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| Name | Class |
|---|---|
| Sexual Medicine Society of North America Inc. | UNKNOWN |
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The purpose of this research study is to look at whether Eroxon® gel when used together with tadalafil, may help improve erectile function in men ages 18 to 40 who have type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care (Tadalafil) + Eroxon® Gel Group | Experimental | Participants assigned to this arm will continue to use tadalafil as prescribed per standard of care treatment and will also be instructed to use Eroxon® gel prior to each sexual encounter throughout the 12-week study period. |
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| Tadalafil (Control) Group | Active Comparator | Participants assigned to this arm will continue their standard-of-care treatment with tadalafil as prescribed. No study-specific changes will be made to their routine clinical management. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eroxon® | Device | Participants will receive a 12-week supply of Eroxon® and will be instructed to apply the gel prior to each sexual encounter as directed at enrollment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Erectile Functioning | Erectile function assessed using the International Index of Erectile Function-5 (IIEF-5), a validated 5-item patient-reported questionnaire. Total scores range from 5 to 25, with higher scores indicating better erectile function. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Adherence | Patient adherence assessed using the Medication Adherence Report Scale-5 (MARS-5), a validated five-item self-report questionnaire measuring both intentional and unintentional non-adherence. Each item is scored on a 5-point Likert scale, with total scores ranging from 5 to 25, and higher scores indicating better adherence. | Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley Gray | Contact | 786-909-3719 | ajg2940@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sonjia Kenya, E.D | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Don Soffer Clinical Research Building | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| tadalafil | Drug | Tadalafil is administered as standard of care at dose and schedule determined by the treating clinician. |
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| Change in Partner Acceptability | Partner acceptability assessed using the Sexual Life (ISL) scale, a validated 11-item questionnaire evaluating satisfaction and acceptability related to sexual activity. Each item is scored on a 5-point Likert scale, with total scores ranging from 5 to 25, with higher scores indicating greater partner satisfaction and acceptability. | Baseline to Week 12 |
| D004700 | Endocrine System Diseases |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |