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Spironolactone for Excess Androgen Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Excess Androgen Syndrome+2 MoreSpironolactone - Drug
Eligibility
7 - 18
Female
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Study Summary

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

Eligible Conditions
  • Excess Androgen Syndrome
  • Obesity
  • Polycystic Ovary Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 12 weeks after spironolactone treatment

Week 12
Glucose tolerance test
Week 12
Changes in free testosterone and 17-hydroxyprogesterone levels after ACTH and rhCG administration respectively, before and after spironolactone administration for 12 weeks

Trial Safety

Safety Progress

1 of 3

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Side Effects for

Spironolactone
15%HEART FAILURE
13%HYPERKALEMIA
8%CHEST PAIN
8%KIDNEY DISEASE
7%HYPERTENSION
5%DIARRHEA
5%HEADACHE
5%UPPER RESPIRATORY INFECTION
4%HYPOTENSION
4%MYOCARDIAL INFARCTION
4%ATRIAL FIBRILLATION
4%PNEUMONIA
4%DEATH
4%STROKE
4%BACK PAIN
4%BRONCHITIS
4%DIZZINESS
4%INFLUENZA
3%URINARY TRACT INFECTION
3%COUGH
3%ELEVATED CREATININE
3%GASTRITIS
3%GYNECOMASTIA
3%NAUSEA
3%WEAKNESS
2%DYSPNEA
2%FRACTURE
2%ANEMIA
2%GOUT
2%ABDOMINAL PAIN
2%CONSTIPATION
2%DIABETES
2%INSOMNIA
2%LEG PAIN
2%LOWER EXTREMITY EDEMA
2%OSTEOARTHRITIS
2%SHORTNESS OF BREATH
2%SYNCOPE
1%ARRHYTHMIA
1%ALTERED MENTAL STATUS
1%EPISTAXIS
1%HYPONATREMIA
1%VERTIGO
1%HYPERGLYCEMIA
1%ARM INJURY
1%TACHYCARDIA
1%KNEE PAIN
1%ACUTE CORONARY SYNDROME
1%CELLULITIS
1%BRADYCARDIA
1%ARTHRITIS
1%ASTHMA
1%BREAST PAIN
1%VOMITING
1%ELEVATED CARDIAC ENZYMES
1%VENOUS INSUFFICIENCY
1%PARASTHESIA
1%CARDIAC ARREST
1%CHRONIC OBSTRUCTIVE PULMONARY DISEASE
1%CORONARY ARTERY DISEASE
1%GI BLEED
1%LUNG CANCER
1%MEDICAL EXAM
1%PLEURAL EFFUSION
1%PULMONARY EDEMA
1%RESPIRATORY FAILURE
1%SEPSIS
1%POLYPS
1%ACUTE RESPIRATORY DISEASE
1%ALLERGY
1%BODY PAIN
1%CATARACTS
1%BRUISE
1%CYST
1%DECREASED APPETITE
1%DEPRESSION
1%DEHYDRATION
1%DERMATITIS
1%DYSLIPIDEMIA
1%PRURITIS
1%FALL
1%HEMATURIA
1%HIP PAIN
1%HYPOGLYCEMIA
1%HYPOKALEMIA
1%HYPOTHYROIDISM
1%PYELONEPHRITIS
1%OSTEOCHONDROSIS
1%RHINITIS
1%SHINGLES
1%SINUSITIS
1%SKIN CANCER
1%SHOULDER PAIN
1%URINARY RETENTION
1%WEIGHT GAIN
1%PALPITATIONS
1%SLEEP APNEA
This histogram enumerates side effects from a completed 2013 Phase 3 trial (NCT00094302) in the Spironolactone ARM group. Side effects include: HEART FAILURE with 15%, HYPERKALEMIA with 13%, CHEST PAIN with 8%, KIDNEY DISEASE with 8%, HYPERTENSION with 7%.

Trial Design

1 Treatment Group

spironolactone
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Spironolactone · No Placebo Group · N/A

spironolactone
Drug
Experimental Group · 1 Intervention: Spironolactone · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spironolactone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks after spironolactone treatment

Who is running the clinical trial?

University of VirginiaLead Sponsor
687 Previous Clinical Trials
1,464,250 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

Eligibility Criteria

Age 7 - 18 · Female Participants · 4 Total Inclusion Criteria

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