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Last Updated: April 4, 2025

CLINICAL TRIALS PROFILE FOR MONISTAT 3


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All Clinical Trials for MONISTAT 3

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT01661556 ↗ Clinical Trial of Hydroquinone Versus Miconazol in Melasma Unknown status Hospital Central "Dr. Ignacio Morones Prieto" Phase 4 2011-10-01 Melasma is an acquired discoloration of the skin characterized by brown colour changes commonly on the face.The duration of this double-blind clinical trial will be 12 weeks. The control group will receive treatment with topical Hydroquinone (4%), and the other group topical miconazole. Miconazol has antimelanotic properties and can be used as treatment for melasma patients. The estimated number of subjects to be recruited and randomized for the study is at least 30. The purpose of this study is determine if there is a difference in the effectiveness of these two agents. Melasma Area and Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8, and 12. Photographs, colorimetry and histological assessment will be also evaluated. Occurrence of adverse effects will also be recorded.
NCT01661556 ↗ Clinical Trial of Hydroquinone Versus Miconazol in Melasma Unknown status Universidad Autonoma de San Luis Potosí Phase 4 2011-10-01 Melasma is an acquired discoloration of the skin characterized by brown colour changes commonly on the face.The duration of this double-blind clinical trial will be 12 weeks. The control group will receive treatment with topical Hydroquinone (4%), and the other group topical miconazole. Miconazol has antimelanotic properties and can be used as treatment for melasma patients. The estimated number of subjects to be recruited and randomized for the study is at least 30. The purpose of this study is determine if there is a difference in the effectiveness of these two agents. Melasma Area and Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8, and 12. Photographs, colorimetry and histological assessment will be also evaluated. Occurrence of adverse effects will also be recorded.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 2 of 2 entries

Clinical Trial Conditions for MONISTAT 3

Condition Name

10-0.100.10.20.30.40.50.60.70.80.911.1Melasma[disabled in preview]
Condition Name for MONISTAT 3
Intervention Trials
Melasma 1
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Condition MeSH

10-0.100.10.20.30.40.50.60.70.80.911.1Melanosis[disabled in preview]
Condition MeSH for MONISTAT 3
Intervention Trials
Melanosis 1
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Clinical Trial Locations for MONISTAT 3

Trials by Country

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Trials by Country for MONISTAT 3
Location Trials
Mexico 1
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Clinical Trial Progress for MONISTAT 3

Clinical Trial Phase

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 4[disabled in preview]
Clinical Trial Phase for MONISTAT 3
Clinical Trial Phase Trials
Phase 4 1
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Clinical Trial Status

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Unknown status[disabled in preview]
Clinical Trial Status for MONISTAT 3
Clinical Trial Phase Trials
Unknown status 1
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Clinical Trial Sponsors for MONISTAT 3

Sponsor Name

Sponsor Name for MONISTAT 3
Sponsor Trials
Hospital Central "Dr. Ignacio Morones Prieto" 1
Universidad Autonoma de San Luis Potosí 1
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Sponsor Type

100.0%0-0.200.20.40.60.811.21.41.61.822.2Other[disabled in preview]
Sponsor Type for MONISTAT 3
Sponsor Trials
Other 2
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MONISTAT 3: Clinical Trials, Market Analysis, and Projections

Introduction to MONISTAT 3

MONISTAT 3, containing the active ingredient miconazole nitrate, is a widely used antifungal medication, particularly for the treatment of vulvovaginal candidiasis (yeast infections). Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Clinical Studies Overview

Clinical studies involving MONISTAT 3 Vaginal Suppositories have been conducted to evaluate their efficacy and safety. In multi-center clinical trials, 440 women with vulvovaginal candidiasis were treated either with the MONISTAT 3 Vaginal Suppository for 3 days or the MONISTAT 7 Vaginal Cream for 7 days. The results showed that while the 3-day suppository had lower clinical cure rates compared to the 7-day cream, the differences were not statistically significant[1].

