Actively Recruiting

Early Phase 1
Age: 10Years - 17Years
FEMALE
Healthy Volunteers
NCT00929006

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

913 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

The purpose of this study is two-fold. (1) We will determine if in mid- to late pubertal girls without hyperandrogenism (HA), progesterone (P4) acutely reduces waking luteinizing hormone (LH) frequency to a greater extent than sleep-associated LH frequency. (2) We will determine if in mid- to late pubertal girls with HA, P4 will acutely suppress waking LH frequency to a lesser degree than it does in girls without HA.

CONDITIONS

Official 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

Eligible

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: serum free testosterone within Tanner stage-specific reference range and absence of hirsutism
  • For girls with hyperandrogenism: serum free testosterone above Tanner stage-specific reference range and/or clear evidence of hirsutism
  • General good health except overweight, obesity, hyperandrogenism, and stable treated hypothyroidism
  • Capable of and willing to provide informed assent or consent (adolescents under 16 assent; over 16 consent; parents or guardians consent for all)
  • Willing to strictly avoid pregnancy using reliable non-hormonal methods during the study period
Not Eligible

You will not qualify if you...

  • Unable or incapable of providing informed consent
  • Male sex
  • Obesity caused by known endocrinopathy 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, deepened voice, clitoromegaly
  • Total testosterone above 150 ng/dl suggestive of virilizing tumor
  • DHEA-S greater than 1.5 times upper reference limit (except mild elevations in HA or PCOS)
  • Early morning 17-hydroxyprogesterone above 200 ng/dl in follicular phase (with repeat testing and ACTH stimulation as needed)
  • Abnormal thyroid stimulating hormone unless stable treated hypothyroidism
  • Hyperprolactinemia above 20% of upper normal limit (except mild elevations in HA/PCOS)
  • History or signs of Cushing's syndrome, adrenal insufficiency, or acromegaly
  • History or signs of hypogonadotropic hypogonadism including functional hypothalamic amenorrhea
  • Hematocrit less than 36% or hemoglobin less than 12 g/dl
  • Severe low platelets or white blood count
  • Diagnosis of diabetes or high fasting glucose or hemoglobin A1c
  • Persistent abnormal liver tests except mild bilirubin or mild transaminase elevations
  • Significant heart or lung disease
  • Reduced kidney function with GFR below 60 ml/min/1.73m2
  • Personal history of breast, ovarian, or endometrial cancer
  • Other cancer history unless disease free for 5 years (except certain skin cancers)
  • Allergy to micronized progesterone
  • Body mass index below 5th percentile for age
  • Weight under 25 kg due to blood draw volume
  • Use of medications affecting reproductive, glucose, lipid metabolism, or blood pressure within 2 to 3 months before study start

AI-Screening

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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

CONTACT

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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