Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?

Recruiting Early Phase 1 Interventional Study
Hyperandrogenism Polycystic Ovary Syndrome Puberty
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At a Glance
Age
10 – 17
Sex
Female
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
32 (estimated)
Sponsor
University of Virginia · Other
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About This Trial

The purpose of this study is to determine if, in mid- to late pubertal girls with hyperandrogenism (HA), androgen-receptor blockade (spironolactone) alone normalizes sleep-wake luteinizing hormone (LH) pulse frequency (primary endpoint) and overall LH and follicle-stimulating hormone secretion (secondary endpoints).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Mid- to late pubertal adolescent girls as signified by either (a) post-menarcheal status (Tanner breast stages 2-5) or (b) Tanner breast stage of 4 or 5 (whether pre-menarcheal or post-menarcheal) ages 10-17 years. * Hyperandrogenism, defined as a serum (calculated) free testo…
Contacts

Melissa Gilrain, BS

434-243-6911

mg7zb@hscmail.mcc.virginia.edu

CONTACT

Christine Burt Solorzano, MD

434-243-6911

cmb6w@hscmail.mcc.virginia.edu

CONTACT