An orally disintegrating form, marketed as Staxyn and Levitra Soft, has been gaining approvals in countries such as the United States[11] and Canada. The US Food and Drug Administration (FDA) has found vardenafil and other synthetic PDE5 inhibitors in numerous products marketed as "herbal" supplements or "all natural" products for male enhancement. ^ a b c d "Levitra (vardenafil hydrochloride) tablets, for oral use Initial U.S. Approval: 2003". ^ "Levitra (Vardenafil) is A Drug Used to Treat Erectile Problems in Men" (in German). "Potency, selectivity, and consequences of nonselectivity of PDE inhibition". ^ "FDA Announces Revisions to Labels for Cialis, Levitra and Viagra". Archived from the original on July 9, 2009. "Pharmacology and drug interaction effects of the phosphodiesterase 5 inhibitors: focus on alpha-blocker interactions".

• Can be used as needed rather than daily dosing.
• Daily low-dose regimens are not standard for this drug.
• On-demand use is typical for most patients.

"The QT Interval and Selection of Alpha-Blockers for Benign Prostatic Hyperplasia".

Primary Outcome

H. Porst Hamburg, 20354, Germany Completed Praxis Hr. Dr. E. U.

Patient Counseling Points

Krohn Hamburg, 22177, Germany Completed Praxis Hr. Dr. F. Matthes Leisnig, 04703, Germany Completed Praxis Fr. Dr.

Storage and Handling Instructions

W. Pohl Dresden, 01129, Germany Completed Praxis Drs. 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 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. ^ "New erectile dysfunction treatment Staxyn approved in the U.S.

- Pharmaceutical Processing". 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, vidalista 20mg uk Kumar M (October 2018).

Ghi chú

An orally disintegrating form, marketed as Staxyn and Levitra Soft, has been gaining approvals in countries such as the United States[11] and Canada. The US Food and Drug Administration (FDA) has found vardenafil and other synthetic PDE5 inhibitors in numerous products marketed as "herbal" supplements or "all natural" products for male enhancement. ^ a b c d "Levitra (vardenafil hydrochloride) tablets, for oral use Initial U.S. Approval: 2003". ^ "Levitra (Vardenafil) is A Drug Used to Treat Erectile Problems in Men" (in German).

Efficacy in Clinical Trials

"Potency, selectivity, and consequences of nonselectivity of PDE inhibition". ^ "FDA Announces Revisions to Labels for Cialis, Levitra and Viagra". Archived from the original on July 9, 2009. "Pharmacology and drug interaction effects of the phosphodiesterase 5 inhibitors: focus on alpha-blocker interactions". "The QT Interval and Selection of Alpha-Blockers for Benign Prostatic Hyperplasia".

Contraindications and Warnings

^ "New erectile dysfunction treatment Staxyn approved in the U.S. - Pharmaceutical Processing". Archived from the original on April 6, 2012. ^ "Staxyn - New Innovation in Erectile Dysfunction Helps Younger Men Rise to the Occasion". U.S. "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.

Phản ứng bất lợi

Food and Drug Administration (FDA). ^ Tucker J, Fischer T, Upjohn L, Mazzera D, vidalista 20mg uk 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.

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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.

Role in Erectile Dysfunction Management

Key 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 medicine for erectile dysfunction 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. Policlinico Umberto I Roma, 00155, Italy Not yet recruiting A.O. Prof. Dr. 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.

Secondary Outcome

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. 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. Key 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 medicine for erectile dysfunction 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. Policlinico Umberto I Roma, 00155, Italy Not yet recruiting A.O. Prof.

• Priapism (prolonged erection) is a rare but serious risk.
• Seek emergency care if erection lasts over 4 hours.
• Sudden vision or hearing loss requires immediate attention.

Dr. H. Porst Hamburg, 20354, Germany Completed Praxis Hr. Dr. E. U. Krohn Hamburg, 22177, Germany Completed Praxis Hr. Dr.

• Bayer Vardenafil is available by prescription only.
• It is often used as an alternative to sildenafil (Viagra).
• The medication improves erectile function in many men with ED.
• It should not be used more than once in a 24-hour period.
• Possible side effects include dizziness and upset stomach.
• Patients should report prolonged erections lasting over 4 hours.
• Alcohol consumption can increase the risk of side effects.
• Use Vardenafil under medical supervision for safety.
• It is not approved for use in women or children.

F.

• Using Bayer Vardenafil without a prescription is not recommended.
• The medication's dosage should be tailored by a healthcare provider.
• It is not a cure for erectile dysfunction, but a treatment aid.
• Vardenafil may be less effective in men over 65 years old.
• The drug is absorbed quickly, making timing important.
• Patients with pre-existing eye conditions should consult a doctor.
• Side effects can include muscle pain and mild rash.
• It should be taken with water, not with alcohol or grapefruit juice.
• Avoid driving or operating heavy machinery until effects are known.

Matthes Leisnig, 04703, Germany Completed Praxis Fr. Dr. W. Pohl Dresden, 01129, Germany Completed Praxis Drs. 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 placebo in males with erectile dysfunction and their female partners sexual quality of life.

Latest CME

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. 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. 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.