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Antiandrogen

Spironolactone for Hyperandrogenism in Pubertal Girls (CBS010 Trial)

Phase < 1
Recruiting
Led By Christine Burt Solorzano, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing to strictly avoid pregnancy with use of reliable non-hormonal methods during the study period
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.
Must not have
Inability/incapacity to provide informed consent
Weight < 21.5 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 2 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Summary

This trial is testing if a medication can normalize hormone levels in girls who are experiencing too much androgen.

Who is the study for?
This trial is for mid to late pubertal girls aged 10-17 with hyperandrogenism, which could be high testosterone levels or excessive hair growth. They should be in good health overall and agree to avoid pregnancy using non-hormonal methods during the study.
What is being tested?
The trial tests if Spironolactone, a medication that blocks androgen receptors, can normalize sleep-wake luteinizing hormone pulse frequency in these girls. The study also looks at its effects on other hormones like LH and FSH compared to a placebo.
What are the potential side effects?
Spironolactone may cause side effects such as menstrual irregularities, breast tenderness, headaches, gastrointestinal issues, dizziness or fatigue. It might also affect electrolyte balance leading to changes in potassium levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am committed to using non-hormonal birth control methods during the study.
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I am a girl aged 10-17, either after my first period or in the later stages of puberty.
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I am committed to using non-hormonal birth control during the study.
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I am a girl aged 10-17, either after my first period or in mid to late puberty.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to understand or sign the consent form.
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I weigh less than 21.5 kg.
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I am younger than 10 or older than 17 years old.
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My obesity is due to a hormonal disorder or genetic condition.
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I am not eligible for this trial because I am male.
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My kidney function is reduced with a GFR under 60.
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I have signs of increased male traits.
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I might have Cushing's syndrome, adrenal insufficiency, or acromegaly based on my symptoms or doctor's exam.
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I have diabetes or my blood sugar or A1c levels are high.
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I cannot take spironolactone due to severe adverse reactions.
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I have a serious heart or lung condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Sleep-Associated Luteinizing Hormone (LH) Pulse Frequency Between Admission With Spironolactone Versus Placebo
Secondary study objectives
Luteinizing hormone
Change in Wake-Associated Luteinizing Hormone (LH) Pulse Frequency Between Admission With Spironolactone Versus Placebo

Side effects data

From 2022 Phase 4 trial • 79 Patients • NCT02169089
8%
Hypotension
5%
Hyperkalemia
5%
Infection
5%
Diabetes related
3%
Surgical
3%
Chest pain/discomfort
3%
Breast tenderness/Gynecomastia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spironolactone
Placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SpironolactoneExperimental Treatment1 Intervention
Prior to the first or second admission (randomly determined), participants will be pretreated for 2 weeks with spironolactone (50 mg twice daily).
Group II: PlaceboPlacebo Group1 Intervention
Prior to the first or the second admission (randomly determined), participants will be pretreated for 2 weeks with placebo (twice daily).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spironolactone
FDA approved

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,055 Previous Clinical Trials
2,731,854 Total Patients Enrolled
University of VirginiaLead Sponsor
782 Previous Clinical Trials
1,315,670 Total Patients Enrolled
Christine Burt Solorzano, MDPrincipal Investigator - University of Virginia Center for Research in Reproduction
UVA Child Development & Rehabilitation Center, University of Virginia Medical Center
University Of Virginia School Of Medicine (Medical School)
Children'S Hosp Of L A (Residency)
7 Previous Clinical Trials
263 Total Patients Enrolled

Media Library

Spironolactone (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT04723862 — Phase < 1
Androgen Syndrome Research Study Groups: Spironolactone, Placebo
Androgen Syndrome Clinical Trial 2023: Spironolactone Highlights & Side Effects. Trial Name: NCT04723862 — Phase < 1
Spironolactone (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04723862 — Phase < 1
Androgen Syndrome Patient Testimony for trial: Trial Name: NCT04723862 — Phase < 1
~7 spots leftby Oct 2025
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