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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 2 months
Awards & highlights

CBS010 Trial 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.Check my eligibility
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.See study design
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.

CBS010 Trial 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 generally healthy, though I may have obesity, PCOS, high androgen levels, or treated hypothyroidism.
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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.

CBS010 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Sleep-Associated Luteinizing Hormone (LH) Pulse Frequency Between Admission With Spironolactone Versus Placebo
Secondary outcome measures
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%
Diabetes related
5%
Hyperkalemia
5%
Infection
3%
Breast tenderness/Gynecomastia
3%
Chest pain/discomfort
3%
Surgical
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spironolactone
Placebo

CBS010 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
1,953 Previous Clinical Trials
2,660,448 Total Patients Enrolled
University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,245,008 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment engaging elderly participants?

"The eligibility criteria for this clinical trial stipulates that participants ought to be between the ages of 10 and 17."

Answered by AI

What criteria must prospective participants meet to be eligible for this research?

"The trial is recruiting 32 adolescents aged 10 to 17 with hyperandrogenism. To receive consideration, applicants must be capable of abstaining from pregnancy via non-hormonal methods during the study period; they should also demonstrate mid-to late pubertal development (as indicated by Tanner breast stages 2-5), hyperandrogenism through serum free testosterone concentrations exceeding specific reference ranges and/or clinical hirsutism; finally, participants need to generally possess good health barring obesity, PCOS and hypothyroidism properly managed with medication."

Answered by AI

What other scientific investigations have been conducted with respect to Spironolactone?

"Currently, 29 medical studies are exploring the benefits of Spironolactone with 7 trials in their final stage. While Boston Massachusetts is a hub for these experiments, there are 294 sites conducting clinical research into this medication."

Answered by AI

Is participation in this research open to the public?

"Per clinicaltrials.gov, recruitment for this study is ongoing since its original posting on November 12th 2021 and modified as recently as July 28th 2022."

Answered by AI

What conditions has Spironolactone been shown to be an effective remedy for?

"Spironolactone is traditionally used to remedy primary hyperaldosteronism, yet it may also be effective in cases of cirrhosis, post-surgical care, and acne."

Answered by AI

How many participants have been recruited to take part in this research endeavor?

"Affirmative. According to clinicaltrials.gov, recruitment for this medical trial is ongoing; it was initially posted on November 12th 2021 and most recently updated on July 28th 2022. Specifically, 32 volunteers need to be sourced from a single site."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
What site did they apply to?
Center for Research in Reproduction, University of Virginia
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I've tried metformin and birth control in the past, but my body became stagnant with them.
PatientReceived 1 prior treatment
~13 spots leftby Oct 2025