Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT00929006
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Hyperandrogenism
  • Puberty

Eligibility Criteria

Sex
FEMALE
Age
10 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • Micronized progesterone suspension — DRUG
    Micronized progesterone 0.8 mg/kg at 0700, 1500, 2300 and 0700 h. Progesterone is a natural hormone.
  • Placebo — DRUG
    Placebo contains only inert ingredients and is not expected to exert any direct physiological effects

Study Details

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.

Key Dates

Start date
Jun 30, 2008
Status verified
Jul 2025
Primary completion
Oct 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Micronized progesterone suspension
    Micronized progesterone 0.8 mg/kg at 0700, 1500, 2300 and 0700 h. Progesterone is a natural hormone.
  • Placebo Comparator: Placebo
    Placebo contains only inert ingredients and is not expected to exert any direct physiological effects.

Primary Outcome Measure

Luteinizing hormone (LH) pulse frequency [ Time Frame: During first CRU admission and during the second CRU admission (which occurs at least 2 months after the first) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22908
Melissa Gilrain
[email protected]
434-243-6911
Christopher McCartney, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Virginia· Charlottesville, VA

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