CLINICAL TRIALS PROFILE FOR MICONAZOLE 3 COMBINATION PACK

All Clinical Trials for Miconazole 3 Combination Pack

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 3 Combination Pack

Condition Name

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

Condition MeSH

Condition MeSH for Miconazole 3 Combination Pack
Intervention	Trials
Candidiasis	6
Otomycosis	3
Lichen Planus, Oral	3
Lichen Planus	3

Clinical Trial Locations for Miconazole 3 Combination Pack

Trials by Country

Trials by Country for Miconazole 3 Combination Pack
Location	Trials
United States	35
China	7
Brazil	5
Canada	4
Egypt	2

Trials by US State

Trials by US State for Miconazole 3 Combination Pack
Location	Trials
Florida	5
California	4
Alabama	3
Texas	3
Maryland	2

Clinical Trial Progress for Miconazole 3 Combination Pack

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Miconazole 3 Combination Pack

Sponsor Name

Sponsor Name for Miconazole 3 Combination Pack
Sponsor	Trials
Hill Dermaceuticals, Inc.	3
National Institute of Allergy and Infectious Diseases (NIAID)	2
University of Sao Paulo	2

Sponsor Type

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

Miconazole 3 Combination Pack: Clinical Trials, Market Analysis, and Projections

Introduction

The Miconazole 3 Combination Pack is a widely used over-the-counter (OTC) medication for treating vaginal yeast infections and relieving associated external itching and irritation. This article will delve into the clinical trials, market analysis, and future projections for this product.

Clinical Trials and Efficacy

Overview of Clinical Trials

While specific clinical trial data for the Miconazole 3 Combination Pack is not extensively detailed in the sources, it is known that miconazole nitrate, the active ingredient, has been thoroughly studied for its efficacy in treating vaginal yeast infections.

Efficacy in Treating Yeast Infections

Miconazole nitrate has been proven effective in numerous studies for its antifungal properties. The combination pack, which includes vaginal suppositories or inserts and an external cream, has been shown to cure most vaginal yeast infections and provide relief from external itching and irritation[2][4].

Safety and Tolerability

Clinical trials and post-marketing data indicate that miconazole nitrate is generally well-tolerated. Common side effects include mild vaginal burning, itching, or irritation, and abdominal cramping. Serious allergic reactions, though rare, can occur and require immediate medical attention[2][5].

Market Analysis

Market Demand

The demand for over-the-counter treatments for vaginal yeast infections remains high due to the prevalence of these infections among women. The convenience and effectiveness of the Miconazole 3 Combination Pack contribute to its popularity in the market.

Competitive Landscape

The market for vaginal yeast infection treatments is competitive, with several brands offering similar products. However, the Miconazole 3 Combination Pack, particularly under the Monistat brand, holds a significant market share due to its established reputation and efficacy[4].

Pricing and Availability

The product is widely available in pharmacies and online, making it easily accessible to consumers. Pricing varies slightly depending on the retailer and the specific formulation (suppositories, inserts, or prefilled cream applicators), but it generally remains affordable as an OTC option[2][4].

Market Projections

Growth Trends

The market for antifungal treatments is expected to grow due to increasing awareness about women's health and the rising incidence of fungal infections. The convenience and effectiveness of the Miconazole 3 Combination Pack position it well for continued market growth.

Consumer Preferences

Consumers are increasingly seeking quick and effective treatments for common health issues. The 3-day treatment regimen of the Miconazole 3 Combination Pack aligns well with consumer preferences for rapid relief and convenience[4].

Regulatory Environment

As an OTC product, the Miconazole 3 Combination Pack is subject to regulatory oversight. However, its long-standing presence in the market and compliance with regulatory standards ensure its continued availability without significant regulatory hurdles.

Key Features and Benefits

Formulations

The product is available in several formulations, including vaginal suppositories, inserts, and prefilled cream applicators, along with an external cream. This variety caters to different patient preferences and needs[2][4].

Dosage and Administration

The treatment involves inserting one suppository or insert into the vagina at bedtime for three consecutive nights, along with applying the external cream twice daily as needed for up to seven days. This straightforward regimen enhances patient compliance[2][4].

Side Effects and Precautions

While generally safe, it is important for patients to be aware of potential side effects and precautions, such as avoiding the use of contraceptive diaphragms, condoms, or tampons during treatment, and consulting a healthcare provider if symptoms persist or worsen[1][2].

Consumer Information and Counseling

Importance of Diagnosis

It is crucial for patients to have their symptoms diagnosed by a healthcare provider before using the Miconazole 3 Combination Pack, especially if it is their first time experiencing vaginal discharge, itching, or burning[2].

Proper Use

Patients should follow the enclosed consumer information leaflet for complete directions and information. This includes ensuring the product is not used if the packaging is damaged and storing the product at the recommended temperature[2].

Key Takeaways

• Efficacy: The Miconazole 3 Combination Pack is effective in treating vaginal yeast infections and relieving external itching and irritation.
• Market Demand: High demand due to the prevalence of vaginal yeast infections and the product's convenience and effectiveness.
• Competitive Landscape: Holds a significant market share despite competition from other brands.
• Growth Projections: Expected to grow due to increasing awareness about women's health and consumer preferences for quick and effective treatments.
• Regulatory Compliance: Compliant with regulatory standards, ensuring continued availability.

FAQs

Q: What is the Miconazole 3 Combination Pack used for?

A: The Miconazole 3 Combination Pack is used to treat vaginal yeast infections and relieve associated external itching and irritation.

Q: How do I use the Miconazole 3 Combination Pack?

A: Insert one suppository or insert into the vagina at bedtime for three consecutive nights, and apply the external cream twice daily as needed for up to seven days.

Q: Can I use the Miconazole 3 Combination Pack if I am pregnant or breastfeeding?

A: If pregnant or breastfeeding, it is recommended to consult a healthcare provider before using the product[1][2].

Q: What are the common side effects of the Miconazole 3 Combination Pack?

A: Common side effects include mild vaginal burning, itching, or irritation, and abdominal cramping. Serious allergic reactions can occur but are rare[2][5].

Q: Can I use the Miconazole 3 Combination Pack if I have never had a vaginal yeast infection before?

A: No, it is recommended to see a healthcare provider for diagnosis before using the product if it is your first time experiencing symptoms[2].

Sources

1. EMPR: MONISTAT 3 COMBINATION PACK Prescription & Dosage Information
2. Drugs.com: Topcare Miconazole 3: Package Insert / Prescribing Info
3. ClinicalTrials.gov: A FIRST-IN-HUMAN PHASE 1, DOSE
4. hcp.monistat.com: MONISTAT® 3-Day Treatment for Yeast Infections
5. WebMD: Miconazole vaginal - Uses, Side Effects, and More

Last updated: 2024-12-31