CLINICAL TRIALS PROFILE FOR MICONAZOLE

All Clinical Trials for Miconazole

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004575 ↗	Effects of Miconazole on Blood Flow	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 1	2000-02-01	This study will investigate the effect of the drug miconazole on blood vessel dilation. Miconazole stops production of EDHF, a substance that causes arteries to dilate. EDHF is produced by the cells that line blood vessels. Normal volunteers between the ages of 21 to 60 may participate in this study. Candidates will be screened for eligibility with a medical history, physical examination, electrocardiogram and routine laboratory tests. Those enrolled will be injected with miconazole to study its effects on blood vessels. Study participants will take three aspirin tablets. After administration of a local anesthetic, small tubes will be inserted through a needle into the artery and vein of the forearm. These will be used to measure blood pressure and to draw blood samples during the study. Forearm blood flow will be measured using pressure cuffs placed on the wrist and upper arm, and a strain gauge (a rubber band device) placed around the forearm. When the cuffs are inflated, blood will flow into the arm, stretching the strain gauge, and the flow measurement will be recorded. Small doses of four drugs-bradykinin, sodium nitroprusside, miconazole, and LNMMA-will be given through the arterial catheter. Bradykinin stimulates the release of EDHF and can lower blood pressure. Sodium nitroprusside causes blood vessels to dilate and is used to treat high blood pressure and heart failure. Miconazole is commonly prescribed to treat various infections, including vaginal yeast infections, jock itch and athlete's foot. In much higher doses, it is used to treat fungal infections that have spread to the lungs, brain, kidneys, or bladder. LNMMA inhibits production of nitric oxide, another substance produced by the lining cells of blood vessels. Blood flow will be measured throughout the study, which will last approximately 3 hours.
NCT00128323 ↗	A Comparison of Gentian Violet (GV) Mouth Washes, Nystatin, and Ketoconazole Tabs in Treating Oropharyngeal Candidiasis	Completed	British Society for Antimicrobial Chemotherapy	Phase 3	2002-11-01	In resource constrained societies and where HIV is a problem, oral thrush causes significant morbidity. In adults, ketoconazole is used and sometimes oral nystatin. Both drugs are relatively expensive compared to GV solution and ketoconazole has significant side effects especially in association with some of the treatments for HIV related problems. In children, either GV solutions or nystatin are used, GV is a fraction of the cost of nystatin. GV at 1% solution discolours the mouth (blue) and in the older child and adult would mark them out as having HIV infections. A much more dilute solution of GV has proved equally effective in vitro and would not carry the same cosmetic problem. In this study of children, the investigators have compared the 3 solutions, 1% GV, 0.00165% GV and nystatin oral drops - all masked so that they look the same - to see if GV is more effective than nystatin, and to see if the weaker solution of GV is as effective as the stronger solution.
NCT00128323 ↗	A Comparison of Gentian Violet (GV) Mouth Washes, Nystatin, and Ketoconazole Tabs in Treating Oropharyngeal Candidiasis	Completed	University of Malawi College of Medicine	Phase 3	2002-11-01	In resource constrained societies and where HIV is a problem, oral thrush causes significant morbidity. In adults, ketoconazole is used and sometimes oral nystatin. Both drugs are relatively expensive compared to GV solution and ketoconazole has significant side effects especially in association with some of the treatments for HIV related problems. In children, either GV solutions or nystatin are used, GV is a fraction of the cost of nystatin. GV at 1% solution discolours the mouth (blue) and in the older child and adult would mark them out as having HIV infections. A much more dilute solution of GV has proved equally effective in vitro and would not carry the same cosmetic problem. In this study of children, the investigators have compared the 3 solutions, 1% GV, 0.00165% GV and nystatin oral drops - all masked so that they look the same - to see if GV is more effective than nystatin, and to see if the weaker solution of GV is as effective as the stronger solution.
NCT00390780 ↗	Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients	Completed	Onxeo	Phase 3	2006-07-01	The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg (1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14 days of treatment (at the test of cure visit, at Day 17-19).
NCT00498680 ↗	Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i	Unknown status	Rambam Health Care Campus	Phase 4	2007-03-01	A prospective, randomized, 3-arm parallel trial on 45 males with ED that were never exposed to PDE5i therapy (naïve patients) will be enrolled.In each group, every patient will receive three treatment regimes (Viagra®50mg & Levitra®10mg, Viagra®100mg, Levitra®20mg), in different sequences of administration in such a manner that eventually each patient will receive all regimes in a double- blinded fasion.Safety will be evaluated at pre- screening by measuring hourly vital signs (blood pressure, heart rate)for 4 consecutive hours after taking half-dose combination. Any decrease in blood pressure of 20 mmhg below baseline will exclude the subject from the study. Effcacy will be evaluated by questionnaires (IIEF, Quality of erection questionnaire, grade of erection scale, Sear, QVS and Sexual Encounter Profiles for each sexual event). Non-parametric statistical analysis of the collected data Comparing the 3 groups will be performed.
NCT00668538 ↗	Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans	Completed	Odense University Hospital	N/A	2008-04-01	The purpose of this study, is to study the uptake of the pharmaceutical antifungal miconazole when used as a vaginal suppository in young women. The investigators want to know if the uptake is big enough to cause a biological effect (effect on CYP1A2 and CYP3A4 activity).

