Last Updated: August 11, 2026

CLINICAL TRIALS PROFILE FOR MICONAZOLE 7 COMBINATION PACK


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for MICONAZOLE 7 COMBINATION PACK

Condition Name

Condition Name for MICONAZOLE 7 COMBINATION PACK
Intervention Trials
Oral Lichen Planus 3
Otomycosis 3
Bacterial Vaginosis 3
Healthy 2
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Condition MeSH

Condition MeSH for MICONAZOLE 7 COMBINATION PACK
Intervention Trials
Candidiasis 6
Lichen Planus, Oral 3
Lichen Planus 3
Vaginosis, Bacterial 3
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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
Egypt 3
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Trials by US State

Trials by US State for MICONAZOLE 7 COMBINATION PACK
Location Trials
Florida 5
California 4
Texas 3
Alabama 3
Missouri 2
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Clinical Trial Progress for MICONAZOLE 7 COMBINATION PACK

Clinical Trial Phase

Clinical Trial Phase for MICONAZOLE 7 COMBINATION PACK
Clinical Trial Phase Trials
PHASE3 1
PHASE2 1
Phase 4 9
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Clinical Trial Status

Clinical Trial Status for MICONAZOLE 7 COMBINATION PACK
Clinical Trial Phase Trials
Completed 21
Recruiting 3
Not yet recruiting 3
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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
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Sponsor Type

Sponsor Type for MICONAZOLE 7 COMBINATION PACK
Sponsor Trials
Other 29
Industry 15
NIH 3
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Last updated: July 28, 2026

Miconazole 7 Combination Pack clinical-trials and market outlook summary

No source-anchored, product-level clinical trial record, FDA status, Orange Book patent listing, or revenue data is available in the provided context to support a complete and accurate trials update and market projection for “Miconazole 7 Combination Pack” as a specific, regulated drug product.

Clinical trials update for Miconazole 7 Combination Pack: what studies are active or completed?

No product-identified clinical trial dataset is available to report study identifiers, enrollment status, endpoints, or completion dates for “Miconazole 7 Combination Pack.” Without a defined active ingredient pair, dose strength, route, and country-specific brand/formulation mapping, there is no reliable way to compile a clinical trials update at the pack level.

Which endpoints matter for intravaginal miconazole “combo” products?

A defensible trials update would normally be organized around:

  • Symptom resolution (itching, burning)
  • Mycologic cure (KOH microscopy and/or culture)
  • Recurrence or sustained cure windows (for example, 7 to 30 days post-treatment)
  • Safety metrics (local irritation, adverse events)

No such evidence can be extracted for this specific pack from the provided information.

Are there new phase 2 or phase 3 filings for miconazole combo packs?

No filing-level update is available.

What is the FDA or regulatory status of Miconazole 7 Combination Pack?

No FDA application pathway, approval date, labeling status, or product identifier (NDC/RLD) is available for “Miconazole 7 Combination Pack” in the provided context. Without that, an Orange Book-style status check, exclusivity mapping, or generic transition assessment cannot be completed for this specific product.

What is the Orange Book status of miconazole combination pack products?

A proper Orange Book answer requires:

  • Applicant/labeler and drug product match to Orange Book entries
  • Active ingredient mapping (single vs multiple actives)
  • Dosage form and strength match to patent listings

No such product-to-database mapping is available here.

Does this product have a switch to OTC or external manufacturing changes?

No regulatory change history is available.

Market analysis for Miconazole 7 Combination Pack: how big is the category and where does the pack fit?

A market projection needs at minimum:

  • Geographic scope (US, EU5, UK, GCC, etc.)
  • Channel (pharmacy vs OTC)
  • Pack composition (which actives besides miconazole, if any)
  • Dosage form and strength (cream, suppository, applicator count)
  • Competitor set and price bands

None of those inputs are present in the provided context, so a category and pack-level market sizing cannot be produced without generating unsupported claims.

Which competitors typically benchmark miconazole 1/3/7-day regimens?

A reliable competitor set depends on the actual pack content and market. Common comparators for intravaginal azoles include:

  • Single-dose and 3-day azole therapies (varies by country)
  • Other imidazoles in equivalent schedules

No product identification is available to correctly benchmark “Miconazole 7 Combination Pack.”

What pricing and payer dynamics drive demand for 7-day intravaginal azole packs?

A credible projection would link demand to:

  • OTC vs prescription mix
  • Insurance coverage changes
  • Seasonal recurrence patterns and adherence drivers
  • Manufacturer promotions and pack value

No data is available here.

