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Corticosteroid

Spironolactone for Polycystic Ovary Syndrome

N/A

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

Overweight(>85th BMI%) females

Be younger than 65 years old

Must not have

Morning cortisol < 3 µg/dL or history of Cushing syndrome or adrenal insufficiency

Previous diagnosis of diabetes, fasting glucose ≥126 mg/dL, or a hemoglobin A1c ≥6.5%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

This trial will determine if spironolactone can reduce androgen production in obese girls with androgen excess.

Who is the study for?

This trial is for overweight girls aged 7-18 in early to late puberty with excess androgen levels. They must have normal lab results, except for specific hormonal imbalances related to obesity. Girls who are pregnant, lactating, or have certain medical conditions like Cushing syndrome or diabetes cannot participate.

What is being tested?

The study tests if a 12-week course of Spironolactone can lower the production of androgens (male hormones) by the ovaries and adrenal glands in pubertal girls with obesity-related hormone issues.

What are the potential side effects?

Spironolactone may cause menstrual irregularities, breast tenderness, dizziness, gastrointestinal upset, increased potassium levels in blood which could affect heart rhythm, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am a female and my BMI is above the 85th percentile.

Exclusion Criteria

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

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My morning cortisol is low or I have had Cushing syndrome or adrenal issues.

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I have diabetes or my blood sugar or A1c levels are high.

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I haven't taken any medications that could affect my reproductive system or blood sugar levels in the last 3 months.

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

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I have a serious heart or lung condition.

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My BMI is below the 5th percentile for my age.

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I am either younger than 7 or older than 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

No Placebo-Only Group

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

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

1Treatment groups

Experimental Treatment

Group I: spironolactoneExperimental Treatment1 Intervention

12 weeks spironolactone with pre- and post-intervention dexamethasone, and ACTH to perform standardized adrenal stimulation testing; dexamethasone and rhCG to perform standardized ovarian stimulation testing

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Spironolactone

FDA approved

0 / 8Eligibility criteria met