Storage, Stability, and Handling of Vardenafil Products

Archived from the original on April 6, 2012. ^ "Staxyn - New Innovation in Erectile Dysfunction Helps Younger Men Rise to the Occasion". U.S. Food and Drug Administration (FDA). ^ Tucker J, Fischer T, Upjohn L, Mazzera D, Kumar M (October 2018). "Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings". About clinical trials Why participate What to expect Additional information About clinical trials Why participate What to expect Additional information Bayer.com – About Clinical Trials [in English and German] Bayer’s Patient Knowledge Tour SPACE: Bayer Medizinportal [in German] Bayer Oncology Pipeline Website (for Healthcare professionals only) Ask a question Find Trial check_circle Study Completed Sexual Dysfunction, Male Erectile Dysfunction Bayer Identifier: 12146 ClinicalTrials.gov Identifier: NCT00377793 EudraCT Number: Not Available EU CT Number: Not Available Ask a question Download Results download Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II Trial purpose 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 sex medicine 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.

Latest CME

Dr. E. U. Krohn Hamburg, 22177, Germany Completed Praxis Hr. Dr.

From Rybelsus to the Ozempic Pill: What Pharmacists Need to Know About the Next Generation of Oral Semaglutide

F. Matthes Leisnig, 04703, Germany Completed Praxis Fr. Dr. W. Pohl Dresden, 01129, Germany Completed Praxis Drs. Key ed gel Participants Requirements Sex Male Age 18 - 64 Years Inclusion Criteria expand_more - Males 18 to 64 years - Males with ED for more than six months, according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance) - Stable heterosexual relationship for more than 6 months - The subject must make at least four attempts at sexual intercourse - Documented, dated, written Informed Consent Partner - Females 18 years, and older - Stable, heterosexual relationship for more than 6 months with male ED subject - Documented, dated, written Informed Consent - Motivated to support treatment for male partner's ED - Absence of significant sexual dysfunction as assessed by the total score on the FSFI16 > 23.55 Exclusion Criteria expand_more - Any unstable medical condition or substance abuse disorder that, in the opinion of the Investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study - Subjects who are taking nitrates or nitric oxide donors - Subjects who are taking the following inhibitors of cytochrome P 450 CYP 3A4: very potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents traconazole and ketoconazole (topical forms are allowed) or erythromycin - Known hypersensitivity to vardenafil - Presence of significant penile anatomical abnormalities (e.g.

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penile fibrosis or Peyronie's disease) - History of retinitis pigmentosa - Unstable angina pectoris - Severe chronic or acute liver disease - Premature ejaculator (defined as IELT < 2 minutes) - Subjects who were taking alpha blockers - Lost of vision of one eye because of NAION Trial summary Enrollment Goal 352 Trial Dates July 2006 - August 2007 Phase Phase 4 Could I Receive a placebo Yes Products Levitra (Vardenafil, BAY38-9456) Accepts Healthy Volunteer No Where to participate Status Institution Location Completed Praxis Hr. Policlinico Umberto I Roma, 00155, Italy Not yet recruiting A.O. Prof. Dr. H.

