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

ConditionsPuberty 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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

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

Treatment groups

36 Participants

are divided into 2 treatment groups

Group A: Micronized progesterone suspensionExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Luteinizing hormone (LH) pulse frequency

LH pulse frequency while awake vs. while asleep pulse frequency

Time frame

During first CRU admission and during the second CRU admission (which occurs at least 2 months after the first)

Sponsors and contacts

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University of Virginia

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov

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