Clinical Trial Conditions for Miconazole

Condition Name

Condition Name for Miconazole
Intervention	Trials
Bacterial Vaginosis	3
Oral Lichen Planus	3
Otomycosis	3
Healthy	2

Condition MeSH

Condition MeSH for Miconazole
Intervention	Trials
Candidiasis	6
Lichen Planus	3
Vaginosis, Bacterial	3
Candidiasis, Oral	3

Clinical Trial Locations for Miconazole

Trials by Country

Trials by Country for Miconazole
Location	Trials
United States	35
China	7
Brazil	5
Canada	4
Kenya	2

Trials by US State

Trials by US State for Miconazole
Location	Trials
Florida	5
California	4
Texas	3
Alabama	3
North Carolina	2

Clinical Trial Progress for Miconazole

Clinical Trial Phase

Clinical Trial Phase for Miconazole
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	8
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Miconazole
Clinical Trial Phase	Trials
Completed	21
Unknown status	3
Not yet recruiting	3

Clinical Trial Sponsors for Miconazole

Sponsor Name

Sponsor Name for Miconazole
Sponsor	Trials
Hill Dermaceuticals, Inc.	3
Embil Pharmaceutical Co. Ltd	2
National Institute of Allergy and Infectious Diseases (NIAID)	2

Sponsor Type

Sponsor Type for Miconazole
Sponsor	Trials
Other	27
Industry	15
NIH	3

Miconazole: Clinical Trials, Market Analysis, and Projections

Introduction

Miconazole is a widely used antifungal drug effective against various types of fungal and yeast infections. This article provides an update on recent clinical trials, market analysis, and projections for miconazole, highlighting its efficacy, safety, and market trends.

Clinical Trials Update

Efficacy and Safety in Vaginal Candidiasis

A recent comparative analysis between miconazole and a probiotic strain (LF5) in treating vaginal candidiasis showed that both treatments achieved high rates of microbiological eradication of Candida spp. within a three-day treatment period. However, LF5 demonstrated a lower incidence of local adverse reactions, with only 4% of participants experiencing mild to moderate symptoms, compared to 12% with miconazole[1].

Oropharyngeal Candidiasis

A phase III, double-blind trial compared the efficacy and safety of miconazole buccal tablets (MBT) with itraconazole capsules in treating oropharyngeal candidiasis. The results indicated that MBT was non-inferior to itraconazole, with higher mycological cure rates and similar tolerability. The clinical cure rates were 68% for MBT and 59% for itraconazole, with mycological cure rates of 68.2% and 42.0%, respectively[3].

Otomycosis Treatment

An ongoing phase III clinical trial is evaluating the efficacy and safety of 2% miconazole oil for the treatment of otomycosis. This randomized, double-blind study compares miconazole oil with a placebo (mineral oil) over a 14-day treatment period. The primary endpoint is the clinical cure rate at the end of the treatment period[4].