Key Participants Requirements

Careggi Firenze, 50139, Italy Completed Hospital Policlínico de Vigo - Clínica Povisa Vigo, 36211, Spain Completed Hospital Universitario de Canarias La Laguna, 38320, Spain Completed Hospital General Universitario de Alicante Alicante, 03010, Spain Completed Hospital Fundació Puigvert Barcelona, 08025, Spain Completed CAP Sarrià Barcelona, 08034, Spain Completed CHU de Liège LIEGE, 4000, Belgium Completed Dr Bongaerts - Dr Denier GENK, 3600, Belgium Completed Medisch Spectrum Twente, Locatie Ariensplein ENSCHEDE, 7511 JX, Netherlands Completed Deventer Ziekenhuis DEVENTER, 7415 EH, Netherlands Completed Private Practice Dr MK Dhanjee Newcastle, 2940, South Africa Completed Randles Road Medical Centre Durban, 4091, South Africa Completed Newkwa Medical Centre Durban, 4037, South Africa Completed Parklands Medical Centre - Durban Durban, 4091, South Africa Primary Outcome Maintenance of erection in men with ED, Improvement of their female partners sexual quality of life date_range Time Frame: 12 weeks enhanced_encryption Safety Issue: no Secondary Outcome SEP3 at weeks 4, 12, 18, and 24 of treatment compared to placebo date_range Time Frame: 24 weeks enhanced_encryption Safety Issue: no Additional Subject Diary questions at weeks 4, 12, 18, and 24, LOCF, and over entire treatment period compared to placebo date_range Time Frame: 24 weeks enhanced_encryption Safety Issue: no Global confidence question (GCQ) at weeks 12, and 24 of treatment compared to placebo. IIEF, TSS, mSLQQ-QOL, Partnership questionnaire (PFB20) date_range Time Frame: 24 weeks enhanced_encryption Safety Issue: no Trial design A randomized, double blind, parallel group study of vardenafil flexible dose versus erectile dysfunction pills over the counter placebo in males with erectile dysfunction and their female partners sexual quality of life. PARTNER II Trial Type Interventional Intervention Type Drug Trial Purpose Treatment Allocation Randomized Blinding Double Blind Assignment Parallel Assignment Trial Arms 2 Additional Information Click here and search for drug information provided by the FDA. Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. Click here to find information about studies related to Bayer Healthcare products conducted in Europe Click here to find results for studies related to Bayer Healthcare products.

Manufacturer Information and Brand History

Sexual Encounter Profile Question 2 and 3 and International Index of Erectile Function - Erectile Function domaindate_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue: Duration of erection leading to positive Sexual Encounter Profile Question 3date_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue: Safety and tolerabilitydate_rangeTime Frame:12 weeksenhanced_encryptionyesSafety Issue: Other patient diary based variablesdate_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue: The change from baseline in Fansworth Munsell (FM) 100 test total error score (TES) in both the left and right eyes for vardenafil treated subjects as compared to placebodate_rangeTime Frame:8 weeksenhanced_encryptionNoneSafety Issue: The change from baseline in Electroretinogram (ERG) as measured by amplitude and implicit time of b wave in both the left and right eyes for vardenafil treated subjects as compared to placebodate_rangeTime Frame:8 weeksenhanced_encryptionNoneSafety Issue: Change in the FM-100 total error score from baseline at approximately 6 hours and 24 hours post dosedate_rangeTime Frame:8 weeksenhanced_encryptionNoneSafety Issue: Safety and tolerability of 20 mg vardenafil after at least 15 oral doses of 20 mg vardenafil or placebo (dosed over approximately 8 weeks)date_rangeTime Frame:8 weeksenhanced_encryptionNoneSafety Issue: ERG and FM-100 total error score from baseline at approximately 2 hours following one dose of sildenafil 200 mgdate_rangeTime Frame:8 weeksenhanced_encryptionNoneSafety Issue: The Bayer Clinical Trials Registry and Results Database website contains information on clinical trials sponsored by Bayer, and is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. The information contained within the website is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before making any decisions on their treatment. Healthcare professionals should always refer to the specific labeling information approved for the patient's country or region. The data on the website should not be considered as prescribing advice. Porst Hamburg, 20354, Germany Completed Praxis Hr. Dr. E.

