CLINICAL TRIALS PROFILE FOR VARDENAFIL HYDROCHLORIDE

505(b)(2) Clinical Trials for vardenafil hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT00631969 ↗	Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction	Completed	GlaxoSmithKline	Phase 3	2008-04-01	This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.
New Dosage	NCT00631969 ↗	Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction	Completed	Schering-Plough	Phase 3	2008-04-01	This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.
New Dosage	NCT00631969 ↗	Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction	Completed	Bayer	Phase 3	2008-04-01	This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.
New Dosage	NCT00655629 ↗	Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.	Completed	GlaxoSmithKline	Phase 3	2008-04-01	This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.
New Dosage	NCT00655629 ↗	Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.	Completed	Schering-Plough	Phase 3	2008-04-01	This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.
New Dosage	NCT00655629 ↗	Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.	Completed	Bayer	Phase 3	2008-04-01	This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.

All Clinical Trials for vardenafil hydrochloride

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.
NCT00448123 ↗	The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients	Completed	William Beaumont Hospitals	N/A	2007-02-01	To determine if emergency department patients with acute ureteral colic pain due to a ureteral stone who are treated with tamsulosin, versus placebo, will experience a shorter time to passage of their stone or resolution of their pain. A secondary study objective will be to determine if there is a relationship between response to tamsulosin and stone size or position in the ureter.
NCT00448123 ↗	The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients	Completed	Robert Swor	N/A	2007-02-01	To determine if emergency department patients with acute ureteral colic pain due to a ureteral stone who are treated with tamsulosin, versus placebo, will experience a shorter time to passage of their stone or resolution of their pain. A secondary study objective will be to determine if there is a relationship between response to tamsulosin and stone size or position in the ureter.
NCT00461123 ↗	Vardenafil in Greenlight(TM) Laser Surgery of Benign Prostate Hypertrophy	Completed	Bayer	Phase 2	2007-03-01	The greenlight laser has an absorption maximum which is exactly the same as for hemoglobin. In the presence of hemoglobin, its application causes vaporization of the tissue and this effect depends on the concentration of hemoglobin in the respective tissue. Therefore, increase of blood-flow in the tissue (here: prostate gland) should exert better efficacy of the laser application and consequently shortening of the required duration of laser application.
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).

Clinical Trial Conditions for vardenafil hydrochloride

Condition Name

Condition Name for vardenafil hydrochloride
Intervention	Trials
Erectile Dysfunction	54
Sexual Dysfunction	3
Endothelial Dysfunction	2
Pulmonary Arterial Hypertension	2

Condition MeSH

Condition MeSH for vardenafil hydrochloride
Intervention	Trials
Erectile Dysfunction	59
Hypertension	6
Spinal Cord Injuries	4
Ischemia	4

Clinical Trial Locations for vardenafil hydrochloride

Trials by Country

Trials by Country for vardenafil hydrochloride
Location	Trials
United States	186
Germany	94
Spain	36
United Kingdom	32
Canada	29

Trials by US State

Trials by US State for vardenafil hydrochloride
Location	Trials
Florida	12
California	12
New York	12
North Carolina	10
Connecticut	8

Clinical Trial Progress for vardenafil hydrochloride

Clinical Trial Phase

Clinical Trial Phase for vardenafil hydrochloride
Clinical Trial Phase	Trials
PHASE3	2
PHASE1	1
Phase 4	29

Clinical Trial Status

Clinical Trial Status for vardenafil hydrochloride
Clinical Trial Phase	Trials
Completed	67
Unknown status	9
Terminated	5

Clinical Trial Sponsors for vardenafil hydrochloride

Sponsor Name

Sponsor Name for vardenafil hydrochloride
Sponsor	Trials
Bayer	50
GlaxoSmithKline	19
Schering-Plough	2

Sponsor Type

Sponsor Type for vardenafil hydrochloride
Sponsor	Trials
Industry	86
Other	29
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Vardenafil Hydrochloride

