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The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on erectile activity in males suffering from erectile dysfunction as well as examining the safety and toleration of the drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1; Study Period 1, 2, 3 or 4 | Placebo Comparator | Cohort 1: Exploring two single doses of PF-00446687 200 mg as well as sildenafil 100mg and placebo (double dummy design) |
|
| Cohort 2; study periods 1, 2, 3 or 4 | Placebo Comparator | Cohort 2: Exploring single doses of PF-00446687 20 mg - 175 mg. Subjects to receive two of 3 possible doses of PF-00446687 as well as a single dose of sildenafil 100mg and placebo (double dummy design). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-00446687 | Drug | Single 200mg dose as an oral solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assess effect of single doses of PF-00446687 on erectile function (using the Rigiscan+ device) | Day of dosing | |
| Evaluate subjective self-assessment of sexual interest and desire by means of a questionnaire | Day of dosing | |
| Diary of sexual activities | From day of dosing to 7 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| PK assessment of PF-00446687 ad sildenafil | Day of dosing | |
| Safety and toleration | Day of dosing to follow-up | |
| Assess variability of response and repeatability of design between 2 similar doses |
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Inclusion Criteria:
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 | Oslo | Norway | ||||
| 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 for oral solution |
|
| Placebo | Drug | Placebo for tablet |
|
| Sildenafil | Drug | Single oral dose 100 mg tablet |
|
| PF-00446687 | Drug | Single 125 mg dose as an oral solution |
|
| PF-00446687 | Drug | Single 175 mg dose as an oral solution |
|
| PF-00446687 | Drug | Single 20 mg dose as an oral solution |
|
| Placebo | Drug | Placebo for oral solution |
|
| Placebo | Drug | Placebo for tablet |
|
| Sildenafil | Drug | Single oral dose 100 mg tablet |
|
| Comparison of response to be assessed until 7 days post-dose |
| Assess agouti related protein levels in this population | Day of dosing |
| Belfast |
| Northern Ireland |
| BT9 6AD |
| United Kingdom |
| Pfizer Investigational Site | Leeds | WEST Yorkshire | LS2 9LH | 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 |
|---|---|
| C549342 | 1-((1-tert-butyl-4-(2,4-difluorophenyl)pyrrolidin-3-yl)carbonyl)-3,5-dimethyl-4-phenylpiperidin-4-ol |
| 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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