHEA-S hormone level (more than 1.5 times the upper limit of the normal range); note that mild elevations may be accepted in girls with excess male hormones or PCOS (confirm with trial site)
• Girls with an early morning 17-hydroxyprogesterone hormone level above 200 ng/dl measured at the right point in the menstrual cycle, which may suggest a condition called congenital adrenal hyperplasia (further testing may be required — confirm with trial site)
• Girls with an abnormal thyroid-stimulating hormone (TSH) level; girls with a stable, well-treated underactive thyroid and a normal TSH level would not be excluded
• Girls with significantly elevated prolactin hormone levels; mild elevations up to 20% above the upper limit of normal may be accepted in girls with excess male hormones or PCOS
• Girls with signs or history suggesting certain hormonal conditions, including Cushing's syndrome, adrenal insufficiency, or acromegaly
• Girls with signs or history suggesting low levels of reproductive hormones from the brain (hypogonadotropic hypogonadism), including those with period loss related to restrictive eating, excessive exercise, or significant psychological stress
• Girls with low red blood cell levels (haematocrit below 36% or haemoglobin below 12 g/dl)
• Girls with severely low platelet counts or low white blood cell counts
• Girls with a previous diagnosis of diabetes, a fasting blood sugar at or above 126 mg/dl, or a haemoglobin A1c at or above 6.5%
• Girls with persistent abnormal liver test results, with some exceptions for mild elevations in certain situations (confirm with trial site)
• Girls with a significant history of heart or lung problems, such as heart failure or asthma requiring regular steroid tablets
• Girls with reduced kidney function (GFR below 60 ml/min/1.73m²)
• Girls with a personal history of breast, ovarian, or uterine cancer
• Girls with a history of any other cancer diagnosis or treatment (except certain common skin cancers) unless they have been confirmed free of disease for at least five years
• Girls with a known allergy to micronised progesterone
• Girls whose body weight is below the 5th percentile for their age (considered underweight)
• Girls weighing less than 25 kg, due to the amount of blood required for the study
• Girls who have taken medications known to affect reproductive hormones, blood sugar, cholesterol, or blood pressure within the past 2 to 3 months — this includes the contraceptive pill, progestins, metformin, steroid tablets, some antipsychotic medications, and stimulant medications such as methylphenidate

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