When does exclusivity end for Miconazole 7 Combination Pack and what generic entry risks exist?

Exclusivity timelines require:

  • Orange Book listings (for US) or equivalent patent registers (EU SPC, UK, etc.)
  • Patent numbers, assignees, expiration dates, and exclusivity codes
  • Whether the product is protected by formulation, method-of-use, or combination patents

No patent register mapping exists in the provided context.

Are there Paragraph IV challenges for miconazole combo packs?

Paragraph IV analysis requires:

  • Listing the ANDA(s)
  • Carve-outs and certifications (I-IV)
  • Settlement or litigation docket outcomes

No such records are available here.

What formulation or method-of-use patents usually protect azole regimens?

Typical protection themes in azole products include:

  • Specific intravaginal formulation composition and excipients
  • Device/applicator features for dosing accuracy
  • Narrow method-of-use indications (less common for generic intravaginal azole products in many markets)

No mappable patent estate is provided for this specific pack.

How strong is the patent estate for intravaginal miconazole combination packs?

Patent strength requires a mapped set of:

  • Active ingredient/process/formulation patents
  • Remaining term by jurisdiction
  • Claim scope relevance to generic manufacturing and labeling
  • Litigation history

No mapped patent estate is available in the provided context.

Key jurisdictions for enforcement and launch timing

A defensible launch risk assessment requires at least:

  • US patent and Orange Book landscape
  • EU SPC and national patent coverage
  • UK and key supply-chain markets

No product coverage map is available here.

What patent litigation affects miconazole 7 combination pack products?

Litigation requires specific docket matches:

  • Parties and case numbers
  • Asserted patents and claim constructions
  • Settlements and timing commitments (if any)

No litigation records are available in the provided context.

Has there been any settlement affecting generic or biosimilar entry?

No settlement data is available.

What generic or OTC launch scenarios exist for Miconazole 7 Combination Pack?

Generic/OTC launch scenarios depend on:

  • Exclusivity and patent calendars
  • Regulatory pathway (ANDA vs OTC switch or line extension)
  • Product equivalence (bioequivalence and labeling)
  • Manufacturing/IP barriers

No regulatory and patent inputs are available for the specific pack.

How does Miconazole 7 Combination Pack compare with 1-day and 3-day intravaginal regimens?

A product-comparison requires confirmed pack composition and a trial or meta-analysis basis:

  • Symptom clearance and mycologic cure rates
  • Safety and tolerability
  • Adherence and patient preference outcomes

No pack definition or evidence base is provided here.

What outcomes typically differ between 7-day vs 1-day azole regimens?

Commonly evaluated differences in intravaginal azole schedules include:

  • Convenience and adherence
  • Local tolerability patterns
  • Cure rates by baseline severity and organism burden

No pack-specific data is available in the provided context.

Manufacturing and IP barriers for combination pack drugs

An IP barrier assessment requires:

  • The combination composition (miconazole plus what other ingredient, if any)
  • Formulation patents and process patents relevant to manufacturing
  • Device/applicator IP if part of the pack

No product-level formulation and device composition is available.

What manufacturing scale-up issues tend to delay generic packs?

For intravaginal products, typical bottlenecks can include:

  • Geometries and dosing accuracy for applicators
  • Consistency of semi-solid rheology
  • Stability and preservative compatibility

No specific barriers can be attributed to this pack.

Key Takeaways

  • A product-level clinical trials update cannot be generated for “Miconazole 7 Combination Pack” without a defined, source-anchored product identity (actives, strengths, dosage forms, and market).
  • A regulatory status and exclusivity/end-of-protection timeline cannot be produced without Orange Book (or equivalent) mapping for the specific pack.
  • Market sizing and forecast cannot be supported without country scope, pricing/channel inputs, competitor set, and product composition.

FAQs

  1. What clinical trials are registered for intravaginal miconazole 7-day combination products, and what are their current statuses?
  2. How can I identify the correct FDA listing (NDC/RLD) for “miconazole 7 combination pack” in order to check exclusivity and patents?
  3. What patent types (formulation, process, device, method-of-use) most often block generic entry for intravaginal azole regimens?
  4. How do 7-day and 1-day intravaginal azole regimens compare on mycologic cure and symptom resolution in randomized trials?
  5. What factors most affect launch timing for generic intravaginal antifungal packs after patent expiry?

References

No sources were provided in the prompt, so no inline citations or reference list can be generated.

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