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Spironolactone for Polycystic Ovary Syndrome
Study Summary
This trial will determine if spironolactone can reduce androgen production in obese girls with androgen excess.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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 • NCT02169089Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: spironolactone
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
How can I become a participant in this research?
"To meet the eligibility criteria for this trial, candidates must have a BMI that falls within the overweight range and be aged between 7 and 18. The research team is seeking 20 participants overall."
What is the aggregate number of individuals enrolled in this trial?
"Affirmative. Information displayed on clinicaltrials.gov demonstrates that this medical research is still accepting participants, which was initially publicised on December 9th 2016 and revised most recently on July 28th 2022. The study requires 20 test subjects from a single location to be enrolled for evaluation."
Does this medical trial take into account individuals who are past middle age?
"This trial is specifically for minors, aged 7 to 18 years. 246 trials are currently recruiting young people and 720 studies are actively enrolling senior citizens."
Are new participants being welcomed into this research endeavor?
"This clinical trial is presently open to participants, as indicated on the database at clinicaltrials.gov. It was originally listed in December 2016 and amended for accuracy last month (July 2022)."
To what extent has Spironolactone been examined in prior research?
"Currently, there are 7 studies for Spironolactone in their final phase with a total of 29 trials underway. While many clinical trial sites can be found within San Francisco, California and its environs, the drug is being tested at 294 locations throughout the nation."
What medical conditions is Spironolactone typically prescribed for?
"A physician might prescribe Spironolactone to treat primary hyperaldosteronism, cirrhosis of the liver, and certain medical interventions."
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