Safety and Adverse Effects

The clinical trials also reported on the safety profile of MONISTAT 3. Common adverse effects included vulvovaginal burning, itching, or irritation (2%), cramping (2%), and headaches (1.3%). Other complaints such as hives and skin rash occurred at an incidence of less than 0.5%. The therapy-related dropout rate was minimal at 0.3%[1].

Comparative Studies

A recent study compared the efficacy of miconazole with a probiotic, Limosilactobacillus fermentum (LF5), as an alternative treatment for yeast infections. The study found that LF5 was at least as clinically potent as miconazole, with fewer adverse local experiences (4% vs 12% for miconazole)[4].

Market Analysis

Global Yeast Infection Treatment Market

The global yeast infection treatment market, which includes MONISTAT 3, was valued at US$ 6,158.8 million in 2023 and recorded a historic CAGR of 3.9% from 2019 to 2023. This market is expected to continue growing, driven by increasing prevalence of yeast infections and advancements in treatment options[2].

Market Segmentation

The market is segmented by form, with creams/ointments, tablets/capsules, and others being key categories. MONISTAT 3, being a vaginal suppository, falls under the "others" category. The market is also segmented by distribution channels, including retail pharmacies, hospital pharmacies, specialty stores, online sales, and others[2].

Regional Analysis

The global market is analyzed by region, with North America, Europe, East Asia, South Asia, Oceania, and the Middle East and Africa being key regions. North America, particularly the United States and Canada, is a significant market for yeast infection treatments due to high healthcare spending and awareness of antifungal treatments[2].

Market Projections

Future Market Size

The global yeast infection treatment market is projected to grow from 2024 to 2034, with a focus on increasing demand for effective and convenient treatment options. The market size is expected to increase, driven by rising awareness and the introduction of new treatment forms and distribution channels[2].

Distribution Channel Trends

Online sales are expected to become a more prominent distribution channel, offering convenience and accessibility to patients. Retail pharmacies and hospital pharmacies will continue to be major distribution channels due to their established presence and trust among consumers[2].

Regional Growth

North America and Europe are anticipated to remain significant markets, while regions like East Asia and South Asia are expected to show rapid growth due to increasing healthcare expenditure and a growing middle class with higher disposable incomes[2].

Key Takeaways

  • Efficacy and Safety: MONISTAT 3 has shown efficacy in treating vulvovaginal candidiasis, although with some adverse effects.
  • Market Size: The global yeast infection treatment market is valued at US$ 6,158.8 million in 2023 and is expected to grow.
  • Market Segmentation: The market is segmented by form and distribution channels, with online sales becoming increasingly important.
  • Regional Analysis: North America and Europe are key markets, with Asia showing rapid growth potential.
  • Future Projections: The market is expected to grow, driven by increasing demand for effective treatments and expanding distribution channels.

FAQs

What is MONISTAT 3 used for?

MONISTAT 3 is used for the treatment of vulvovaginal candidiasis, commonly known as yeast infections.

What are the common adverse effects of MONISTAT 3?

Common adverse effects include vulvovaginal burning, itching, or irritation, cramping, and headaches.

How does MONISTAT 3 compare to other treatments?

MONISTAT 3 has been compared to a probiotic, Limosilactobacillus fermentum (LF5), and was found to have similar efficacy but more adverse local experiences.

What is the current market size of the yeast infection treatment market?

The global yeast infection treatment market was valued at US$ 6,158.8 million in 2023.

What are the key distribution channels for yeast infection treatments?

Key distribution channels include retail pharmacies, hospital pharmacies, specialty stores, online sales, and others.

Sources

  1. DailyMed: MONISTAT 3™ (miconazole nitrate, 200 mg) Vaginal Suppositories.
  2. Future Market Insights: Yeast Infection Treatment Market Revenue Forecast 2024-2034.
  3. Biospace: U.S. Clinical Trials Market Size Industry Analysis Report, 2033.
  4. Frontiers in Microbiology: Comparative analysis with topical miconazole in a single-blind study.
  5. Cognitive Market Research: Miconazole Market Report 2024 (Global Edition).

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