CLINICAL TRIALS PROFILE FOR LEVITRA

All Clinical Trials for LEVITRA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00377793 ↗	Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II	Completed	Bayer	Phase 4	2006-07-01	This trial is to provide additional important information on the impact of the treatment of the man its ED with vardenafil on partnership. This study is being run at up to 50 study centers in Europe and South Africa to evaluate the use of vardenafil in adult men with erectile dysfunction (often called impotence), and their female partner's sexual quality of life. Many men experience occasional erectile problems during their lives. However, when this becomes a continued problem, it can affect both the man and his female partner. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to 1) study the effectiveness and safety of vardenafil, and 2) show whether treating a man its erectile dysfunction with vardenafil will improve his female partner its sexual quality of life. The second part (week 12) of the study (Educational program) a subgroup of subjects/couples, approximately 50% of the randomized subjects, will receive an educational program concerning ED in the from of a DVD.
NCT00379756 ↗	A Study Evaluating Vardenafil Compared to Placebo in Subjects With Erectile Dysfunction (ED) and Dyslipidemia	Completed	GlaxoSmithKline	Phase 4	2006-05-22	This is a study consisting of four periods (screening, run-in, treatment, follow-up). A four-week treatment-free, run-in period where the subject will make at least four attempts at intercourse on four separate days with at least 50% of the attempts must be unsuccessful. During run-in the subjects will be using a stopwatch to measure the time from erection perceived hard enough for penetration until withdrawal from the partner's vagina. Next there are 12 weeks of treatment with either placebo or LEVITRA. Each subject will be required to visit the clinic on 5 occasions over a period of 4 months.
NCT00443625 ↗	Phase 1 Study of SK3530 to Investigate of the Effect of Food	Completed	SK Chemicals Co., Ltd.	Phase 1	2006-12-01	This study was designed to investigate the food effect of SK3530 on the pharmacokinetics (PKs).
NCT00443625 ↗	Phase 1 Study of SK3530 to Investigate of the Effect of Food	Completed	SK Chemicals Co.,Ltd.	Phase 1	2006-12-01	This study was designed to investigate the food effect of SK3530 on the pharmacokinetics (PKs).
NCT00461565 ↗	FDA Phase IV - Commitment - Retinal Function Study	Completed	GlaxoSmithKline	Phase 4	2005-02-01	Vardenafil (Levitra) and Sildenafil (Viagra) are drugs that are marketed for use in patients with erectile dysfunction. The purpose of this study is to find out if there are any changes in the eye after taking at least 15 doses of Vardenafil and after two doses of Sildenafil. This is a double-blind study, which means that neither you nor the study doctor will know which treatment you are receiving. If you qualify for the study, you will receive:- Vardenafil 20 mg twice per week (Monday and Thursday) for a maximum of 8 weeks. There will be two times when this occurs during the study.- Sildenafil 200 mg/day for two days. There will be two times when this occurs during the study. - Placebo (a pill that looks like vardenafil or sildenafil but has no active ingredient).
NCT00461565 ↗	FDA Phase IV - Commitment - Retinal Function Study	Completed	Bayer	Phase 4	2005-02-01	Vardenafil (Levitra) and Sildenafil (Viagra) are drugs that are marketed for use in patients with erectile dysfunction. The purpose of this study is to find out if there are any changes in the eye after taking at least 15 doses of Vardenafil and after two doses of Sildenafil. This is a double-blind study, which means that neither you nor the study doctor will know which treatment you are receiving. If you qualify for the study, you will receive:- Vardenafil 20 mg twice per week (Monday and Thursday) for a maximum of 8 weeks. There will be two times when this occurs during the study.- Sildenafil 200 mg/day for two days. There will be two times when this occurs during the study. - Placebo (a pill that looks like vardenafil or sildenafil but has no active ingredient).
NCT00470873 ↗	Vardenafil Treatment Of Erectile Dysfunction In Depressive And Non-Depressive Men	Completed	Bayer		2007-01-01	The primary aim of this open, uncontrolled, prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction. The secondary aim of this study is to assess the influence of the treatment with Levitra on self-esteem (depressive symptomology) in men with ED.

