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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT:2009-009936-56 |
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The primary objective of this clinical trial is to study the ability of SAR407899 to increase the duration of penile erection in male patients with mild-moderate Erectile Dysfunction.
The secondary objectives of this clinical trial are to study the ability of SAR407899 to shorten increase the time to erection duration of penile erection in male patients with mild-moderate Erectile Dysfunction and to determine the overall safety and tolerability of SAR407899 in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Period 1: placebo Period 2: sildenafil Period 3: SAR407899 dose level 2 Period 4: SAR407899 dose level 1 |
|
| Sequence 2 | Experimental | Period 1: sildenafil Period 2: SAR407899 dose level 1 Period 3: placebo Period 4: SAR407899 dose level 2 |
|
| Sequence 3 | Experimental | Period 1: SAR407899 dose level 1 Period 2: SAR407899 dose level 2 Period 3: sildenafil Period 4: placebo |
|
| Sequence 4 | Experimental | Period 1: SAR407899 dose level 2 Period 2: placebo Period 3: SAR407899 dose level 1 Period 4: sildenafil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR407899 | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of penile rigidity during sexual stimulation | 4 hours following drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset of penile rigidity | 4 hours following drug administration | |
| Blood pressure | 12 hours following drug administration |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Lionel HOVSEPIAN, MD | SGS Aster Life Science Services - Paris-France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Paris | France |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Placebo | Drug | Oral administration |
|
| Sildenafil | Drug | Oral administration |
|
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |