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Corticosteroid

Spironolactone for Polycystic Ovary Syndrome (CBS009 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
When the subject is a minor (i.e., age < 18 y), the subject and custodial parents must be willing and able to provide written informed assent and consent, respectively
Screening labs within age-appropriate normal range
Timeline
Screening 3 weeks
Treatment Varies
Follow Up rates of ovulation during weeks 17-32 (on medication) and weeks 33-48 (after medication) compared to weeks 1-16 (baseline, prior to medication)
Awards & highlights

CBS009 Trial Summary

This trial will study whether spironolactone can improve ovulation rates in adolescent girls with androgen excess, which could prevent PCOS and infertility.

Who is the study for?
This trial is for girls aged 13-19 with androgen excess, which can lead to irregular periods and risk of PCOS. They must be within 4-6 years post-menarche, have normal lab results for their age, and not be pregnant or lactating. Participants need to avoid pregnancy using non-hormonal methods during the study.Check my eligibility
What is being tested?
The trial tests if Spironolactone improves ovulation rates in adolescent girls with high levels of male hormones (androgens). It aims to see if early treatment can prevent PCOS development. Girls will take Spironolactone while avoiding hormonal contraceptives.See study design
What are the potential side effects?
Spironolactone may cause menstrual irregularities, breast tenderness, headaches, gastrointestinal issues like nausea or vomiting, dizziness upon standing up too fast due to blood pressure changes, and increased potassium levels.

CBS009 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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If I am under 18, both I and my parents agree to participate.
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My recent lab tests are normal for my age.
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I am committed to using non-hormonal birth control during the study.
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I am 18-19 years old and can sign a consent form.
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I am a girl aged 13-19, with signs of high male hormones, 4-6 years after my first period.

CBS009 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~rates of ovulation during weeks 17-32 (on medication) and weeks 33-48 (after medication) compared to weeks 1-16 (baseline, prior to medication)
This trial's timeline: 3 weeks for screening, Varies for treatment, and rates of ovulation during weeks 17-32 (on medication) and weeks 33-48 (after medication) compared to weeks 1-16 (baseline, prior to medication) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ovulation Rate Changes
Secondary outcome measures
Acne
Hirsutism
Menstrual Regularity Changes

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

CBS009 Trial Design

1Treatment groups
Experimental Treatment
Group I: SpironolactoneExperimental Treatment1 Intervention
16 weeks without medication, then 16 weeks with medication, then 12 months without medication; spironolactone 50 mg tablets: 50-100 mg orally twice daily (1.7-3.3 mg/kg/24 hr)
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?

University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,245,016 Total Patients Enrolled
26 Trials studying Polycystic Ovary Syndrome
1,180 Patients Enrolled for Polycystic Ovary Syndrome
Waterloo FoundationUNKNOWN
3 Previous Clinical Trials
323 Total Patients Enrolled
1 Trials studying Polycystic Ovary Syndrome
158 Patients Enrolled for Polycystic Ovary Syndrome
Christine Burt Solorzano, MDPrincipal Investigator - University of Virginia
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
271 Total Patients Enrolled
7 Trials studying Polycystic Ovary Syndrome
271 Patients Enrolled for Polycystic Ovary Syndrome

Frequently Asked Questions

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

Have other research initiatives explored Spironolactone's efficacy?

"Currently, 28 distinct medical studies are actively researching the efficacy of Spironolactone with 7 trials in Phase 3. While a handful of these clinical investigations originate from Boston, MA, there is an expansive reach with 293 other sites running related research at this time."

Answered by AI

Is it still possible to register for this experiment?

"Affirmative. The clinicaltrials.gov database affirms that this medical trial is currently enrolling new patients, with the initial posting made on December 18th 2019 and the last update being July 28th 2022. A total of 24 participants are required from a single site for full enrollment to be achieved."

Answered by AI

To what medical condition is Spironolactone commonly applied?

"Spironolactone has proven therapeutic effects for primary hyperaldosteronism, as well as cirrhosis of the liver, post-surgery conditions, and acne."

Answered by AI

What are the qualifying criteria for participating in this trial?

"This clinical trial is recruiting 24 adolescents aged between 13 to 19 with sclerocystic ovaries. To be eligible, participants must exhibit hirsutism and/or heightened Tanner stage-specific free testosterone concentrations that have been present for at least 4 years since menarche, possess age appropriate laboratory results and agree to not become pregnant during the duration of the study (by employing non-hormonal contraceptive methods). Additionally, volunteers over 18 need to provide written informed consent while those under 18 require both their parents' written assent as well as their own written consent."

Answered by AI

How many individuals are currently collaborating in this experiment?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, which began on December 18th 2019 and was last updated on July 28th 2022, is currently searching for 24 volunteers from one particular medical center."

Answered by AI

Does this research encompass geriatric participants?

"Patients aged between 13 and 19 are eligible for enrollment in this trial. There is a total of 271 studies available to minors, while 642 trials have been designed with those over 65 years old in mind."

Answered by AI
~2 spots leftby Sep 2024