Clinical Trial Conditions for LEVITRA

Condition Name

Condition Name for LEVITRA
Intervention	Trials
Erectile Dysfunction	17
Impotence	2
Pulmonary Arterial Hypertension	2
Endothelial Dysfunction	2

Condition MeSH

Condition MeSH for LEVITRA
Intervention	Trials
Erectile Dysfunction	20
Hypertension	4
Familial Primary Pulmonary Hypertension	3
Pulmonary Arterial Hypertension	3

Clinical Trial Locations for LEVITRA

Trials by Country

Trials by Country for LEVITRA
Location	Trials
United States	30
Germany	12
Spain	8
China	7
United Kingdom	4

Trials by US State

Trials by US State for LEVITRA
Location	Trials
Connecticut	2
New York	2
Nevada	1
Nebraska	1
Missouri	1

Clinical Trial Progress for LEVITRA

Clinical Trial Phase

Clinical Trial Phase for LEVITRA
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for LEVITRA
Clinical Trial Phase	Trials
Completed	18
Unknown status	7
Terminated	1

Clinical Trial Sponsors for LEVITRA

Sponsor Name

Sponsor Name for LEVITRA
Sponsor	Trials
Bayer	12
GlaxoSmithKline	4
Rabin Medical Center	2

Sponsor Type

Sponsor Type for LEVITRA
Sponsor	Trials
Industry	22
Other	11

LEVITRA (vardenafil) Clinical Trials Update, Market Analysis, and Projection

Last updated: May 2, 2026

What is LEVITRA and what is its current clinical positioning?

LEVITRA is the brand name for vardenafil, a phosphodiesterase-5 (PDE5) inhibitor used for:

• Erectile dysfunction (ED) in men
• Benign prostatic hyperplasia-related lower urinary tract symptoms (BPH/LUTS) is a distinct therapeutic area where vardenafil has been studied, but it is not the core, label-defining indication in the US EU market compared with ED (market impact is driven by ED use).

Regulatory status context (product category):

• Vardenafil is a mature, off-patent small molecule. Market access in most geographies is dominated by generic erosion rather than incremental clinical innovation.
• Clinical development activity tends to shift toward label expansions, combination regimens, and formulation work, rather than first-in-class endpoints.

Evidence mix in the clinical record Across the vardenafil clinical program base, the recurring efficacy benchmark is improvement in erectile function and sexual satisfaction endpoints aligned to ED trial standards (e.g., IIEF-EF domain metrics in historical pivotal studies). In mature PDE5 inhibitor classes, later trials often focus on:

• Onset of action and dosing regimens
• Tolerability profiles across comorbid populations
• Comparative effectiveness versus sildenafil/tadalafil in head-to-head or indirect comparisons
• Real-world adherence and persistence proxies

No new, label-driving late-stage program is indicated by the data ecosystem at the brand level for LEVITRA specifically, given the drug’s age and generic penetration.

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What do recent clinical trials data flows imply for LEVITRA?

Because vardenafil is off-patent, the clinical trials landscape is typically fragmented and sponsor-driven by generics, investigator-led studies, or formulation research. The practical implication for a market decision is straightforward: trial activity rarely translates into meaningful brand differentiation. Most trial-level developments do not reverse generic price pressure.

High-level clinical update pattern for mature PDE5 inhibitors For a drug like vardenafil, recent activity usually clusters into:

• Formulation and bioequivalence (BE) studies for generic entrants
• Pharmacokinetic/pharmacodynamic (PK/PD) studies around dosing, food effects, and patient subgroups
• Comparative regimen studies across PDE5 inhibitors rather than novel mechanisms

Business takeaway: clinical activity around vardenafil mostly supports access and safe use, not a new competitive pivot that would materially lift branded LEVITRA demand.

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What is the market structure for vardenafil/LEVITRA?

LEVITRA’s market is driven by PDE5-inhibitor ED demand, but competition is dominated by:

• Generic sildenafil
• Generic tadalafil
• Generic vardenafil
• In some markets, brand-level residuals from competitors (e.g., sildenafil/tadalafil branded versions in certain channels, though most are also off-patent)

Competitive positioning (economic reality)

Because vardenafil is generic in most markets, the brand’s commercial performance is influenced by:

• Wholesale/retail channel contracts
• Pricing resets
• Substitution strength at pharmacy counter level
• Local reimbursement and formulary placement
• Perceived patient tolerability and dosing convenience relative to sildenafil and tadalafil

Channel dynamics that matter

For ED drugs, substitution is high because:

• Multiple PDE5 inhibitors are therapeutically substitutable
• Patients and prescribers are familiar with the class
• Pharmacy stocking incentives favor lowest effective price

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What does the ED PDE5 inhibitor market imply for vardenafil demand?

The PDE5 inhibitor market is mature, with long-run demand tied to:

• Male aging demographics
• Cardiovascular comorbidity prevalence
• Uptake of chronic ED management
• Access economics (generic availability and price)

Vardenafil’s share is constrained by:

• Tadalafil’s once-daily convenience in some segments
• Sildenafil’s entrenched availability and physician familiarity
• Price competition that pushes vardenafil toward parity with other generics

Operational market projection logic for LEVITRA A brand like LEVITRA generally tracks one of two trajectories:

• Low-growth decline due to generic substitution, or
• Stable-to-slow decline if the brand maintains channel presence in specific geographies or private-label dynamics

Given mature off-patent status, the base case for LEVITRA is typically volume drift toward generics rather than net brand expansion.

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Market analysis: where does LEVITRA likely hold value?

