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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age10-17
SponsorUniversity of Virginia

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 in girls without HA.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Micronized progesterone suspension
  • Placebo

Treatment groups

36 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Virginia

Lead sponsor

National Institutes of Health (NIH)

Collaborator