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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

Screening labs within age-appropriate normal range

Willingness to strictly avoid pregnancy (using non-hormonal methods) during the time of study

Must not have

Cushing syndrome

Inability to comprehend what will be done during the study or why it will be done

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

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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 a girl aged 13-19, with signs of high male hormones, 4-6 years after my first period.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with Cushing syndrome.

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I understand what the study involves and why it's being done.

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I have never had a menstrual period by the age of 16.

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My obesity is caused by a genetic condition like Prader-Willi syndrome.

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I am either younger than 13 or older than 19 years old.

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I have or might have congenital adrenal hyperplasia based on my hormone levels.

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I haven't taken steroids, birth control, diabetes, or certain mental health meds in the last 3 months.

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I am a girl with high androgen levels.

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I am a girl who is between 3 and 7 years after my first period.

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I have diabetes.

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I experienced breast development before I was 7 years old.

Timeline

Screening ~ 3 weeks3 visits

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)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ovulation Rate Changes

Secondary study objectives

Acne

Hirsutism

Menstrual Regularity Changes

Side effects data

From 2022 Phase 4 trial • 79 Patients • NCT02169089

Hypotension

Hyperkalemia

Infection

Diabetes related

Surgical

Chest pain/discomfort

Breast tenderness/Gynecomastia

100%

80%

60%

40%

20%

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.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 14Eligibility criteria met