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Spironolactone for Hyperandrogenism in Pubertal Girls (CBS010 Trial)
CBS010 Trial Summary
This trial is testing if a medication can normalize hormone levels in girls who are experiencing too much androgen.
CBS010 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCBS010 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 4 trial • 79 Patients • NCT02169089CBS010 Trial Design
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Who is running the clinical trial?
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- 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 generally healthy, though I may have obesity, PCOS, high androgen levels, or treated hypothyroidism.You have high levels of testosterone and show signs of excessive hair growth.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.
- Group 1: Spironolactone
- Group 2: Placebo
- 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.
- 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.
Frequently Asked Questions
Is this experiment engaging elderly participants?
"The eligibility criteria for this clinical trial stipulates that participants ought to be between the ages of 10 and 17."
What criteria must prospective participants meet to be eligible for this research?
"The trial is recruiting 32 adolescents aged 10 to 17 with hyperandrogenism. To receive consideration, applicants must be capable of abstaining from pregnancy via non-hormonal methods during the study period; they should also demonstrate mid-to late pubertal development (as indicated by Tanner breast stages 2-5), hyperandrogenism through serum free testosterone concentrations exceeding specific reference ranges and/or clinical hirsutism; finally, participants need to generally possess good health barring obesity, PCOS and hypothyroidism properly managed with medication."
What other scientific investigations have been conducted with respect to Spironolactone?
"Currently, 29 medical studies are exploring the benefits of Spironolactone with 7 trials in their final stage. While Boston Massachusetts is a hub for these experiments, there are 294 sites conducting clinical research into this medication."
Is participation in this research open to the public?
"Per clinicaltrials.gov, recruitment for this study is ongoing since its original posting on November 12th 2021 and modified as recently as July 28th 2022."
How many participants have been recruited to take part in this research endeavor?
"Affirmative. According to clinicaltrials.gov, recruitment for this medical trial is ongoing; it was initially posted on November 12th 2021 and most recently updated on July 28th 2022. Specifically, 32 volunteers need to be sourced from a single site."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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