Progesterone and LH Pulse Frequency in Pubertal Girls
This study is looking at how a natural hormone called micronized progesterone suspension affects luteinizing hormone (LH) pulse frequency in girls going through puberty. LH is a hormone that plays a key role in puberty and reproduction. Researchers want to see if progesterone reduces LH pulse frequency differently when girls are awake versus asleep. They also want to compare this effect in girls with and without hyperandrogenism (HA), a condition where the body makes too many male hormones. The study will include girls aged 10 to 17 who are in mid- to late puberty. The main goal is to measure changes in LH pulse frequency during two separate study visits.
- Study design
- This is a randomized, placebo-controlled, double-blinded crossover study with a planned enrollment of 36 participants.
- What's involved
- You would have two 18-hour overnight stays in a Clinical Research Unit, at least two months apart. During these stays, blood samples will be taken every 10 minutes through an IV.
- 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, with the second occurring at least two months after the first.
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NCT00929006
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
Recruiting
EARLY_PHASE1Ages 10–17InterventionalBasic scienceUniversity of VirginiaInvestigator-initiated
~36 participants
Updated 2025-08-05 on ClinicalTrials.gov
What's tested:Micronized progesterone suspensionPlacebo
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 M Burt Solorzano, MD · PRINCIPAL_INVESTIGATOR · University of Virginia
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)
For girls without hyperandrogenism: serum (calculated) free testosterone concentration within the Tanner stage-specific reference range and the absence of hirsutism
For girls with hyperandrogenism: 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: Mild prolactin elevations may be seen in 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.)
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 such girls.
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.
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 pulse frequency