At a glance

The data on the website may differ from published or presented data and are a reflection of the limited information provided there. The results from a single trial need to be considered in the context of the full clinical research for a drug. All reasonable precautions have been taken to ensure the accuracy, security and confidentiality of the information available through the site. Bayer may amend the information at any time without notice. aDepartment of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, 77 Mitropoleos str., 546 22 Thessaloniki, Greece DOI: 10.1016/j.eururo.2004.01.014 External LinkAlso available on ScienceDirect External Link Vardenafil for Treatment of Men With Erectile Dysfunction: Efficacy and Safety in a Randomized, Double-Blind, Placebo-Controlled Trial Safety and efficacy of vardenafil for the treatment of men with erectile dysfunction after radical retropubic prostatectomy Vardenafil, a new phosphodiesterase type 5 inhibitor, in the treatment of erectile dysfunction in men with diabetes: a multicenter double-blind placebo-controlled fixed-dose study Influence of age on the efficacy and safety of vardenafil, a novel phosphodiesterase-5 inhibitor, for the treatment of erectile dysfunction The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction Achieving treatment optimization with sildenafil citrate (Viagra(R)) in patients with erectile dysfunction The potential value of erectile dysfunction inquiry and management Hellstrom, W.

Storage and Handling Instructions

U.

Contraindication	Explanation	Note
Nitrate medication use	Can cause severe hypotension	Avoid use within 24 hours of nitrates
Severe cardiovascular disease	Increased risk of adverse cardiac events	Consult with cardiologist
Hypersensitivity to Vardenafil	Known allergy to the drug or ingredients	Discontinue if allergic reactions occur
Liver impairment	Reduced metabolism leading to higher drug levels	Dose adjustment may be necessary

Krohn Hamburg, 22177, Germany Completed Praxis Hr. Dr.

• Psychological effects like anxiety may influence response.
• Partner communication can improve treatment outcomes.
• Stress reduction techniques may complement medication.

F. Matthes Leisnig, 04703, Germany Completed Praxis Fr.

Side Effect	Frequency	Severity	Notes
Headache	Common	Mild to moderate	Usually transient
Flushing	Common	Mild	Facial redness
Nasal Congestion	Common	Mild	Sinus-related effects
Dizziness	Less common	Mild	Especially when standing quickly
Visual Disturbances	Rare	Mild	Changes in color perception or blurred vision

Dr.

Adverse reactions

Archived from the original on April 6, 2012. ^ "Staxyn - New Innovation in Erectile Dysfunction Helps Younger Men Rise to the Occasion". U.S. Food and Drug Administration (FDA). ^ Tucker J, Fischer T, Upjohn L, Mazzera D, Kumar M (October 2018).

Comparison with Other PDE5 Inhibitors

"Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings". About clinical trials Why participate What to expect Additional information About clinical trials Why participate What to expect Additional information Bayer.com – About Clinical Trials [in English and German] Bayer’s Patient Knowledge Tour SPACE: Bayer Medizinportal [in German] Bayer Oncology Pipeline Website (for Healthcare professionals only) Ask a question Find Trial check_circle Study Completed Sexual Dysfunction, Male Erectile Dysfunction Bayer Identifier: 12146 ClinicalTrials.gov Identifier: NCT00377793 EudraCT Number: Not Available EU CT Number: Not Available Ask a question Download Results download Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II Trial purpose 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 sex medicine experience occasional erectile problems during their lives. However, when this becomes a continued problem, it can affect both the man and his female partner. W. Pohl Dresden, 01129, Germany Completed Praxis Drs.

Region	Patent Expiry Year	Generic Availability	Major Manufacturers	Notes
United States	2027	Yes	Bayer, Teva, Mylan	Patent nearing expiration, generics emerging
European Union	2027	Yes	Bayer, Sandoz	Widely accessible
Asia	Varies	Yes or No	Multiple local manufacturers	Availability may differ by country

