Does Spironolactone Normalize Sleep-wake Luteinizing Hormone (LH) Pulse Frequency in Pubertal Girls With Hyperandrogenism? (CBS010)

Who is this study for? Patients with Hyperandrogenism, Polycystic Ovary Syndrome
What treatments are being studied? Drug: Spironolactone
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 10
Maximum Age: 17
Healthy Volunteers: t
View:

• 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 testosterone concentration greater than the Tanner stage-specific reference range and/or clinical hirsutism

• General good health (excepting obesity, hyperandrogenism, PCOS, and adequately-treated hypothyroidism)

• Willing to strictly avoid pregnancy with use of reliable non-hormonal methods during the study period.

Locations
United States
Virginia
Center for Research in Reproduction, University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Melissa Gilrain, BS
mg7zb@hscmail.mcc.virginia.edu
434-243-6911
Backup
Christine Burt Solorzano, MD
cmb6w@hscmail.mcc.virginia.edu
434-243-6911
Time Frame
Start Date: 2021-11-12
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 32
Treatments
Experimental: Spironolactone
Prior to the first or second admission (randomly determined), participants will be pretreated for 2 weeks with spironolactone (50 mg twice daily).
Placebo_comparator: Placebo
Prior to the first or the second admission (randomly determined), participants will be pretreated for 2 weeks with placebo (twice daily).
Authors
Su H Kim
Related Therapeutic Areas
Intersex
Polycystic Ovary Syndrome
Ovarian Cysts
Sponsors
Leads: University of Virginia
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov

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