Spironolactone for Hyperandrogenism in Pubertal Girls
This study is looking at whether spironolactone, a medication commonly used to block certain hormones, can help normalize sleep-wake luteinizing hormone (LH) pulse frequency in pubertal girls with hyperandrogenism. Hyperandrogenism means having higher-than-normal levels of male hormones, which can be linked to conditions like Polycystic Ovary Syndrome (PCOS). The study will compare spironolactone to a placebo (an inactive substance) to see if spironolactone changes LH pulse frequency. Girls aged 10-17 who are in mid- to late puberty and have hyperandrogenism (based on blood tests or clinical signs) can join. The study aims to see if spironolactone can reduce LH pulse frequency. The current recruitment status is unclear.
- Study design
- This is a randomized, placebo-controlled, double-blinded crossover study involving 32 participants. Participants will receive both spironolactone and placebo at different times.
- What's involved
- You would take spironolactone or placebo for two weeks before each of two hospital admissions. During each admission, blood samples will be taken every 10 minutes for about 15 hours, and sleep studies will be performed.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured between baseline and 2 months.
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NCT04723862
Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?
Recruiting
EARLY_PHASE1Ages 10–17InterventionalBasic scienceUniversity of VirginiaInvestigator-initiated
~32 participants
Updated 2025-08-05 on ClinicalTrials.gov
What's tested:SpironolactonePlacebo
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Sleep-Associated Luteinizing Hormone (LH) Pulse Frequency Between Admission With Spironolactone Versus Placebo
Measured over Baseline to 2 months
Conditions
Where it's being run
1 sites across 1 statesVirginia1
Study leadership
- Christine Burt Solorzano, MD · PRINCIPAL_INVESTIGATOR · University of Virginia Center for Research in Reproduction
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
Exclusion
Inability/incapacity to provide informed consent
Males will be excluded (hyperandrogenism is unique to females)
Age \< 10 or \> 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. Subjects 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. However, the screening physician will encourage the subject to tell her parent(s). We will counsel the adolescent about the importance of appropriate prenatal care/counseling. We will offer appropriate follow-up at the Teen Health Clinic at UVA and/or encourage the adolescent to secure prompt care via their primary care physician's office.
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 be repeated during the follicular phase). NOTE: if a 17-hydorxyprogesterone \> 300 ng/dl is confirmed on repeat testing, an ACTH stimulated 17-hydroxyprogesterone \< 1000 ng/dl performed by the subject's personal physician will be required for study participation.
Any abnormal TSH concentration will trigger repeat testing. In many cases when TSH is initially abnormal, a repeat TSH will be normal. These subjects will be permitted to continue study. If TSH remains abnormal on repeat testing, the subject will be referred to her primary medical provider. In some cases, a participant's primary medical provider will elect to simply observe a mildly low (\> 0.1) or mildly elevated (\< 10) if stable. In such cases, we will accept a TSH between 0.3 and 7 (inclusive) if it has remained stable for at least 6 months-such TSH values are exceedingly unlikely to influence the central reproductive axis or to influence the risks of the study. Notably, subjects with reasonably-treated primary hypothyroidism-reflected by TSH values between 0.3 and 7-on a stable dose of thyroid hormone (i.e., same dose for at least 2 months) will not be excluded.
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 symptoms including restrictive eating patterns, excessive exercise, psychological stress, etc.)
Persistent hemoglobin \< 11.5 g/dL for non-African American subjects; hemoglobin \< 11.0 g/dL for African American subjects (confirmed on repeat). Importantly, documentation of a hemoglobin ≥ 11.0 g/dL for African American subjects or ≥ 11.5 g/dL for non-African American subjects in the month prior to the CRU admission is required for frequent sampling protocol in the CRU.
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 \< 20 or \> 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 Gilbert's syndrome and has no plans for further work-up; (2) mild transaminase (ALT, AST) elevations may be seen in obese/HA/PCOS girls, so stable elevations \< 1.5 times the upper limit of normal will be accepted in this group.
Absolute contraindications to spironolactone use include history of allergy to spironolactone, anuria, acute renal insufficiency, significant impairment of renal excretory function, hyperkalemia, primary adrenal insufficiency (Addison's disease), and concomitant use of eplerenone
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.
What this trial measures
- Change in Sleep-Associated Luteinizing Hormone (LH) Pulse Frequency Between Admission With Spironolactone Versus PlaceboBaseline to 2 months
The sleep-associated (22:00 h - 07:00 h) luteinizing hormone (LH) pulse frequency data from the spironolactone and placebo admissions will be analyzed via a hierarchical linear mixed model (HLMM). Sleep-associated LH pulse frequency will be compared between the spironolactone admission and the placebo admission via a linear contrast of the HLMM least squares LH pulse frequency means.