Progesterone-Mediated Inhibition of the GnRH Pulse Generator: Differential Sensitivity as a Function of Sleep Status.
Su Hee Kim, Jessica A Lundgren, Ruchi Bhabhra...
https://pubmed.ncbi.nlm.nih.gov/29300925Actively Recruiting
Early Phase 1
Age: 10Years - 17Years
FEMALE
Healthy Volunteers
ID00929006
Study to Assess Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
Led by University of Virginia · Updated on 2025-08-05
36
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
University of Virginia
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how progesterone affects luteinizing hormone (LH) pulse frequency during waking and sleep periods in mid- to late pubertal girls, both with and without hyperandrogenism (HA). The study aims to find out if progesterone reduces waking LH pulse frequency more than sleep-associated LH pulse frequency in girls without HA, and whether this effect is less in girls with HA. The study is a randomized, placebo-controlled, double-blind crossover trial involving mid- to late pubertal girls at Tanner breast stage 3 or higher but no more than 2 years after menarche. Participants will attend two 18-hour clinical research unit admissions across separate menstrual cycles, receiving either oral micronized progesterone (0.8 mg/kg at 7 AM, 3 PM, 11 PM, and 7 AM) or placebo. Blood samples will be collected every 10 minutes overnight to measure LH pulses and other hormones. After at least two months, participants will switch treatments for the second admission. Participants will be closely monitored throughout the study with frequent blood tests to characterize LH secretion patterns. The main measure is LH pulse frequency while awake, with sleep LH pulse frequency as a secondary measure. The study includes detailed hormone analysis and statistical modeling to compare effects between girls with and without HA. The total participation includes two inpatient admissions separated by at least two months.
CONDITIONS
Brief Title
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
Who Can Participate
Age: 10Years - 17Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Mid- to late pubertal adolescent girl (at least Tanner breast stage 3, but no more than 2 years postmenarcheal)
- For girls without hyperandrogenism: free testosterone within Tanner stage-specific range and no hirsutism
- For girls with hyperandrogenism: free testosterone above Tanner stage-specific range and/or clear hirsutism
- General good health except overweight, obesity, hyperandrogenism, or well-treated hypothyroidism
- Able and willing to give informed assent or consent
- Willing to avoid pregnancy with reliable non-hormonal methods during the study
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Male gender
- Obesity due to known endocrine or genetic syndrome
- Positive pregnancy test or currently breastfeeding
- Non-physiologic or non-PCOS causes of hyperandrogenism or anovulation
- Signs of virilization such as rapidly worsening hirsutism or voice changes
- Total testosterone above 150 ng/dl suggesting possible tumor
- DHEA-S elevation more than 1.5 times upper limit, except mild elevation in HA/PCOS
- Early morning 17-hydroxyprogesterone above 200 ng/dl (with follow-up testing if needed)
- Abnormal thyroid stimulating hormone except stable, treated hypothyroidism
- Mildly elevated prolactin within 20% above normal accepted in HA/PCOS
- History or signs of Cushing's syndrome, adrenal insufficiency, or acromegaly
- History or signs of hypogonadotropic hypogonadism including functional hypothalamic amenorrhea
- Low hematocrit (below 36%) or hemoglobin (below 12 g/dl)
- Severe low platelets or white blood cell count
- Diabetes diagnosis or high fasting glucose or hemoglobin A1c
- Persistent liver abnormalities except mild bilirubin or mild transaminase elevation
- Significant cardiac or lung problems such as heart failure or steroid-dependent asthma
- Reduced kidney function with GFR below 60 ml/min/1.73m2
- Personal history of breast, ovarian, or endometrial cancer
- Other cancers unless disease free for 5 years except some skin cancers
- Allergy to micronized progesterone
- BMI-for-age below 5th percentile (underweight)
- Body weight under 25 kg
- Use of certain medications affecting hormones, glucose, lipids, or blood pressure within 2-3 months prior to study start
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Each treatment period lasts approximately 18 hours, with two treatment admissions separated by at least 2 months
Participants receive either micronized progesterone or placebo in a randomized, double-blinded crossover design, with dosing at 0700, 1500, 2300, and 0700 h during each Clinical Research Unit admission. Blood samples are collected every 10 minutes from 1800 to 1200 h to measure hormone levels.
2 Clinical Research Unit admissions of 18 hours each, separated by at least 2 months
Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
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Research Team
M
Melissa Gilrain
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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