Progesterone Treatment for Pubertal Girls with Hormone Issues

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

Recruiting Early Phase 1 Interventional Study
Puberty Hyperandrogenism
Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
10 – 17
Sex
Female
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
36 (estimated)
Sponsor
University of Virginia · Other
Who this trial is looking for

This trial is looking for mid- to late pubertal girls with or without hormone issues called hyperandrogenism. Participants will take progesterone and undergo tests to measure certain hormone levels during waking and sleeping hours.

Are You a Good Fit for This Trial?
Must not be taking Hormonal contraceptivesMetforminGlucocorticoidsAntipsychoticsStimulants
Rules you out Cushing's syndromeAdrenal insufficiencyAcromegalyHypogonadotropic hypogonadism

You may be able to join if

  • I am a mid- to late pubertal girl and not more than 2 years after my first period.
  • I am in good health except for being overweight or having hyperandrogenism.
  • I can provide consent if I’m over 16, or assent if I’m younger.
  • I will use reliable non-hormonal methods to avoid pregnancy during the trial.

You may not be able to join if

  • I cannot provide informed consent.
  • I am male.
  • I have a positive pregnancy test or am currently breastfeeding.
  • I have a significant history of heart or lung problems.
  • I have had specific cancers or treatments in the past.
  • I have a personal history of severe menstrual issues or hormonal disorders.
  • I weigh less than 25 kg.
  • I have had severe blood-related issues like low platelets.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 hirsutis…
Contacts

Melissa Gilrain

434-243-6911

pcos@virginia.edu

CONTACT