Potential Side Effects and Adverse Reactions of Vardenafil

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

At a glance

^ "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.

Pharmacokinetics and Pharmacodynamics

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 best ed treatments 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. F.

• Drug interactions include HIV protease inhibitors and antifungals.
• May interact with erythromycin and other antibiotics.
• Consult doctor before combining with other medications.

Matthes Leisnig, 04703, Germany Completed Praxis Fr.

Product	Dosage	Quantity + Bonus	Price
Levitra Original	20mg	4 Pills	45.87€ 43.69€	Buy
Viagra Generic	25mg	270 + 8 Pills	184.26€ 175.49€	Buy
Viagra Generic	200mg	10 Pills	40.96€ 39.01€	Buy
Cialis Generic	10mg	120 + 6 Pills	178.49€ 169.99€	Buy
Super Kamagra	160 mg	92 + 6 Pills	478.75€ 455.95€	Buy
Kamagra 100 mg	100 mg	84 + 6 Pills	264.44€ 251.85€	Buy
Viagra Professional	100mg	180 + 4 Pills	337.30€ 321.24€	Buy
Cialis Generic	5mg	120 + 6 Pills	132.92€ 126.59€	Buy
Levitra Generic	40mg	60 + 4 Pills	162.37€ 154.64€	Buy
Cialis Professional	40mg	180 + 4 Pills	618.23€ 588.79€	Buy

Dr.

Where to participate

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

• 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.

Pohl Dresden, 01129, Germany Completed Praxis Drs.

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

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,

Trial purpose

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 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. 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

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

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

• Vardenafil may be used as part of a broader erectile health program.
• Lifestyle changes, like exercise, can enhance medication effects.
• It is important to avoid excessive alcohol while on Vardenafil.
• The medication's safety profile is well-established.
• Patients with kidney problems should consult a healthcare provider.
• The drug is not effective without sexual stimulation.
• Vardenafil is contraindicated with some heart medications.
• A healthcare provider can determine the appropriate dose.
• Never take expired Vardenafil, as effectiveness declines.

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.

Trending on Pharmacy Times

Further, vardenafil causes lengthening of the QT interval. Therefore, it should not be taken by people taking other medications that affect the QT interval (such as amiodarone). Vardenafil was co-marketed by Bayer Pharmaceuticals, GlaxoSmithKline, and Schering-Plough under the brand name Levitra. As of 2005, the co-promotion rights of GSK on Levitra have been returned to Bayer in many markets outside the US. Thus, because of European Union trade rules, parallel imports might result in Vivanza sold next to Levitra in the EU.

Onset and Duration of Action

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).

Comparison with Other PDE5 Inhibitors

"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". 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.

Secondary Outcome

Explore without interruption, create a free account. Sexual Encounter Profile (SEP), questions 2 and 3date_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue: International Index of Erectile Function (IIEF) - EF (Erectile Function) domaindate_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue: Global Assessment Questionnaire (GAQ)date_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue: Safety and tolerabilitydate_rangeTime Frame:12 weeksenhanced_encryptionyesSafety Issue: Vardenafil, sold under the brand name Levitra among others, is a medication that is used for treating erectile dysfunction. Vardenafil's indications and contraindications are the same as with other PDE5 inhibitors; it is closely related in function to sildenafil citrate (Viagra) and tadalafil (Cialis). The difference between the vardenafil molecule and sildenafil citrate is a nitrogen atom's position and the change of sildenafil's piperazine ring methyl group to an ethyl group. Tadalafil is structurally different from both sildenafil and vardenafil.

Role in Erectile Dysfunction Management

Vardenafil's relatively short effective time is comparable to but somewhat longer than sildenafil's. Despite the structural differences between vardenafil and sildenafil, they both show similar ocular side effects due to their similar selectivity overlap with PDE6, an enzyme found in the eye. Beyond its indications for erectile dysfunction, vardenafil may be effective in the treatment of premature ejaculation, where it may significantly increase the time from penetration to ejaculation. The common, adverse drug reactions (side effects) are the same as with other PDE5 inhibitors. The frequent vardenafil-specific side-effect is nausea; the infrequent side effects are abdominal pain, back pain, photosensitivity, abnormal vision, eye pain, facial edema, hypotension, palpitation, tachycardia, arthralgia, myalgia, rash, itch, and priapism.

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One possibly serious, but rare, side effect with vardenafil is heart attack. Also, in rare cases, vardenafil use may cause priapism, a very painful emergency condition that can cause impotence if left untreated. In October 2007, the U.S. Food and Drug Administration (FDA) announced that a warning about possible deafness (sudden hearing loss) would be added to the drug labels of vardenafil, and other PDE5 inhibitors. Vardenafil should not be used by people taking nitrate medications, because combining them with vardenafil might provoke potentially life-threatening hypotension (low blood pressure).