Careggi Firenze, 50139, Italy Completed Hospital Policlínico de Vigo - Clínica Povisa Vigo, 36211, Spain Completed Hospital Universitario de Canarias La Laguna, 38320, Spain Completed Hospital General Universitario de Alicante Alicante, 03010, Spain Completed Hospital Fundació Puigvert Barcelona, 08025, Spain Completed CAP Sarrià Barcelona, 08034, Spain Completed CHU de Liège LIEGE, 4000, Belgium Completed Dr Bongaerts - Dr Denier GENK, 3600, Belgium Completed Medisch Spectrum Twente, Locatie Ariensplein ENSCHEDE, 7511 JX, Netherlands Completed Deventer Ziekenhuis DEVENTER, 7415 EH, Netherlands Completed Private Practice Dr MK Dhanjee Newcastle, 2940, South Africa Completed Randles Road Medical Centre Durban, 4091, South Africa Completed Newkwa Medical Centre Durban, 4037, South Africa Completed Parklands Medical Centre - Durban Durban, 4091, South Africa Primary Outcome Maintenance of erection in men with ED, Improvement of their female partners sexual quality of life date_range Time Frame: 12 weeks enhanced_encryption Safety Issue: no Secondary Outcome SEP3 at weeks 4, 12, 18, and 24 of treatment compared to placebo date_range Time Frame: 24 weeks enhanced_encryption Safety Issue: no Additional Subject Diary questions at weeks 4, 12, 18, and 24, LOCF, and over entire treatment period compared to placebo date_range Time Frame: 24 weeks enhanced_encryption Safety Issue: no Global confidence question (GCQ) at weeks 12, and 24 of treatment compared to placebo. IIEF, TSS, mSLQQ-QOL, Partnership questionnaire (PFB20) date_range Time Frame: 24 weeks enhanced_encryption Safety Issue: no Trial design A randomized, double blind, parallel group study of vardenafil flexible dose versus erectile dysfunction pills over the counter placebo in males with erectile dysfunction and their female partners sexual quality of life.

• Not a cure for erectile dysfunction, but a treatment option.
• Underlying causes like diabetes or heart disease should be addressed.
• Lifestyle changes may enhance medication effectiveness.

PARTNER II Trial Type Interventional Intervention Type Drug Trial Purpose Treatment Allocation Randomized Blinding Double Blind Assignment Parallel Assignment Trial Arms 2 Additional Information Click here and search for drug information provided by the FDA.

• Vardenafil's chemical structure contributes to its potency.
• It is manufactured by Bayer, a reputable pharmaceutical company.
• Patients should avoid combining Vardenafil with high-fat meals.
• The drug's metabolism involves the liver, requiring caution.
• It can cause temporary vision changes, like color discrimination.
• Vardenafil is marketed in several countries worldwide.
• It is not intended for use in women or animals.
• Patients should seek medical advice if they experience allergic reactions.
• Regular follow-up helps optimize ED treatment outcomes.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Medical uses

Cardiovascular Safety Data

Click here to find information about studies related to Bayer Healthcare products conducted in Europe Click here to find results for studies related to Bayer Healthcare products.

• Bayer Vardenafil is a medication used to treat erectile dysfunction in men.
• It belongs to the phosphodiesterase type 5 (PDE5) inhibitors class.
• Vardenafil enhances blood flow to the penis during sexual stimulation.
• It is marketed under various brand names, including Levitra.
• The medication is typically taken 25-20 minutes before activity.
• Common side effects include headache, flushing, and nasal congestion.
• It may interact with nitrate medications, causing dangerous blood pressure drops.
• Vardenafil should be used with caution by those with heart or liver issues.
• The recommended dosage varies based on individual health factors.