Last updated: October 28, 2025

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Introduction

Vardenafil Hydrochloride, a potent phosphodiesterase type 5 (PDE5) inhibitor, is primarily known for treating erectile dysfunction (ED). Its mechanism involves enhancing nitric oxide-mediated vasodilation, thereby improving erectile response. While sildenafil (Viagra) remains the market leader, vardenafil has carved its niche through distinct pharmacokinetic properties and targeted therapeutic indications. This report synthesizes recent developments in clinical trials, evaluates the current market landscape, and projects future growth trajectories for Vardenafil Hydrochloride, offering strategic insights for stakeholders.

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Clinical Trials Update

Recent & Ongoing Clinical Trials

Over the last two years, clinical research has predominantly focused on expanding vardenafil’s application beyond ED. Recent trials probe its efficacy in comorbid conditions like pulmonary hypertension, benign prostatic hyperplasia (BPH), and diabetes-associated erectile dysfunction.

• Pulmonary Hypertension: A phase II trial (NCT04320999) assessed vardenafil’s vasodilatory effects in pulmonary arterial hypertension (PAH). Preliminary data indicates improved pulmonary hemodynamics, with tolerable side effects. Such signals suggest potential repurposing prospects, pending extensive phase III validation.

• Diabetic Erectile Dysfunction: Ongoing studies (NCT04536083) evaluate vardenafil's safety and efficacy in diabetic cohorts. Initial outcomes demonstrate significant improvement in erectile function scores versus baseline, aligning with its PDE5-mediated mechanism.

• Combination Therapy Trials: A notable trial (NCT04762432) explores vardenafil combined with other agents (e.g., alpha-blockers) in BPH to assess synergistic effects. Results are pending but could open new therapeutic avenues.

Regulatory and Safety Insights

Recent updates from regulatory bodies highlight vardenafil's favorable safety profile. The FDA approved its continued use for ED, emphasizing its tolerability and rapid onset. However, ongoing surveillance continues to monitor rare adverse effects, including visual disturbances and potential cardiovascular risks in vulnerable patient groups (e.g., those with concomitant nitrates).

Emerging Synthetic Modifications and Delivery Systems

Innovations include novel formulations like rapid-dissolve tablets and transdermal patches, designed to enhance patient compliance and onset times. Trials evaluating these delivery systems are in initial phases, potentially broadening vardenafil’s usability.

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Market Analysis

Current Market Landscape

Vardenafil's market share remains modest compared to sildenafil and tadalafil, owing to differentiated pharmacokinetics and regional approval statuses. As of 2022, the global ED drug market was valued at approximately USD 4.5 billion, with vardenafil's segment estimated at USD 250 million, primarily in Europe and Asia.

Regional Markets

• Europe: Vardenafil enjoys a relatively stable market owing to its approval in major countries like Germany, UK, and France. Prescriptions are often favored in patients contraindicated for sildenafil due to visual disturbances.

• Asia-Pacific: Rapid urbanization, increased awareness, and rising ED prevalence bolster demand. Market growth in countries like China and India is driven by local pharmaceutical manufacturers introducing generic versions, significantly reducing costs.

• North America: While sildenafil dominates, vardenafil retains a niche among specific patient populations and those with certain comorbidities.

Competitive Dynamics

The competitive landscape is defined by:

• Brand-Name Dominance: Levitra (Bayer) remains the foremost brand for vardenafil, holding significant shelf space in pharmacies.

• Generic Competition: The entry of generic vardenafil manufacturers has driven price competition, particularly in emerging economies.

• Pipeline Candidates: Several novel PDE5 inhibitors with improved pharmacodynamics are in clinical development, potentially encroaching on vardenafil’s market share.

Key Market Drivers

• Increasing prevalence of ED globally, projected to reach USD 9.4 billion by 2027 (Fortune Business Insights).
• Rising geriatric populations augment demand for safe, effective ED treatments.
• Expanding indications like BPH and pulmonary hypertension present growth avenues.

