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
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.
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.
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.
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).

Clinical Trial Conditions for vardenafil hydrochloride

Condition Name

Condition Name for vardenafil hydrochloride
Intervention	Trials
Erectile Dysfunction	53
Sexual Dysfunction	3
Overactive Bladder	2
Spinal Cord Injury	2

Condition MeSH

Condition MeSH for vardenafil hydrochloride
Intervention	Trials
Erectile Dysfunction	58
Hypertension	6
Ischemia	4
Spinal Cord Injuries	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
New York	12
Florida	12
California	12
North Carolina	10
New Jersey	8

Clinical Trial Progress for vardenafil hydrochloride

Clinical Trial Phase

Clinical Trial Phase for vardenafil hydrochloride
Clinical Trial Phase	Trials
Phase 4	29
Phase 3	25
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for vardenafil hydrochloride
Clinical Trial Phase	Trials
Completed	66
Unknown status	9
Terminated	5

Clinical Trial Sponsors for vardenafil hydrochloride

Sponsor Name

Sponsor Name for vardenafil hydrochloride
Sponsor	Trials
Bayer	50
GlaxoSmithKline	19
Pfizer	2

Sponsor Type

Sponsor Type for vardenafil hydrochloride
Sponsor	Trials
Industry	86
Other	26
NIH	1

Vardenafil Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Vardenafil Hydrochloride

Vardenafil Hydrochloride, commonly known by its brand name Levitra, is a small molecule drug developed by Bayer AG for the treatment of erectile dysfunction (ED). It works by inhibiting the enzyme PDE5A, which regulates blood flow, thereby facilitating erections by relaxing the smooth muscles in the penis[5].

Clinical Trials Update

Trial on Vardenafil ODT and Nifedipine Interaction

A significant clinical trial involves the evaluation of the pharmacodynamic interaction between vardenafil orally disintegrating tablets (ODT) and nifedipine, a vasodilator used for hypertension. This double-blind, placebo-controlled, crossover study focuses on elderly male patients with both hypertension and ED. The trial assesses blood pressure and heart rate profiles over 8 hours post-dose and requires participants to be stable on nifedipine for at least 4 weeks prior to the study. The study includes 40 subjects, divided into two age groups: 65-69 years and 70-80 years[2].

Trial on Flexible Dosing of Vardenafil

Another clinical trial evaluates the efficacy, safety, and duration of erection of a flexible-dose regimen of vardenafil in patients with ED and dyslipidemia. This randomized, double-blind, placebo-controlled, parallel-group study is conducted over 12 weeks. Participants must have stable heterosexual relationships, be between 18 and 65 years old, and have been treated with a stable dose of a statin for at least three months. The study aims to assess the duration of erection using patient-reported stopwatch timings during sexual intercourse[4].

Mechanism of Action and Therapeutic Benefits

Vardenafil Hydrochloride targets the PDE5A enzyme, which is crucial for regulating blood flow. By inhibiting this enzyme, the drug helps relax the smooth muscles in the penis, increasing blood flow and facilitating erections. This mechanism has made it an effective treatment for ED, especially in patients with co-morbid conditions such as hypertension and dyslipidemia[5].

Market Analysis

Market Size and Forecast

The global Vardenafil Hydrochloride Trihydrate market is expected to grow significantly over the forecast period from 2024 to 2031. The market size is categorized based on application (pharmaceuticals, health products, and others), product types (0.99, 0.98, and others), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). The report indicates that the market will gain substantial shares during this period, driven by increasing demand for effective ED treatments[3].

Key Market Segments

• By Application: The pharmaceutical segment is expected to dominate the market due to the widespread use of Vardenafil Hydrochloride in treating ED.
• By Product: The 0.99 and 0.98 purity levels of Vardenafil Hydrochloride are significant segments, with the 0.99 purity level likely to hold a larger market share.
• By Geography: North America and Europe are anticipated to be major markets, followed by the Asia-Pacific region, which is expected to show rapid growth due to increasing healthcare spending and awareness about ED treatments[3].

Competitor Analysis

Key companies profiled in the market include Bayer AG, JSN Chemicals, Ruiteng Chem, and Chemlin. These companies are involved in the production and distribution of Vardenafil Hydrochloride and are expected to play a crucial role in shaping the market dynamics[3].

Market Trends and Drivers

Increasing Prevalence of ED

The growing prevalence of erectile dysfunction, particularly among older men and those with co-morbid conditions like hypertension and dyslipidemia, is a significant driver of the market. As the global population ages, the demand for effective ED treatments is expected to rise[4].