Even with generic erosion, brands can retain localized value through:

• Tender or pharmacy formulary retention in specific countries
• Brand loyalty in certain physician cohorts
• Patient preference where dosing experience differs
• Supply reliability during generic shortages

However, absent patent-backed differentiation, value retention tends to be structural, not clinical.

Where competitive pressure is highest

• High-income markets with dense generic penetration
• Markets with strong pharmacy substitution policies
• Systems with price-linked reimbursement

Where competitive pressure is lower

• Markets with slower generic substitution cycles
• Markets with procurement practices that sustain historical brand contracts
• Segments where prescribers avoid switching once effective therapy is established

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How should investors project LEVITRA revenue and volume?

Given the drug’s off-patent status, projection should be framed around market contraction-free dynamics (ED prevalence growth) offset by share dilution (generic substitution). The projection method for a mature branded PDE5 inhibitor usually uses:

Revenue = Units sold x Net price
Where:

• Units trend with ED demand plus substitution drag
• Net price trends toward the generic reference price

Projection structure (scenario framework)

Use three scenarios built from typical market mechanics:

Scenario	Unit trend vs prior year	Net price trend vs prior year	Outcome
Base case	Low single-digit decline or flat	Low-to-mid single-digit decline	Gradual revenue erosion
Bear case	Mid single-digit decline	Mid-to-high single-digit decline	Accelerated revenue contraction
Bull case	Flat units	Low price decline or temporary stabilization	Slower decline, potential plateau

For a brand like LEVITRA, base case typically dominates: generic substitution pressure persists, but ED demand and physician familiarity prevent sharp collapse.

What drives year-to-year volatility

• Tender pricing
• Generic supply interruptions
• Local policy changes affecting pharmacy substitution or reimbursement
• Competitor product promotions and stocking cycles

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Are there patent or exclusivity events that could change LEVITRA prospects?

LEVITRA/vardenafil has been commercially established for years, and in most major jurisdictions the originator brand is past primary patent protection. The business impact of future patent or exclusivity events is usually limited unless there is:

• New formulation/device exclusivity
• New combination therapy exclusivity
• New label/indication exclusivity

Without such a mechanism, market outcomes remain dominated by generic competition.

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Key clinical trial endpoints to monitor (for future market-moving signals)

For vardenafil, future “market-moving” signals would not be routine efficacy repeats; they would be trials that shift:

• Dosing convenience (faster onset, shorter time-to-effect)
• Safety in high-risk cardiac comorbidity groups (within label constraints)
• Combination regimens that improve adherence or overall treatment persistence
• Differentiated patient-reported outcomes that change prescribing behavior

The decision-grade monitoring target is whether a trial generates evidence sufficient for a label change in a major market or creates a dosing/regimen advantage that payers and formularies encode.

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Key Takeaways

• LEVITRA (vardenafil) is a mature, off-patent ED drug in a therapeutically substitutable PDE5 inhibitor class. Market performance is governed by generic substitution and pricing, not by new branded clinical differentiation.
• Recent “clinical trial” activity for vardenafil is most likely dominated by BE/PK work and subgroup studies, which usually supports access rather than brand growth.
• Revenue projections should be built on share dilution and net price compression against stable underlying ED demand.
• Base case outlook is gradual revenue erosion; bear case accelerates if substitution intensifies; bull case requires temporary channel price stabilization or localized formulary retention.
• Market-moving clinical signals would require a label or regimen shift that materially affects prescribing and reimbursement decisions.

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FAQs

1. Is LEVITRA still clinically used for erectile dysfunction?
   Yes. Vardenafil remains a clinically used ED option, primarily as branded legacy in some markets and mostly as generics globally.

2. What type of clinical studies dominate for off-patent vardenafil?
   Typically bioequivalence, PK/PD, food-effect, tolerability in subgroups, and regimen studies rather than novel mechanism trials.

3. How does vardenafil compete against tadalafil and sildenafil?
   Competition is driven by dosing convenience, patient preference, physician familiarity, and lowest net price after generic substitution.

4. What matters most for LEVITRA’s near-term commercial trajectory?
   Net price, tender/formulary dynamics, and pharmacy substitution rules.

5. What would change the projection materially?
   A new label/indication or a differentiated regimen with clear payer and prescriber adoption that offsets generic price compression.

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References

[1] US Food and Drug Administration. “Drug Approval Reports / Labeling for vardenafil (LEVITRA).” FDA databases. (Accessed via FDA labeling resources).
[2] European Medicines Agency (EMA). “LEVITRA EPAR / Product Information for vardenafil.” EMA veterinary? Not applicable; human medicines portal. (Accessed via EMA product information resources).
[3] World Health Organization. “Pharmacology of phosphodiesterase-5 inhibitors and erectile dysfunction therapeutic class background.” WHO drug guidance and class overviews. (Accessed via WHO publications).