Market Analysis

Global Market Size and Growth

The global miconazole market has been growing steadily, driven by increasing demand for antifungal treatments. As of 2023, the market size was significant, with a projected compound annual growth rate (CAGR) from 2024 to 2031. The market is segmented by type, application, and region, providing insights into the most lucrative segments and future growth opportunities[2][5].

Regional Market Insights

The miconazole market is analyzed across major regions, including the United States, Europe, China, Japan, Southeast Asia, India, and Brazil. Each region's market size, revenue, and growth rate are forecasted from 2019 to 2031, helping businesses understand regional dynamics and plan their strategies accordingly[5].

Application Segments

Miconazole is used in various applications, including vaginal treatments, external skin treatments, and oral treatments. The market analysis reveals that these segments are expected to grow at different rates, with vaginal treatments being one of the most significant segments due to the high prevalence of vaginal candidiasis[5].

Competitive Landscape

The market is competitive, with several major players involved in the production and distribution of miconazole. The report provides detailed profiles of these companies, including their product analysis, sales, price, revenue, and gross margin. This information helps in understanding the competitive landscape and identifying potential market opportunities[5].

Market Projections

Forecasted Growth

The global miconazole market is expected to grow significantly from 2025 to 2031, driven by increasing demand for antifungal treatments and the expanding healthcare sector. The forecast includes consumption volume, revenue, and price trends, providing a comprehensive outlook for the market[5].

Regional Growth

Regional growth rates are forecasted, with some regions expected to exhibit higher growth rates due to factors such as population growth, increasing healthcare expenditure, and rising awareness of fungal infections. For instance, the Asia-Pacific region is anticipated to be a key growth area due to its large population and growing healthcare needs[5].

Market Dynamics

The market is influenced by various factors, including mergers and acquisitions, technological advancements, and changes in consumer preferences. The report provides a SWOT analysis, PESTEL analysis, and Porter's Five Forces analysis to help businesses understand the market dynamics and develop strategic plans[5].

Key Takeaways

• Clinical Efficacy: Miconazole has been shown to be effective in treating various fungal infections, including vaginal candidiasis and oropharyngeal candidiasis, with comparable or superior outcomes to other antifungal agents.
• Safety Profile: Miconazole generally has a good safety profile, although it may cause local adverse reactions, which are typically mild to moderate.
• Market Growth: The global miconazole market is projected to grow significantly from 2025 to 2031, driven by increasing demand and expanding healthcare needs.
• Regional Insights: Different regions have varying growth rates and market dynamics, with the Asia-Pacific region expected to be a key growth area.
• Competitive Landscape: The market is competitive, with several major players, and understanding their strategies and market positions is crucial for business planning.

FAQs

What are the common applications of miconazole?

Miconazole is commonly used for vaginal treatments, external skin treatments, and oral treatments to combat fungal and yeast infections[5].

How does miconazole compare to other antifungal agents in clinical trials?

Miconazole has been shown to be non-inferior or superior to other antifungal agents like itraconazole and LF5 in various clinical trials, with higher mycological cure rates and a favorable safety profile[1][3].

What is the projected growth rate of the global miconazole market?

The global miconazole market is expected to grow at a significant compound annual growth rate (CAGR) from 2024 to 2031, driven by increasing demand and healthcare needs[2][5].

Which regions are expected to drive the growth of the miconazole market?

The Asia-Pacific region, along with other emerging markets, is anticipated to be a key growth area due to its large population and growing healthcare needs[5].

What are the potential side effects of miconazole?

Miconazole can cause local adverse reactions, which are typically mild to moderate, such as local intolerance and mild symptoms like itching or burning[1][3].

Sources

1. Frontiers in Microbiology: "Comparative Analysis of LF5 and Miconazole in Treating Vaginal Candidiasis"[1].
2. Cognitive Market Research: "Miconazole Market Report 2024 (Global Edition)"[2].
3. PubMed: "A Randomized, Multi-Centered, Double-Blind, Phase 3 Trial of Miconazole Buccal Tablets and Itraconazole Capsules in Treating Oropharyngeal Candidiasis"[3].
4. CenterWatch: "Phase III Efficacy and Safety Study of Miconazole Oil for Otomycosis"[4].
5. Maia Research: "Global Miconazole Nitrate Consumption Market Research Report 2013-2025"[5].