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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.
Must not have
Inability/incapacity to provide informed consent
Weight < 21.5 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 2 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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 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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to understand or sign the consent form.
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I weigh less than 21.5 kg.
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I am younger than 10 or older than 17 years old.
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My obesity is due to a hormonal disorder or genetic condition.
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I am not eligible for this trial because I am male.
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My kidney function is reduced with a GFR under 60.
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I have signs of increased male traits.
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I might have Cushing's syndrome, adrenal insufficiency, or acromegaly based on my symptoms or doctor's exam.
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I have diabetes or my blood sugar or A1c levels are high.
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I cannot take spironolactone due to severe adverse reactions.
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I have a serious heart or lung condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 2 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Sleep-Associated Luteinizing Hormone (LH) Pulse Frequency Between Admission With Spironolactone Versus Placebo
Secondary study objectives
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 • NCT021690898%
Hypotension
5%
Hyperkalemia
5%
Infection
5%
Diabetes related
3%
Surgical
3%
Chest pain/discomfort
3%
Breast tenderness/Gynecomastia
100%
80%
60%
40%
20%
0%
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.
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
2,067 Previous Clinical Trials
2,747,432 Total Patients Enrolled
University of VirginiaLead Sponsor
785 Previous Clinical Trials
1,316,414 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am committed to using non-hormonal birth control methods during the study.Your total testosterone level is higher than 150 ng/dl.I have symptoms or a diagnosis of low testosterone due to pituitary or hypothalamic causes.I am a girl aged 10-17, either after my first period or in the later stages of puberty.You are pregnant or currently breastfeeding.I weigh less than 21.5 kg.I am younger than 10 or older than 17 years old.My obesity is due to a hormonal disorder or genetic condition.I am unable to understand or sign the consent form.I am not eligible for this trial because I am male.Your weight for your age is in the lowest 5% compared to other kids your age.I have been diagnosed or treated for cancer before.Your DHEA-S levels are more than 1.5 times the normal range.My kidney function is reduced with a GFR under 60.My irregular periods or excess male hormones are not due to PCOS.You have high levels of testosterone in your blood or show signs of excessive hair growth.Your 17-hydroxyprogesterone level is higher than 300 ng/dl in the early morning.I am generally healthy, though I may have obesity, PCOS, high androgen levels, or treated hypothyroidism.I have signs of increased male traits.I have had my first menstrual period more than 4 years ago.I might have Cushing's syndrome, adrenal insufficiency, or acromegaly based on my symptoms or doctor's exam.I have diabetes or my blood sugar or A1c levels are high.I am committed to using non-hormonal birth control during the study.Your prolactin levels are higher than 30 ng/mL.I cannot take spironolactone due to severe adverse reactions.I have a serious heart or lung condition.Your thyroid-stimulating hormone (TSH) levels are not normal.Abnormal liver test resultsYour hemoglobin levels are consistently low, below a certain number based on your race.I am a girl aged 10-17, either after my first period or in mid to late puberty.You have very low levels of platelets or white blood cells in your blood.You have ongoing issues with your sodium or potassium levels being too high or too low.
Research Study Groups:
This trial has the following groups:- Group 1: Spironolactone
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- 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.
Androgen Syndrome Patient Testimony for trial: Trial Name: NCT04723862 — Phase < 1