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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
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 belowSelect...
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:Select...
My morning cortisol is low or I have had Cushing syndrome or adrenal issues.
Select...
I have diabetes or my blood sugar or A1c levels are high.
Select...
I haven't taken any medications that could affect my reproductive system or blood sugar levels in the last 3 months.
Select...
I understand what the study involves and why it's being done.
Select...
I have a serious heart or lung condition.
Select...
My BMI is below the 5th percentile for my age.
Select...
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
Treatment Details
Side effects data
From 2022 Phase 4 trial • 79 Patients • NCT021690898%
Hypotension
5%
Infection
5%
Hyperkalemia
5%
Diabetes related
3%
Surgical
3%
Chest pain/discomfort
3%
Breast tenderness/Gynecomastia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spironolactone
Placebo
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
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
771 Previous Clinical Trials
1,284,277 Total Patients Enrolled
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
275 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant or breastfeeding.My morning cortisol is low or I have had Cushing syndrome or adrenal issues.Your DHEAS levels are higher than what is considered normal for your age, but slightly higher levels may be accepted for certain medical conditions like PCOS and adolescent Hyperandrogenemia.I have a history of congenital adrenal hyperplasia or high levels of 17-hydroxyprogesterone.I have diabetes or my blood sugar or A1c levels are high.My thyroid function is abnormal, but if treated and stable, I can still join.My liver tests are abnormal, but I may have mild bilirubin elevations due to Gilbert's syndrome or being overweight.I haven't taken any medications that could affect my reproductive system or blood sugar levels in the last 3 months.My blood levels are low, and I'm willing to take iron supplements if needed.My blood tests are mostly normal, though I may have slight changes due to being overweight.I understand what the study involves and why it's being done.Your blood tests show abnormal levels of sodium, potassium, bicarbonate, or creatinine.I have a serious heart or lung condition.My BMI is below the 5th percentile for my age.My testosterone level is above 150 ng/dL, indicating a possible tumor.Your testosterone levels are very high compared to other people your age.I am either younger than 7 or older than 18 years old.I am between 7 and 18 years old, experiencing puberty.Your prolactin levels are higher than normal, but not too high if you are an overweight girl.I am a female and my BMI is above the 85th percentile.Showing physical characteristics of males.
Research Study Groups:
This trial has the following groups:- Group 1: spironolactone
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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