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To determine the improvement in the self-esteem domain score of the Self-Esteem/Overall Relationship (SEAR) questionnaire and the improvement in erectile function (obtained from the Erectile Function [EF] domain of the International Index of Erectile Function [IIEF]). Furthermore, to determine if the improvement obtained in self-esteem was related to the main erectile dysfunction (ED) co-morbidities type and/or number.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 2 | Placebo Comparator |
| |
| Arm 1 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sildenafil | Drug | sildenafil 50 mg tablet by mouth 1 hour before sexual activity for 12 weeks; the dose could be increased to 100 mg or decreased to 25 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the Self-esteem domain of the SEAR questionnaire | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the change in the SE domain of the SEAR questionnaire and the erectile function domain of the IIEF by number of ED co-morbidities | Week 12 | |
| Differences in the global efficacy assessment question overall and by type of co-morbidity |
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Inclusion Criteria:
-Men with a documented clinical diagnosis of ED confirmed by a Sexual Health Inventory-Male (SHI-M) score of 21 or less and who have a sexual partner for the duration of the study were included.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Oulu | 90100 | Finland | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| placebo | Drug | placebo tablet by mouth 1 hour before sexual activity for 12 weeks |
|
| Week 12 |
| Differences in the global satisfaction assessment questions overall and by type of co-morbidity | Week 12 |
| Comparisons between treatments in the SE domain of the SEAR questionnaire by type of co-morbidity (hypertension, hyperlipidemia, diabetes mellitus, benign prostatic hyperplasia, depression) | Week 12 |
| Changes in the sexual activity domain of the SEAR questionnaire overall and by type of co-morbidity | Week 12 |
| Changes in the relationship domain of the SEAR questionnaire overall and by type of co-morbidity | Week 12 |
| Changes of the SEAR questions overall and by type of co-morbidity | Week 12 |
| Changes of the IIEF questions overall and by type of co-morbidity | Week 12 |
| Changes of the IIEF domains overall and by type of co-morbidity | Week 12 |
| Degrees of severity in the IIEF erectile function | Week 12 |
| Correlation between the change in the SE domain of the SEAR questionnaire and the erectile function domain of the IIEF overall and by type of co-morbidity | Week 12 |
| Changes in the questions from the event log overall and by type of co-morbidity | Week 12 |
| Correlation between each success rate derived from the event log and the change in the SE domain of the SEAR questionnaire overall and by type of co-morbidity | Week 12 |
| Differences in the intercourse success rates derived from the event log overall and by type of comorbidity | Week 12 |
| Tampere |
| Finland |
| Pfizer Investigational Site | Turku | 20110 | Finland |
| Pfizer Investigational Site | Clermont-Ferrand | 63023 | France |
| Pfizer Investigational Site | LE Kremlin Bicentre | 94275 | France |
| Pfizer Investigational Site | Lyon | 69437 | France |
| Pfizer Investigational Site | Marseille | 13915 | France |
| Pfizer Investigational Site | Neuilly-sur-Seine | 92200 | France |
| Pfizer Investigational Site | Nice | 06002 | France |
| Pfizer Investigational Site | Nîmes | 30029 | France |
| Pfizer Investigational Site | Toulouse | 31403 | France |
| Pfizer Investigational Site | Bari | 70124 | Italy |
| Pfizer Investigational Site | Catania | 95124 | Italy |
| Pfizer Investigational Site | Gallarate (VA) | 21013 | Italy |
| Pfizer Investigational Site | Modena | 41100 | Italy |
| Pfizer Investigational Site | Padova | 35128 | Italy |
| Pfizer Investigational Site | Roma | 00100 | Italy |
| Pfizer Investigational Site | Siena | 53100 | Italy |
| Pfizer Investigational Site | Torino | 10126 | Italy |
| Pfizer Investigational Site | Krakow | Poland |
| Pfizer Investigational Site | Lodz | Poland |
| Pfizer Investigational Site | Lublin | Poland |
| Pfizer Investigational Site | Olsztyn | Poland |
| Pfizer Investigational Site | Szczecin | Poland |
| Pfizer Investigational Site | Warsaw | Poland |
| Pfizer Investigational Site | Barnaul | 656099 | Russia |
| Pfizer Investigational Site | Moscow | 105425 | Russia |
| Pfizer Investigational Site | Moscow | 117036 | Russia |
| Pfizer Investigational Site | Moscow | 121552 | Russia |
| Pfizer Investigational Site | Moscow | 123448 | Russia |
| Pfizer Investigational Site | Moscow | 125101 | Russia |
| Pfizer Investigational Site | Moscow | 125206 | Russia |
| Pfizer Investigational Site | Moscow | 127411 | Russia |
| Pfizer Investigational Site | Moscow | Russia |
| Pfizer Investigational Site | Nizhny Novgorod | Russia |
| Pfizer Investigational Site | Novosibirsk | 630003 | Russia |
| Pfizer Investigational Site | Novosibirsk | 630087 | Russia |
| Pfizer Investigational Site | Rostov-on-Don | 344068 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 193318 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 197089 | Russia |
| Pfizer Investigational Site | Saint Petersburg | Russia |
| Pfizer Investigational Site | Yekaterinburg | Russia |
| Pfizer Investigational Site | San Juan | Alicante | 03550 | Spain |
| Pfizer Investigational Site | Barakaldo | Vizcaya | 48903 | Spain |
| Pfizer Investigational Site | Barcelona | 08036 | Spain |
| Pfizer Investigational Site | Madrid | 28007 | Spain |
| Pfizer Investigational Site | Madrid | 28041 | Spain |
| Pfizer Investigational Site | Madrid | 28046 | Spain |
| Pfizer Investigational Site | Valencia | 46009 | Spain |
| Pfizer Investigational Site | Valencia | 46010 | Spain |
| Pfizer Investigational Site | Zaragoza | 50009 | Spain |
| Pfizer Investigational Site | Karlshamn | 374 35 | Sweden |
| Pfizer Investigational Site | Malmö | 205 02 | Sweden |
| Pfizer Investigational Site | Skövde | 541 30 | Sweden |
| Pfizer Investigational Site | Stockholm | 171 76 | Sweden |
| Pfizer Investigational Site | Värnamo | 331 85 | Sweden |
| Pfizer Investigational Site | Västervik | 593 81 | Sweden |
| Pfizer Investigational Site | Bodelwyddan | Denbighshire | LL18 5UJ | United Kingdom |
| Pfizer Investigational Site | South Yorkshire | DN1 2ET | United Kingdom |
| Pfizer Investigational Site | Belmont | Durham | DH1 2QP | United Kingdom |
| Pfizer Investigational Site | Blackpool | Lancashire | FY4 3AD | United Kingdom |
| Pfizer Investigational Site | Urmston | Manchester | M41 0UH | United Kingdom |
| Pfizer Investigational Site | Ashford | Middlesex | TW15 3EA | United Kingdom |
| Pfizer Investigational Site | Nr Lichfield | Staffordshire | WS14 9JL | United Kingdom |
| Pfizer Investigational Site | Addlestone | Surrey | KT15 2BH | United Kingdom |
| Pfizer Investigational Site | Taunton | TA1 5DA | United Kingdom |
| 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 |
| 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 |
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