Hyperandrogenemia and Altered Day-night LH Pulse Patterns

ConditionsHyperandrogenism Polycystic Ovary Syndrome Puberty

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexFemale

Age10-17

SponsorUniversity of Virginia

About this trial

The purpose of this study is to determine if, in mid- to late pubertal girls with hyperandrogenism, androgen-receptor blockade (spironolactone) improves the ability of progesterone to acutely reduce waking luteinizing hormone pulse frequency (primary endpoint).

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)

Hyperandrogenism, defined as a 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)

Capable of and willing to provide informed assent (adolescents under age 16 years) and/or consent (adolescents over age 16 years; custodial parents or guardians of all adolescent volunteers)

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
Drug
Micronized progesterone 0.8 mg/kg at 0700, 1500, 2300 and 0700 h. Progesterone is a natural hormone.
Spironolactone
Drug
Spironolactone is an androgen-receptor blocker commonly used (off-label) for hyperandrogenism. The spironolactone dose will be 50 mg taken orally twice daily (for two weeks before admission to the Clinical Research Unit).
Placebo
Drug
Placebo contains only inert ingredients and is not expected to exert any direct physiological effects.

Treatment groups

32 Participants

are divided into 2 treatment groups

Group A: SpironolactoneExperimental treatment 2 interventions

Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

Luteinizing hormone (LH) pulse frequency

LH pulse frequency while awake vs. while asleep

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov

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