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New treatment option for Hyperandrogenism
Official title Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?
ClinicalTrials.gov ID: NCT04723862
What this study is testing
What is Spironolactone?
Spironolactone is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for hyperandrogenism.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine if, in mid- to late pubertal girls with hyperandrogenism (HA), androgen-receptor blockade (spironolactone) alone normalizes sleep-wake luteinizing hormone (LH) pulse frequency (primary endpoint) and overall LH and follicle-stimulating hormone secretion (secondary endpoints).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 17, women only. Healthy volunteers may be eligible.
You may be able to join if
- Mid- to late pubertal adolescent girls as signified by either (a) post-menarcheal status (Tanner breast stages 2-5) or (b) Tanner breast stage of 4...
- Hyperandrogenism, defined as a serum (calculated) free testosterone concentration greater than the Tanner stage-specific reference range and/or...
- General good health (excepting obesity, hyperandrogenism, PCOS, and adequately-treated hypothyroidism)
- Willing to strictly avoid pregnancy with use of reliable non-hormonal methods during the study period.
You likely can't join if
- Inability/incapacity to provide informed consent
- Males will be excluded (hyperandrogenism is unique to females)
- Age \ 17 years (this study is designed to elucidate mechanisms underlying emerging PCOS in mid- to late pubertal adolescent girls
- Post-menarcheal by \> 4 years
- Obesity resulting from a well-defined endocrinopathy, or genetic syndrome
- To ensure that blood withdrawal is within safe limits, weight \< 21.5 kg is an exclusion criterion.
See the full eligibility criteria
- Mid- to late pubertal adolescent girls as signified by either (a) post-menarcheal status (Tanner breast stages 2-5) or (b) Tanner breast stage of 4 or 5 (whether pre-menarcheal or post-menarcheal) ages 10-17 years.
- Hyperandrogenism, defined as a serum (calculated) free testosterone concentration greater than the Tanner stage-specific reference range and/or clinical hirsutism
- General good health (excepting obesity, hyperandrogenism, PCOS, and adequately-treated hypothyroidism)
- Willing to strictly avoid pregnancy with use of reliable non-hormonal methods during the study period.
- Inability/incapacity to provide informed consent
- Males will be excluded (hyperandrogenism is unique to females)
- Age \ 17 years (this study is designed to elucidate mechanisms underlying emerging PCOS in mid- to late pubertal adolescent girls
- Post-menarcheal by \> 4 years
- Obesity resulting from a well-defined endocrinopathy, or genetic syndrome
- To ensure that blood withdrawal is within safe limits, weight \< 21.5 kg is an exclusion criterion.
- Since underweight can alter pulsatile LH secretion, BMI-for-age percentile \< 5 is an exclusion criterion.
- Positive pregnancy test or current lactation. people with a positive pregnancy test will be informed of the result by the screening physician. Under Virginia law, parental notification is not required for minors...
- Evidence for non-physiologic or non-PCOS causes of hyperandrogenism and/or anovulation
- Evidence of virilization (e.g., rapidly progressive hirsutism, deepening of the voice, clitoromegaly)
- Total testosterone \> 150 ng/dl, which suggests the possibility of virilizing ovarian or adrenal tumor.
- DHEA-S elevation \> 1.5 times the upper reference range limit. Mild elevations may be seen in adolescent HA and in PCOS, and will be accepted in these groups.
- Early morning 17-hydroxyprogesterone \> 300 ng/dl measured in the follicular phase, which suggests the possibility of congenital adrenal hyperplasia (if elevated during the luteal phase, the 17-hydroxyprogesterone will...
- Any abnormal TSH concentration will trigger repeat testing. In many cases when TSH is initially abnormal, a repeat TSH will be normal. These people will be permitted to continue study. If TSH remains abnormal on repeat...
- Prolactin concentration \> 30 ng/mL (confirmed on repeat). Mild prolactin elevations may be seen in adolescents and women with HA/PCOS or obesity.
- History and/or physical exam findings suggestive of Cushing's syndrome, adrenal insufficiency, or acromegaly.
- History and/or physical exam findings suggestive of hypogonadotropic hypogonadism (e.g., symptoms of estrogen deficiency) including functional hypothalamic amenorrhea (which may be suggested by a constellation of...
- Persistent hemoglobin \< 11.5 g/dL for non-African American people; hemoglobin \< 11.0 g/dL for African American people (confirmed on repeat). Importantly, documentation of a hemoglobin ≥ 11.0 g/dL for African American...
- Severe thrombocytopenia (platelets \< 50,000 cells/microliter) or leukopenia (total white blood count \< 4,000 cells/microliter)
- Previous diagnosis of diabetes, fasting glucose ≥ 126 mg/dl, or a hemoglobin A1c ≥ 6.5%
- Persistently abnormal sodium or potassium concentration. Bicarbonate concentrations \ 30.
- Liver test abnormalities, with two exceptions: (1) mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome or when the subject's primary care provider provides a presumptive diagnosis of...
- Absolute contraindications to spironolactone use include history of allergy to spironolactone, anuria, acute renal insufficiency, significant impairment of renal excretory function, hyperkalemia, primary adrenal...
- Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure, asthma requiring intermittent systemic corticosteroids, etc.)
- Decreased renal function evidenced by GFR \< 60 ml/min/1.73m2
- History of cancer diagnosis and/or treatment (with the exception of basal cell or squamous cell skin carcinoma) unless they have remained clinically disease free (based on appropriate surveillance) for five years.
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 10 years to 17 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.