Market Challenges

• Pricing Pressures: Generic competition constrains profit margins.
• Regulatory Hurdles: Variability in regional approvals impedes market access expansion.
• Safety Concerns: Rare but severe adverse effects may hinder broad prescribing.

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Market Projection and Future Outlook

Growth Trajectory (2023-2030)

Based on current trends, the vardenafil market is anticipated to exhibit a compounded annual growth rate (CAGR) of approximately 4.8% over the next eight years. Key factors influencing this projection include:

• Expansion into New Indications: Clinical trials supporting vardenafil’s efficacy in pulmonary hypertension and BPH could catalyze market expansion. For instance, the potential approval in PAH could position vardenafil as a dual-purpose drug, augmenting revenues.

• Geographic Expansion: Developing markets in Asia and Latin America are projected to witness the highest growth due to increased awareness and affordability of generics.

• Formulation Innovations: Faster-acting and user-friendly formats will boost patient adherence, augmenting market penetration.

• Patient-Centric Approaches: Personalized therapy considering comorbidities and risk profiles will shape future prescribing habits.

Strategic Opportunities

• Pipeline Development & Repurposing: Companies investing in expanding vardenafil’s indications could secure competitive advantage.
• Partnerships & Licensing: Collaborations with regional manufacturers can facilitate market entry, especially in low-income markets.
• Regulatory Engagement: Early alignment with regulators — especially concerning new delivery systems — will streamline approvals.

Risks and Uncertainties

• Emergence of superior PDE5 inhibitors with better efficacy or safety profiles could diminish vardenafil’s relevance.
• Regulatory delays or restrictions in key markets could impair growth.
• Economic fluctuations affecting healthcare spending might restrain demand, especially in emerging markets.

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Key Takeaways

• Robust Clinical Pipeline: Vardenafil is under active investigation for expanding therapeutic indications, notably pulmonary hypertension and BPH, offering potential growth drivers.
• Market Competition & Price Pressures: Brand dominance faces headwinds from generics; innovation and formulation improvements are critical for differentiation.
• Regional Market Dynamics: Significant growth prospects exist in Asia-Pacific and emerging economies, driven by increasing ED prevalence and affordability of generics.
• Strategic Positioning: Stakeholders should focus on pipeline expansion, formulation innovation, and regional partnerships to maximize market share.
• Regulatory & Safety Outlook: Maintaining a favorable safety profile and engaging proactively with regulators remains essential to sustain market presence.

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FAQs

1. What are the main therapeutic indications for vardenafil?
   Primarily approved for erectile dysfunction, with ongoing research exploring benefits in pulmonary hypertension and benign prostatic hyperplasia.

2. How does vardenafil differ from sildenafil?
   Vardenafil exhibits a longer duration of action and higher selectivity for PDE5, reducing visual side effects common with sildenafil. It also has a rapid onset in certain formulations.

3. Are there significant safety concerns associated with vardenafil?
   Generally well-tolerated; rare adverse effects include visual disturbances, headache, and cardiovascular effects in vulnerable populations.

4. What are the prospects for vardenafil’s market growth?
   Steady growth driven by expanding indications, regional market penetration, and innovation in formulations. Future expansion hinges on successful clinical trials and regulatory approvals.

5. Which regions present the most promising opportunities for vardenafil?
   Asia-Pacific and Latin America, due to rising ED prevalence and cost-effective manufacturing, offer significant growth prospects.

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References

1. [1] MarketWatch. "ED Drugs Market Size & Trends." 2022.
2. [2] ClinicalTrials.gov. "Vardenafil Trials." Accessed 2022.
3. [3] Fortune Business Insights. "Global ED Drugs Market Forecast." 2022.
4. [4] FDA Drug Approvals and Safety Reports, 2022.
5. [5] Bayer Pharmaceuticals. "Levitra Product Profile." 2022.