Dr.
Medical uses
Porst Hamburg, 20354, Germany Completed Praxis Hr. Dr. E. U. Krohn Hamburg, 22177, Germany Completed Praxis Hr. F.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Original | 100mg | 12 Pills | 72.54€ 69.09€ | |
| Viagra Oral Jelly | 100mg | 21 Sachets | 78.66€ 74.91€ | |
| Levitra Generic | 60mg | 30 + 2 Pills | 109.43€ 104.22€ | |
| Kamagra | 100mg | 20 Pills | 86.09€ 81.99€ | |
| Viagra Generic | 100mg | 30 + 4 Pills | 60.91€ 58.01€ | |
| Levitra Soft Tabs | 20mg | 360 + 20 Pills | 682.21€ 649.72€ | |
| Kamagra Oral Jelly | 100mg | 63 + 7 Sachets | 224.18€ 213.50€ | |
| Viagra Super Active | 100mg | 20 + 4 Pills | 48.05€ 45.76€ | |
| Viagra Generic | 150mg | 180 + 10 Pills | 236.46€ 225.20€ | |
| Kamagra Oral Jelly | 100mg | 10 Sachets | 54.55€ 51.95€ | |
| Levitra Generic | 10mg | 180 + 10 Pills | 246.74€ 234.99€ | |
| Apcalis SX Oral Jelly | 20mg | 10 Sachets | 58.75€ 55.95€ | |
| Cialis Black | 80mg | 30 + 2 Pills | 89.11€ 84.87€ | |
| Cialis Generic | 60mg | 120 + 8 Pills | 240.18€ 228.74€ |
Matthes Leisnig, 04703, Germany Completed Praxis Fr.
Secondary Outcome
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".
Dosing Guidelines and Administration
^ "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". ^ "New erectile dysfunction treatment Staxyn approved in the U.S.
Ebola Bundibugyo Virus Outbreak in the DRC and Uganda: What Pharmacists Need to Know
- 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). Dr.
- 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.
W.
Trial purpose
^ 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 experience occasional erectile problems during their lives.
Pharmacokinetics and Pharmacodynamics
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. Key Participants Requirements Sex Male Age 18 cenforce100 - 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 20 mg vardenafil 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.
Drug Interactions to Consider
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. 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.
- 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.
| 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 |
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
Adverse reactions
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. One possibly serious, but rare, side effect with vardenafil is heart attack.
Safety Profile and Adverse Effects
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). Further, vardenafil causes lengthening of the QT interval.
Indications for Use
Therefore, it should not be taken by people taking other medications that buy tadalista 60 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. An orally disintegrating form, marketed as Staxyn and Levitra Soft, has been gaining approvals in countries such as the United States[11] and Canada. 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.
| Parameter | Value | Unit | Notes |
|---|---|---|---|
| Absorption Tmax | 0.5 to 1 hour | Hours | Time to peak plasma concentration |
| Bioavailability | Approximately 15% | Percentage | Fraction of dose reaching circulation |
| Half-life | ~4 to 5 hours | Hours | Duration of drug activity |
| Metabolism | Liver (via CYP3A4) | N/A | Main metabolic pathway |
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: