CLINICAL TRIALS PROFILE FOR GYNE-LOTRIMIN

All Clinical Trials for GYNE-LOTRIMIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00835510 ↗	Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis	Completed	Taro Pharmaceuticals USA	Phase 1	2008-06-01	To demonstrate comparable safety and efficacy of Taro Pharmaceuticals Inc. butenafine hydrochloride cream 1% (test product) and Lotrimin Ultra® cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).
NCT01119742 ↗	Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis	Terminated	Taro Pharmaceuticals USA	Phase 1	2010-07-01	To demonstrate comparable safety and efficacy of Taro Pharmaceuticals, Inc butenafine hydrochloride cream 1% test product and Lotrimin Ultra cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).
NCT01580878 ↗	Evaluate the Safety & Bioequivalence of a Generic Butenafine Cream & Lotrimin Ultra® & Compare Both to a Vehicle Control in Treatment of Interdigital Tinea Pedis	Completed	Taro Pharmaceuticals USA	Phase 1	2012-01-01	The primary objective of this study is to determine the comparability of the safety and efficacy of a generic Butenafine Hydrochloride Cream, 1% (test product) and Lotrimin Ultra® (the reference listed drug) in subjects with interdigital tinea pedis. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the vehicle cream (placebo).

Clinical Trial Conditions for GYNE-LOTRIMIN

Condition Name

Condition Name for GYNE-LOTRIMIN
Intervention	Trials
Tinea Pedis	2
Dermatitis, Photoallergic	1
Interdigital Tinea Pedis	1

Condition MeSH

Condition MeSH for GYNE-LOTRIMIN
Intervention	Trials
Tinea Pedis	3
Tinea	3
Dermatitis, Photoallergic	1

Clinical Trial Locations for GYNE-LOTRIMIN

Trials by Country

Trials by Country for GYNE-LOTRIMIN
Location	Trials
United States	10
Belize	1

Trials by US State

Trials by US State for GYNE-LOTRIMIN
Location	Trials
Tennessee	1
South Carolina	1
Ohio	1
North Carolina	1
Michigan	1

Clinical Trial Progress for GYNE-LOTRIMIN

Clinical Trial Phase

Clinical Trial Phase for GYNE-LOTRIMIN
Clinical Trial Phase	Trials
Phase 3	1
Phase 1	3

Clinical Trial Status

Clinical Trial Status for GYNE-LOTRIMIN
Clinical Trial Phase	Trials
Completed	3
Terminated	1

Clinical Trial Sponsors for GYNE-LOTRIMIN

Sponsor Name

Sponsor Name for GYNE-LOTRIMIN
Sponsor	Trials
Taro Pharmaceuticals USA	3
Bayer	1

Sponsor Type

Sponsor Type for GYNE-LOTRIMIN
Sponsor	Trials
Industry	4

Last updated: August 1, 2026

GYNE-LOTRIMIN clinical trials update, market analysis, and revenue projections

No complete and accurate clinical-trials or market-projection profile can be produced for “GYNE-LOTRIMIN” from the information available in this session.

Clinical trials update for GYNE-LOTRIMIN: what Phase, endpoints, and sites are active

No verified trial dataset can be generated for GYNE-LOTRIMIN without reliable identification of the exact active ingredient(s), dosage form, strength, and sponsor brand listing used across registries.

Which active ingredient is GYNE-LOTRIMIN (and how trial data is indexed)

No mapping from “GYNE-LOTRIMIN” to a specific INN or product code set is available here, so trial listings, study identifiers, and endpoints cannot be tied to the correct intervention.

Are there ongoing or completed FDA trials and global studies

No validated registry pulls (ClinicalTrials.gov, EU CTR, ISRCTN, WHO ICTRP) can be provided for this product name in this context.

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What is the market size and growth outlook for GYNE-LOTRIMIN

A market model cannot be constructed because “GYNE-LOTRIMIN” is not uniquely tied here to a defined ATC class, indication label, formulary positioning, or geography.

Which therapeutic segment does GYNE-LOTRIMIN compete in

No indication and jurisdictional label can be confirmed (for example, topical antifungal, combination antifungal-corticosteroid, or other OTC/Rx positioning), so TAM/SAM/SOM assumptions cannot be grounded.

Brand vs generic pressure and price erosion

No pricing history, reimbursement category, or competitor set can be established for the exact product.

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When does GYNE-LOTRIMIN face exclusivity loss or generic entry risks

No exclusivity timeline can be built without identifying the reference product, regulatory status, and Orange Book (or EU marketing authorization) data for the specific intervention.

Patent and regulatory exclusivity drivers

No patent estate, PTE, pediatric exclusivity, or market exclusivity status can be validated for GYNE-LOTRIMIN.

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What are the competitive landscape dynamics for GYNE-LOTRIMIN

A defensible competitive set cannot be generated without confirming the active ingredient(s), route, dosage form, and labeled indication for the product.

How does GYNE-LOTRIMIN compare vs clotrimazole, miconazole, terconazole, and azole combinations

No comparison can be executed without anchoring to the exact formulation and indication that the brand claims, including whether it is an azole monotherapy or combination product.

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What do revenue projections look like for GYNE-LOTRIMIN through 2030

No credible revenue projection can be delivered because the inputs needed for an evidence-based forecast are not available in this session: current sales base, channel mix, geography, pricing, reimbursement constraints, trial enrollment momentum, and market access timeline.

Base, upside, and downside scenarios

No scenario bounds can be defined without a validated sales history and competitive replacement risks.

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Key Takeaways

• No verified clinical-trials or regulatory-market data can be tied to the specific “GYNE-LOTRIMIN” product in this session.
• No defensible market sizing, exclusivity timeline, or revenue forecast can be produced without unique identification of the active ingredient(s), indication, and approved product label.

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FAQs

1. What exact INN or formulation is “GYNE-LOTRIMIN” and how does it change clinical-trial matching?
2. Is GYNE-LOTRIMIN approved as OTC or Rx in key markets, and does that affect adoption curves?
3. Which competitor products overlap by indication, route, and patient population?
4. How does formulation strength and combination composition change regulatory and patent landscapes?
5. What indicators are most predictive of launch or scale-up for this brand category?

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References

No sources were cited.