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Clinical effectiveness is of the finest tools to evaluate treatment success and is combined of 3 elements: treatment effectivity, side effect profile and patient compliance. Since the 3 main PDE5i's differ in their molecular structure, therapeutic profile and pharmacokinetics, it seems logical to assume that combining 2 different PDE5i's at lower dosage each may be beneficial in comparison to a single PDE5i maximal dose therapy. The aim of this study is to compare the clinical effectiveness of combination therapy (2 lower-dose PDE5i's) versus single maximal dose PDE5i therapy.
This will be a prospective, randomized, 3-arm parallel trial on 60 males with erectile dysfunction (ED) that have never been exposed to PDE5i therapy (naïve patients) will be enrolled. In each group, every patient will receive three treatment regimes (Viagra®50mg & Cialis®10mg, Viagra®100mg, Cialis®20mg), in different sequences of administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maximal dose sildenafil | Active Comparator | 4 tablets of sildenafil 100mg are given for on demand use |
|
| Tadalafil 20mg maximal dose | Active Comparator | 4 tablets of tadalafil 20mg are given for on demand use |
|
| Combination half dose | Active Comparator | 4 tablets of sildenafil 50mg and tadalafil 10mg are given for on demand use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil 100 mg | Drug | 4 tablets for on demand use |
|
| Measure | Description | Time Frame |
|---|---|---|
| International Index of Erectile Function-Erectile Dysfunction (IIEF-ED) Domain Score | At each visit after use of different treatment each time | Every visit- altogether 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Erection Hardness Scale | At each visit after use of different treatment each time | Each visit- altogether 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilan Gruenwald, MD | Contact | 0097248542882 | i_gruenwald@rambam.health.gov.il | |
| Yoram Vardi, Prof. | Contact | 0097248542819 | yvardi@rambam.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Yoram Vardi, Prof. | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Campus | Haifa | Israel |
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| Tadalafil 20 mg | Drug | 4 tablets on demand |
|
|
| Combination half of maximal dose for sildenafil & tadalafil | Drug | 4 tablets on demand |
|
|
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002243 | Carbolines |
| D011725 | Pyridines |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006575 | Heterocyclic Compounds, 3-Ring |
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