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Last Updated: June 14, 2025

CLINICAL TRIALS PROFILE FOR SPIRONOLACTONE


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All Clinical Trials for Spironolactone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001202 ↗ Treatment of Boys With Precocious Puberty Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 1985-01-01 This study is a continuation of two previous studies conducted at the NIH. The first study , "Treatment of True Precocious Puberty with a Long-Acting Lutenizing Hormone Releasing Hormone Analog (D-Trp(6)-Pro(9)-Net-LHRH)" had less than optimal results. Some patients, all of whom were diagnosed with familial isosexual precocious puberty, had an inadequate response to the medication and were observed to have high levels of testosterone, advanced bone aging, and other complications of the disease. As a result these patients were enrolled in a second study In the second study, "Spironolactone Treatment for Boys with Familial Isosexual Precocious Puberty", - the patients received another medication, spironolactone (Aldactone). The drug blocked the effects of testosterone, -but bone age advancement did not improve. Some patients began experiencing gynecomastia (an abnormal growth of the male breasts). Researchers believe these may be the effects of elevated levels of estrodiol (a form of the female hormone, estrogen). In the present study, testolactone is added to the drug regimen to block the production of estrogen. The study therefore uses spironolactone to prevent the action of the male hormones (androgen) and testolactone to block the production of female hormones (estrogen). Deslorelin, an LHRH analog which works by turning off true (central) puberty, is added to the drug regimen once true puberty begins. This is because it is know that boys with familial male precocious puberty go into true puberty too early (despite treatment with spironolactone and testolactone), and when that happens, the spironolactone and testolactone are no longer as effective. The goal of the treatment is to delay sexual development until a more appropriate age and prevent short adult stature (height).
NCT00004311 ↗ 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 Completed Baylor College of Medicine Phase 2 1989-07-01 OBJECTIVES: I. Evaluate insulin resistance in thin and obese hyperandrogenic women with polycystic ovarian disease or hyperandrogenism insulin resistance acanthosis nigricans syndrome and in thin and obese controls, using an estimation of tissue sensitivity to insulin. II. Evaluate the effect of androgen suppression with leuprolide acetate and spironolactone on insulin secretion and resistance.
NCT00004311 ↗ 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 Completed National Center for Research Resources (NCRR) Phase 2 1989-07-01 OBJECTIVES: I. Evaluate insulin resistance in thin and obese hyperandrogenic women with polycystic ovarian disease or hyperandrogenism insulin resistance acanthosis nigricans syndrome and in thin and obese controls, using an estimation of tissue sensitivity to insulin. II. Evaluate the effect of androgen suppression with leuprolide acetate and spironolactone on insulin secretion and resistance.
NCT00007592 ↗ Hypertension Screening and Treatment Program Completed US Department of Veterans Affairs 1989-06-01 Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00007592 ↗ Hypertension Screening and Treatment Program Completed VA Office of Research and Development 1989-06-01 Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00046553 ↗ Brain Receptor Function in Post-Traumatic Stress Disorder Completed National Institute of Mental Health (NIMH) 2002-09-01 The purpose of this study is to examine the function of cortisol receptors in post-traumatic stress disorder (PTSD). Patients with PTSD have neurobiological dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis function. High corticotrophin releasing hormone (CRH) levels and decreased hippocampal volume are major features of the disorder. The mechanisms responsible for these alterations are not known. This study will evaluate the function of cortisol receptors to determine their roles in maintaining PTSD HPA axis dysregulation. Three groups of subjects will take part in the study: Patients with PTSD, healthy control subjects who were exposed to trauma in the past and remained healthy and healthy control subjects who were never traumatized At study entry, the cerebral spinal fluid (CSF) of all participants will be sampled and evaluated. Participants will also undergo a magnetic resonance imaging (MRI) scan of the brain as well as eye blink trace conditioning and neuropsychological tests. Participants will be admitted to the Clinical Center for two nights on three different occasions. At each overnight visits, blood levels of stress hormones will be measured every hour for 26 hours after medication or placebo are given. This will be the end of the study for both groups of healthy control subjects, with the exception that they may be asked to repeat neuropsychologic and eye blink tests after 12 weeks. Participants with PTSD will receive paroxetine for 10 weeks. After 10 weeks these participants will be reevaluated in exactly the same way as before treatment (except they will not repeat the MRI scan).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Spironolactone

Condition Name

Condition Name for Spironolactone
Intervention Trials
Hypertension 28
Heart Failure 24
Polycystic Ovary Syndrome 10
Diabetic Nephropathy 7
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Condition MeSH

Condition MeSH for Spironolactone
Intervention Trials
Heart Failure 52
Hypertension 44
Kidney Diseases 24
Renal Insufficiency, Chronic 18
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Clinical Trial Locations for Spironolactone

Trials by Country

Trials by Country for Spironolactone
Location Trials
United States 258
Canada 28
Germany 25
United Kingdom 22
Brazil 19
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Trials by US State

Trials by US State for Spironolactone
Location Trials
Texas 17
Massachusetts 14
California 14
New York 13
Pennsylvania 13
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Clinical Trial Progress for Spironolactone

Clinical Trial Phase

Clinical Trial Phase for Spironolactone
Clinical Trial Phase Trials
Phase 4 91
Phase 3 34
Phase 2/Phase 3 9
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Clinical Trial Status

Clinical Trial Status for Spironolactone
Clinical Trial Phase Trials
Completed 129
Recruiting 38
Unknown status 33
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Clinical Trial Sponsors for Spironolactone

Sponsor Name

Sponsor Name for Spironolactone
Sponsor Trials
National Heart, Lung, and Blood Institute (NHLBI) 14
Brigham and Women's Hospital 9
Vanderbilt University 8
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Sponsor Type

Sponsor Type for Spironolactone
Sponsor Trials
Other 395
Industry 41
NIH 33
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Spironolactone: Clinical Trials, Market Analysis, and Projections

Introduction to Spironolactone

Spironolactone, a potassium-sparing diuretic and mineralocorticoid receptor antagonist, has been a cornerstone in the treatment of various medical conditions, including hypertension, heart failure, and hyperaldosteronism. Its versatility extends to dermatological applications and hormonal treatments, making it a multifaceted therapeutic agent.

Clinical Trials Update

Kidney Transplant Patients

A recent clinical trial, the SPIREN trial, investigated the effects of spironolactone on kidney function in kidney transplant patients. The trial involved 188 patients randomized to either spironolactone or a placebo for a period of three years. The results showed that while spironolactone was safe for kidney transplant patients, it did not improve kidney function or reduce the progression of interstitial fibrosis. However, it did reduce 24-hour proteinuria after one year, although this effect did not translate into long-term benefits in kidney function[1].

Heart Failure and Hypertension

The CLEAR SYNERGY trial explored the potential of spironolactone in reducing the risk of new or worsening heart failure in patients recovering from a severe heart attack. This randomized, double-blind, placebo-controlled trial involved over 7,000 adults and found that spironolactone reduced the risk of heart failure by 31% compared to the placebo group. However, it did not significantly impact the rates of death, new heart attacks, or strokes. High potassium levels were a notable side effect, leading to more medication discontinuations in the spironolactone group[3].

Resistant Hypertension

The PATHWAY-2 trial highlighted spironolactone's efficacy in treating resistant hypertension. This study demonstrated that spironolactone was significantly more effective than other blood pressure-lowering drugs in patients with poor blood pressure control despite treatment with multiple medications. The trial established spironolactone as a first-choice treatment for resistant hypertension, attributing its success to its ability to address sodium retention[4].

Market Analysis

Market Size and Growth

The global spironolactone market is projected to grow significantly over the next few years, driven by several key factors. The increasing prevalence of cardiovascular diseases, such as hypertension and heart failure, is a major driver. Additionally, the expanding use of spironolactone in dermatology for conditions like acne and hirsutism, as well as its application in treating polycystic ovary syndrome (PCOS), is contributing to market growth[5].

Market Segmentation

The spironolactone market can be segmented based on application, end-users, dosage forms, and distribution channels. The primary applications include edema, hypertension management, heart failure, and dermatological treatments. End-users encompass hospitals, clinics, and home care settings. The market is also influenced by patient demographics and the availability of different dosage forms[5].

Market Drivers

  • Improvement in Healthcare Infrastructure: Emerging markets are seeing improved healthcare infrastructure, making spironolactone more accessible.
  • Expanded Use in Dermatology: The use of spironolactone in treating acne and hirsutism is driving market growth.
  • Preventive Healthcare Models: There is an increasing shift towards preventive healthcare, leading to more prescriptions for at-risk patients[5].

Market Restraints

  • Price Sensitivity: Generic competition and cost pressures impact the profitability of spironolactone pharmaceuticals.
  • Limited Awareness: Limited awareness among healthcare professionals about newer indications restricts widespread utilization.
  • Generic Competition: The availability of generic brands reduces market share and profitability for branded spironolactone drugs[5].

Market Projections

Forecast and Growth

The spironolactone market is forecasted to grow from 2025 to 2031, driven by the increasing demand for cardiovascular and dermatological treatments. The market size and revenue are expected to increase, with a notable compound annual growth rate (CAGR) during this period. The base year for calculations is 2023, with historical data from 2019 to 2023 and forecasted data from 2025 to 2031[2][5].

Opportunities and Challenges

  • Market Opportunities: Analyzing market expansion opportunities in congestive heart failure treatment, creating combination drugs, and exploring consumer education campaigns to boost awareness of spironolactone's diverse applications.
  • Market Challenges: Mitigating unforeseen environmental and economic impacts, addressing price sensitivity, and managing generic competition are key challenges. Strategic innovation, such as creating combination therapies and novel delivery systems, is crucial to enhance drug efficacy and patient experience[5].

Competitive Landscape

The competitive landscape of the spironolactone market is characterized by a mix of branded and generic products. Key industry players are focusing on market penetration, product development, and strategic investments. The market is highly competitive, with companies vying for market share through innovative products, partnerships, and robust marketing strategies[5].

Product Development and Innovation

The spironolactone market is witnessing significant product development and innovation. Upcoming technologies and research efforts are aimed at enhancing the therapeutic effects of spironolactone. Notable advancements include the development of combination therapies and novel delivery systems, which are expected to improve patient adherence and outcomes[5].

Consumer Behavior and Awareness

Consumer education campaigns are crucial in boosting awareness of spironolactone's diverse applications. Telemedicine and e-health solutions are also playing a significant role in reaching untapped demographics and enhancing patient adherence. Personalized medicine approaches are further intensifying these prospects by offering tailored treatment regimens enhanced by spironolactone[5].

Key Takeaways

  • Clinical Efficacy: Spironolactone has shown mixed results in clinical trials, with benefits in reducing heart failure risk but no significant impact on kidney function in transplant patients.
  • Market Growth: The global spironolactone market is projected to grow driven by increasing demand for cardiovascular and dermatological treatments.
  • Market Drivers: Improvement in healthcare infrastructure, expanded use in dermatology, and preventive healthcare models are key drivers.
  • Challenges: Price sensitivity, limited awareness, and generic competition are significant challenges.
  • Innovation: Strategic innovation in product development and delivery systems is essential for market growth.

FAQs

What are the primary uses of spironolactone?

Spironolactone is primarily used for treating hypertension, heart failure, hyperaldosteronism, and certain dermatological conditions like acne and hirsutism.

How effective is spironolactone in treating resistant hypertension?

Spironolactone is highly effective in treating resistant hypertension, as demonstrated by the PATHWAY-2 trial, which showed it to be more effective than other blood pressure-lowering drugs[4].

Does spironolactone improve kidney function in transplant patients?

No, the SPIREN trial found that spironolactone did not improve kidney function in kidney transplant patients over a three-year period[1].

What are the potential side effects of spironolactone?

Spironolactone can cause high potassium levels, which may lead to medication discontinuation. Other potential side effects include hyperkalemia and gynecomastia.

How is the spironolactone market expected to grow in the future?

The spironolactone market is expected to grow significantly from 2025 to 2031, driven by increasing demand for cardiovascular and dermatological treatments, and improvements in healthcare infrastructure[2][5].

Sources

  1. Effect of Spironolactone on Kidney Function in Kidney Transplant Patients. PubMed, 2024.
  2. Global Spironolactone Tablet Market Report 2024 Edition. Cognitive Market Research, 2021.
  3. Spironolactone, a Blood Pressure Medication, May Help Reduce Risk of New Heart Failure. American Heart Association, 2024.
  4. Spironolactone “A Clear Winner” for Resistant Hypertension. European Society of Cardiology, 2015.
  5. Spironolactone Drugs Market Size & Share 2025-2030. 360 Research Reports, 2024.
Last updated: 2024-12-31

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