Sexual Encounter Profile Question 2 and 3 and International Index of Erectile Function - Erectile Function domaindate_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue: Duration of erection leading to positive Sexual Encounter Profile Question 3date_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue: Safety and tolerabilitydate_rangeTime Frame:12 weeksenhanced_encryptionyesSafety Issue: Other patient diary based variablesdate_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue: The change from baseline in Fansworth Munsell (FM) 100 test total error score (TES) in both the left and right eyes for vardenafil treated subjects as compared to placebodate_rangeTime Frame:8 weeksenhanced_encryptionNoneSafety Issue: The change from baseline in Electroretinogram (ERG) as measured by amplitude and implicit time of b wave in both the left and right eyes for vardenafil treated subjects as compared to placebodate_rangeTime Frame:8 weeksenhanced_encryptionNoneSafety Issue: Change in the FM-100 total error score from baseline at approximately 6 hours and 24 hours post dosedate_rangeTime Frame:8 weeksenhanced_encryptionNoneSafety Issue: Safety and tolerability of 20 mg vardenafil after at least 15 oral doses of 20 mg vardenafil or placebo (dosed over approximately 8 weeks)date_rangeTime Frame:8 weeksenhanced_encryptionNoneSafety Issue: ERG and FM-100 total error score from baseline at approximately 2 hours following one dose of sildenafil 200 mgdate_rangeTime Frame:8 weeksenhanced_encryptionNoneSafety Issue: The Bayer Clinical Trials Registry and Results Database website contains information on clinical trials sponsored by Bayer, and is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. The information contained within the website is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before making any decisions on their treatment. Healthcare professionals should always refer to the specific labeling information approved for the patient's country or region. The data on the website should not be considered as prescribing advice. The data on the website may differ from published or presented data and are a reflection of the limited information provided there.

Tainted supplements

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. Key ed gel Participants Requirements Sex Male Age 18 - 64 Years Inclusion Criteria expand_more - Males 18 to 64 years - Males with ED for more than six months, according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance) - Stable heterosexual relationship for more than 6 months - The subject must make at least four attempts at sexual intercourse - Documented, dated, written Informed Consent Partner - Females 18 years, and older - Stable, heterosexual relationship for more than 6 months with male ED subject - Documented, dated, written Informed Consent - Motivated to support treatment for male partner's ED - Absence of significant sexual dysfunction as assessed by the total score on the FSFI16 > 23.55 Exclusion Criteria expand_more - Any unstable medical condition or substance abuse disorder that, in the opinion of the Investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study - Subjects who are taking nitrates or nitric oxide donors - Subjects who are taking the following inhibitors of cytochrome P 450 CYP 3A4: very potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents traconazole and ketoconazole (topical forms are allowed) or erythromycin - Known hypersensitivity to vardenafil - Presence of significant penile anatomical abnormalities (e.g. penile fibrosis or Peyronie's disease) - History of retinitis pigmentosa - Unstable angina pectoris - Severe chronic or acute liver disease - Premature ejaculator (defined as IELT < 2 minutes) - Subjects who were taking alpha blockers - Lost of vision of one eye because of NAION Trial summary Enrollment Goal 352 Trial Dates July 2006 - August 2007 Phase Phase 4 Could I Receive a placebo Yes Products Levitra (Vardenafil, BAY38-9456) Accepts Healthy Volunteer No Where to participate Status Institution Location Completed Praxis Hr.

Recent COVID-19 Vaccination Associated With Nearly Half the Risk of Household Transmission

Policlinico Umberto I Roma, 00155, Italy Not yet recruiting A.O. Prof. Dr. H. Porst Hamburg, 20354, Germany Completed Praxis Hr. The results from a single trial need to be considered in the context of the full clinical research for a drug. All reasonable precautions have been taken to ensure the accuracy, security and confidentiality of the information available through the site. Bayer may amend the information at any time without notice. aDepartment of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, 77 Mitropoleos str., 546 22 Thessaloniki, Greece DOI: 10.1016/j.eururo.2004.01.014 External LinkAlso available on ScienceDirect External Link Vardenafil for Treatment of Men With Erectile Dysfunction: Efficacy and Safety in a Randomized, Double-Blind, Placebo-Controlled Trial Safety and efficacy of vardenafil for the treatment of men with erectile dysfunction after radical retropubic prostatectomy Vardenafil, a new phosphodiesterase type 5 inhibitor, in the treatment of erectile dysfunction in men with diabetes: a multicenter double-blind placebo-controlled fixed-dose study Influence of age on the efficacy and safety of vardenafil, a novel phosphodiesterase-5 inhibitor, for the treatment of erectile dysfunction The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction Achieving treatment optimization with sildenafil citrate (Viagra(R)) in patients with erectile dysfunction The potential value of erectile dysfunction inquiry and management Hellstrom, W.