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Spironolactone

Generic Name
Spironolactone
Brand Names
Aldactazide, Aldactone, Carospir, Qaialdo
Drug Type
Small Molecule
Chemical Formula
C24H32O4S
CAS Number
52-01-7
Unique Ingredient Identifier
27O7W4T232
Background

Spironolactone is a potassium-sparing diuretic. It binds to mineralocorticoid receptors and functions as aldosterone antagonists. It promotes sodium and water excretion and potassium retention. Spironolactone was originally developed purely for this ability before other pharmacodynamic properties of the drug were discovered. It is indicated to treat several conditions, including heart failure, edema, hyperaldosteronism, and hypertension. Off-label uses of spironolactone include hirsutism, female pattern hair loss, and adult acne vulgaris.

Spironolactone was developed in 1957, marketed in 1959, and approved by the FDA on January 21, 1960.

Indication

Spironolactone is indicated for the treatment of the following conditions:

As spironolactone has antiandrogenic activity, its off-label uses include the treatment of hirsutism, female pattern hair loss, and adult acne vulgaris.

Associated Conditions
Edema, Hypertension, Primary Aldosteronism, Primary Hyperaldosteronism, Secondary hyperaldosteronism, Chronic heart failure with reduced ejection fraction (NYHA Class III), Chronic heart failure with reduced ejection fraction (NYHA Class IV), Idiopathic hyperaldosteronism, Refractory Edema
Associated Therapies
Perioperative drug treatment, Maintenance therapy

Novel Treatment for Diastolic Heart Failure in Women

Phase 4
Completed
Conditions
Heart Failure
Interventions
First Posted Date
2005-09-21
Last Posted Date
2013-02-18
Lead Sponsor
Baylor College of Medicine
Target Recruit Count
48
Registration Number
NCT00206232
Locations
🇺🇸

Baylor College of Medicine Heart Clinic, Houston, Texas, United States

Efficacy of Therapy With the Spironolactone Pills Compared to Minoxidil Lotion in Female Pattern Hair Loss

Phase 2
Completed
Conditions
Female Pattern Hair Loss
First Posted Date
2005-09-15
Last Posted Date
2017-03-03
Lead Sponsor
University of British Columbia
Target Recruit Count
40
Registration Number
NCT00175617
Locations
🇨🇦

UBC Division of Dermatology, Hair Research and Treatment Centre, Vancouver, British Columbia, Canada

Renin-angiotensin-aldosterone System (RAAS), Inflammation, and Post-Operative Atrial Fibrillation (AF)

Phase 2
Completed
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2005-09-01
Last Posted Date
2013-03-22
Lead Sponsor
Vanderbilt University
Target Recruit Count
455
Registration Number
NCT00141778
Locations
🇺🇸

Vanderbilt University, Nashville, Tennessee, United States

Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy

Not Applicable
Terminated
Conditions
Heart Failure, Congestive
First Posted Date
2005-08-01
Last Posted Date
2009-07-15
Lead Sponsor
Hebei Medical University
Target Recruit Count
200
Registration Number
NCT00125437
Locations
🇨🇳

The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, China

PIE II: Pharmacological Intervention in the Elderly II

Phase 3
Completed
Conditions
Heart Failure, Congestive
Diastolic Heart Failure
Interventions
First Posted Date
2005-07-26
Last Posted Date
2019-02-27
Lead Sponsor
Wake Forest University
Target Recruit Count
80
Registration Number
NCT00123955
Locations
🇺🇸

Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States

Using the Drug Spironolactone to Test If It Reduces Protein Leakage From the Kidney

Phase 2
Completed
Conditions
Kidney Disease
Diabetic Nephropathy
Glomerulonephritis
Proteinuria
First Posted Date
2005-03-28
Last Posted Date
2005-06-24
Lead Sponsor
Melbourne Health
Target Recruit Count
60
Registration Number
NCT00106561
Locations
🇦🇺

Department of Nephrology, The Royal Melbourne Hospital, Melbourne, Victoria, Australia

Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function

Phase 3
Completed
Conditions
Heart Diseases
Heart Failure, Congestive
Cardiovascular Diseases
Interventions
First Posted Date
2004-10-15
Last Posted Date
2015-03-02
Lead Sponsor
Carelon Research
Target Recruit Count
3445
Registration Number
NCT00094302
Locations
🇺🇸

Drexel University College of Medicine, Philadelphia, Pennsylvania, United States

🇺🇸

University of Pennsylvania, Philadelphia, Pennsylvania, United States

🇺🇸

Cardiovascular Research Institute of Dallas, Dallas, Texas, United States

and more 266 locations

Treatment of Boys With Precocious Puberty

Phase 2
Completed
Conditions
Precocious Puberty
First Posted Date
1999-11-04
Last Posted Date
2008-03-04
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Target Recruit Count
80
Registration Number
NCT00001202
Locations
🇺🇸

National Institute of Child Health and Human Development (NICHD), Bethesda, Maryland, United States

Phase II Study of the Effect of Leuprolide Acetate and Spironolactone on Insulin Resistance in Hyperandrogenic Women With Polycystic Ovarian Disease or Hyperandrogenism Insulin Resistance Acanthosis Nigricans Syndrome

Phase 2
Completed
Conditions
Acanthosis Nigricans
Polycystic Ovary Syndrome
First Posted Date
1999-10-19
Last Posted Date
2005-06-24
Lead Sponsor
National Center for Research Resources (NCRR)
Registration Number
NCT00004311
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