CLINICAL TRIALS PROFILE FOR MICONAZOLE 7 COMBINATION PACK

All Clinical Trials for Miconazole 7 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 7 Combination Pack

Condition Name

Condition Name for Miconazole 7 Combination Pack
Intervention	Trials
Bacterial Vaginosis	3
Oral Lichen Planus	3
Otomycosis	3
Healthy	2

Condition MeSH

Condition MeSH for Miconazole 7 Combination Pack
Intervention	Trials
Candidiasis	6
Candidiasis, Oral	3
Vaginal Diseases	3
Otomycosis	3

Clinical Trial Locations for Miconazole 7 Combination Pack

Trials by Country

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

Trials by US State

Trials by US State for Miconazole 7 Combination Pack
Location	Trials
Florida	5
California	4
Alabama	3
Texas	3
Maryland	2

Clinical Trial Progress for Miconazole 7 Combination Pack

Clinical Trial Phase

Clinical Trial Phase for Miconazole 7 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 7 Combination Pack
Clinical Trial Phase	Trials
Completed	21
Unknown status	3
Not yet recruiting	3

Clinical Trial Sponsors for Miconazole 7 Combination Pack

Sponsor Name

Sponsor Name for Miconazole 7 Combination Pack
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 7 Combination Pack
Sponsor	Trials
Other	27
Industry	15
NIH	3

Miconazole 7 Combination Pack: Clinical Trials, Market Analysis, and Projections

Introduction to Miconazole 7 Combination Pack

The Miconazole 7 Combination Pack, commonly known by the brand name MONISTAT® 7, is a widely used treatment for vaginal yeast infections. This product combines a 7-day intravaginal cream treatment with an external itch relief cream, making it a comprehensive solution for managing both internal and external symptoms of yeast infections.

Clinical Trials and Efficacy

Cure Rates and Treatment Durations

Clinical studies have consistently shown that miconazole nitrate, the active ingredient in MONISTAT® 7, is highly effective in treating vaginal yeast infections. A 7-day treatment regimen using the vaginal cream has been shown to have cure rates equivalent to longer treatment durations, such as 14-day regimens[4].

Comparison with Other Treatment Regimens

Studies comparing the 7-day miconazole cream regimen with 3-day regimens using 200-mg vaginal suppositories have found that the cure rates are similar, although the cream regimen may have a slightly higher efficacy[4].

Special Populations: Pregnancy and Diabetes

The CDC recommends a 7-day topical yeast infection treatment for pregnant women and individuals with diabetes. MONISTAT® 7 is specifically endorsed for these groups due to its low-dose, nightly application regimen, which is considered safe and effective[2][4].

Market Analysis

Market Demand and Trends

The market for antifungal treatments, particularly for vaginal yeast infections, is driven by the high prevalence of these infections among women. According to clinical data, vaginal yeast infections affect a significant portion of the female population at some point in their lives, creating a steady demand for effective treatments.

Competitive Landscape

MONISTAT® 7 competes in a market that includes other antifungal products such as fluconazole (oral antifungal) and various other topical and suppository treatments. However, its combination pack, which includes both intravaginal cream and external itch relief cream, sets it apart as a comprehensive solution.

Consumer Preferences

Consumers often prefer treatments that are easy to use, have minimal side effects, and provide quick relief from symptoms. MONISTAT® 7's low-dose, nightly application and the inclusion of external itch relief cream align well with these preferences.

Market Projections

Growth Potential

Given the ongoing demand for effective antifungal treatments and the specific recommendations for MONISTAT® 7 in certain patient groups (pregnant women and diabetics), the market for this product is expected to remain stable or see moderate growth. The convenience and efficacy of the 7-day treatment regimen are key factors driving this projection.

Market Share

MONISTAT® 7 is likely to maintain a significant market share in the antifungal treatment segment due to its established brand reputation, clinical efficacy, and the comprehensive nature of the combination pack.

Regulatory and Safety Considerations

FDA Approval and Recommendations

MONISTAT® 7 is an over-the-counter (OTC) product, and its formulation and dosing regimen have been approved and recommended by regulatory bodies. The product is designed to be safe for use by adults and children over 12 years old, with clear instructions provided for application and use[5].

Safety Profile

Clinical trials and post-marketing data have shown that miconazole nitrate is generally well-tolerated. The most common side effects are mild and include local irritation or itching, which are typically transient and manageable[4].

Consumer Information and Usage

Dosage and Administration

The product comes with clear instructions for use. Adults and children over 12 years old are advised to insert one applicatorful of the cream into the vagina at bedtime for 7 consecutive nights. The external itch relief cream can be applied twice daily as needed[5].

Storage and Handling

Users are advised to store the product at room temperature (20° - 25°C or 68° to 77°F) and to ensure the seal over the tube opening is intact before use[5].

Key Takeaways

• Efficacy: MONISTAT® 7 has high cure rates for vaginal yeast infections, comparable to longer treatment durations.
• Special Populations: Recommended for pregnant women and individuals with diabetes due to its safety and efficacy.
• Market Demand: Steady demand driven by the prevalence of vaginal yeast infections.
• Competitive Advantage: Comprehensive treatment including both intravaginal and external itch relief creams.
• Regulatory Compliance: Approved and recommended by regulatory bodies with a good safety profile.

FAQs

Q: What is the active ingredient in MONISTAT® 7?

A: The active ingredient in MONISTAT® 7 is miconazole nitrate.

Q: How long does the treatment last?

A: The treatment lasts for 7 consecutive nights, with one applicatorful of cream inserted into the vagina each night.

Q: Is MONISTAT® 7 safe for pregnant women?

A: Yes, MONISTAT® 7 is recommended for pregnant women due to its low-dose, nightly application regimen and proven safety[2][4].

Q: Can children use MONISTAT® 7?

A: Children over 12 years old can use MONISTAT® 7. For children under 12, it is recommended to consult a doctor before use[5].

Q: What are the common side effects of MONISTAT® 7?

A: Common side effects are mild and include local irritation or itching, which are typically transient and manageable[4].

Sources

1. MONISTAT® 7-Day Treatment for Yeast Infections - hcp.monistat.com
2. Monistat® 7-Day Yeast Infection Treatment Combination Pack (Cream) - monistat.com
3. 207103Orig1s000 - accessdata.fda.gov (Note: This source is not directly relevant to miconazole but was included in the search results)
4. Antifungal (miconazole) - MedCentral - medcentral.com
5. Monistat 7 Cream: Package Insert / Prescribing Information - drugs.com