Hyperandrogenism and LH Pulse Patterns in Adolescent Girls
This study is for adolescent girls aged 10-17 who are in mid- to late puberty and have hyperandrogenism (higher-than-normal male hormones, which can cause symptoms like excess hair growth). The study aims to see if spironolactone, a drug often used to block male hormones, helps micronized progesterone (a natural hormone) reduce the frequency of luteinizing hormone (LH) pulses. LH is a hormone that plays a role in puberty and reproduction. Participants will receive either spironolactone or a placebo (an inactive substance) for two weeks, followed by micronized progesterone. The main goal is to measure how often LH pulses occur during two separate hospital stays. The study is currently unclear on its recruitment status and plans to enroll 32 participants.
- Study design
- This is a randomized, placebo-controlled, double-blinded crossover study involving 32 participants. This means participants are randomly assigned to receive either the study drug or placebo, neither you nor the study staff will know which you are receiving, and you will receive both treatments at different times.
- What's involved
- You will have two 18-hour stays in a Clinical Research Unit, separated by at least two months. Before each stay, you will take either spironolactone or placebo orally twice daily for two weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, LH pulse frequency, is measured during the first and second Clinical Research Unit admissions, which are at least two months apart.
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NCT03068910
Hyperandrogenemia and Altered Day-night LH Pulse Patterns
Recruiting
EARLY_PHASE1Ages 10–17InterventionalBasic scienceUniversity of VirginiaInvestigator-initiated
~32 participants
Updated 2025-08-05 on ClinicalTrials.gov
What's tested:Micronized progesteroneSpironolactonePlacebo
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Luteinizing hormone (LH) pulse frequency
Measured over During first CRU admission and during the second CRU admission (which occurs at least 2 months after the first)
Conditions
Where it's being run
1 sites across 1 statesVirginia1
Study leadership
- Christine Burt Solorzano, M.D. · 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 girl (at least Tanner breast stage 3, but no more than 2 years postmenarcheal)
Hyperandrogenism, defined as a serum (calculated) free testosterone concentration greater than the Tanner stage-specific reference range and/or unequivocal evidence for hirsutism
General good health (excepting overweight, obesity, hyperandrogenism, and adequately-treated hypothyroidism)
Capable of and willing to provide informed assent (adolescents under age 16 years) and/or consent (adolescents over age 16 years; custodial parents or guardians of all adolescent volunteers)
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)
Obesity resulting from a well-defined endocrinopathy or genetic syndrome
Positive pregnancy test or current lactation
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 \> 200 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-hydroxyprogesterone \> 200 ng/dl is confirmed on repeat testing, an ACTH stimulated 17-hydroxyprogesterone \< 1000 ng/dl will be required for study participation.
Abnormal thyroid stimulating hormone (TSH): Note that subjects with stable and adequately treated primary hypothyroidism, reflected by normal TSH values, will not be excluded.
Hyperprolactinemia \> 20% higher than the upper limit of normal. Mild prolactin elevations may be seen in adolescents and women with HA/PCOS, and elevations within 20% higher than the upper limit of normal will be accepted in this group.
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 hematocrit \< 36% and hemoglobin \< 12 g/dl.
Severe thrombocytopenia (platelets \< 50,000 cells/microliter) or leukopenia (total white blood count \< 4,000 cells/microliter)
Previous diagnosis of diabetes, fasting glucose \> or = 126 mg/dl, or a hemoglobin A1c \> or = 6.5%
Persistent liver panel abnormalities, with two exceptions. Mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome. Also, mild transaminase elevations may be seen in obesity/HA/PCOS; therefore, elevations \< 1.5 times the upper limit of normal will be accepted in this group.
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
A personal history of breast, ovarian, or endometrial cancer
History of any other 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
History of allergy to micronized progesterone or spironolactone
Body mass index (BMI)-for-age percentile \< 5% (underweight)
Due to the amount of blood being drawn, adolescent volunteers with body weight \< 25 kg will be excluded.
Restrictions on use of other drugs or treatments: No medications known to affect the reproductive system, glucose metabolism, lipid metabolism, or blood pressure can be taken in the 2 months prior to the screening visit and in the 3 months prior to the start of the study medications. Such medications include oral contraceptive pills, progestins, metformin, systemic glucocorticoids, some antipsychotic medications, and sympathomimetics/stimulants (e.g., methylphenidate).
What this trial measures
- Luteinizing hormone (LH) pulse frequencyDuring first CRU admission and during the second CRU admission (which occurs at least 2 months after the first)
LH pulse frequency while awake vs. while asleep