Advancements in Drug Delivery

The development of new drug delivery systems, such as orally disintegrating tablets (ODT), enhances patient compliance and convenience, contributing to market growth. These formulations offer quicker onset of action and ease of administration, making them more appealing to patients[2].

Regulatory Approvals

Vardenafil Hydrochloride has received regulatory approvals in multiple markets, including the European Union and China, which has validated its safety and efficacy profile. These approvals are crucial for expanding the drug's market reach[5].

Market Restraints and Challenges

Competition from Other PDE5 Inhibitors

The market for ED treatments is highly competitive, with other PDE5 inhibitors like sildenafil (Viagra) and tadalafil (Cialis) available. This competition can affect the market share of Vardenafil Hydrochloride[5].

Side Effects and Safety Concerns

While Vardenafil Hydrochloride is generally well-tolerated, it can have side effects such as headaches, flushing, and nasal congestion. Additionally, its interaction with other medications, such as nitrates, can pose safety risks, which may restrain market growth[2].

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the pharmaceutical industry. While it has disrupted supply chains and clinical trials, it has also accelerated the adoption of telemedicine and online healthcare services, potentially increasing access to ED treatments. The long-term impact on the Vardenafil Hydrochloride market will depend on how quickly the industry recovers and adapts to new healthcare delivery models[1].

Technological and R&D Trends

Clinical Trials and Research

Ongoing clinical trials, such as those evaluating the interaction between vardenafil and other medications, are crucial for expanding the therapeutic uses of Vardenafil Hydrochloride. Research into new formulations and delivery systems is also expected to drive innovation in the market[2][4].

Patent Landscape

The patent landscape for PDE5 inhibitors is complex, with multiple patents covering different aspects of these drugs. As patents expire, generic versions of Vardenafil Hydrochloride may enter the market, affecting the competitive dynamics[5].

Regional Analysis

North America and Europe

These regions are expected to dominate the market due to high healthcare spending, advanced healthcare infrastructure, and a large patient population seeking ED treatments.

Asia-Pacific

This region is anticipated to show rapid growth driven by increasing healthcare awareness, rising disposable incomes, and government initiatives to improve healthcare access.

Middle-East and Africa

These regions are expected to grow at a slower pace due to limited healthcare infrastructure and lower awareness about ED treatments, but they still present significant growth opportunities[3].

Key Takeaways

• Clinical Trials: Ongoing trials focus on the efficacy, safety, and interactions of Vardenafil Hydrochloride, particularly in elderly patients and those with co-morbid conditions.
• Market Growth: The global Vardenafil Hydrochloride Trihydrate market is projected to grow significantly from 2024 to 2031, driven by increasing demand for ED treatments.
• Market Segments: The pharmaceutical segment and 0.99 purity level are expected to dominate the market.
• Competitor Analysis: Key companies include Bayer AG, JSN Chemicals, Ruiteng Chem, and Chemlin.
• Market Trends: Advancements in drug delivery, regulatory approvals, and increasing prevalence of ED are key drivers.
• Challenges: Competition from other PDE5 inhibitors and safety concerns are significant restraints.

FAQs

What is the primary use of Vardenafil Hydrochloride?

Vardenafil Hydrochloride is primarily used for the treatment of erectile dysfunction (ED) by inhibiting the PDE5A enzyme and increasing blood flow to the penis.

Which companies are key players in the Vardenafil Hydrochloride market?

Key companies include Bayer AG, JSN Chemicals, Ruiteng Chem, and Chemlin.

What are the significant market segments for Vardenafil Hydrochloride?

The market is segmented by application (pharmaceuticals, health products), product type (0.99, 0.98 purity levels), and geographical regions (North America, Europe, Asia-Pacific, etc.).

How does the COVID-19 pandemic impact the Vardenafil Hydrochloride market?

The pandemic has had a mixed impact, disrupting supply chains and clinical trials but also increasing access to telemedicine and online healthcare services.

What are the main drivers of the Vardenafil Hydrochloride market?

The main drivers include the increasing prevalence of ED, advancements in drug delivery systems, and regulatory approvals in multiple markets.

Sources

1. Global Vardenafil Hydrochloride Trihydrate Market Report 2024. Cognitivemarketresearch.com.
2. Erectile Dysfunction - Bayer Clinical Trials. Clinicaltrials.bayer.com.
3. Vardenafil Hydrochloride Trihydrate Market Size, Share and Forecast. Marketresearchintellect.com.
4. Erectile Dysfunction | Study 12165 | Bayer - Clinical Trials Explorer. Clinicaltrials.bayer.com.
5. Pharmaceutical Insights: Vardenafil hydrochloride's R&D Progress. Synapse.patsnap.com.