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They study lost funding and decided to close the study down.
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| Name | Class |
|---|---|
| Acerus Pharmaceuticals Corporation | INDUSTRY |
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To determine if testosterone deficient men who are using daily Tadalafil (a phosphodiesterase-5 Inhibitor), will have a significant improvement in erectile function and satisfaction with erectile dysfunction treatment when using on-demand Testosterone Nasal Gel (TNG) prior to sexual activity compared to placebo.
The purpose of this study is to determine if testosterone deficient men whose primary symptom is erectile dysfunction, who are using daily Tadalafil (a phosphodiesterase-5 Inhibitor), will have a significant improvement in erectile function and satisfaction with erectile dysfunction treatment when using on-demand Testosterone Nasal Gel (TNG) prior to sexual activity compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natesto | Active Comparator | Natesto™ is a testosterone nasal gel that is FDA approved to treat low testosterone. It delivers testosterone through the nasal passages and it is then absorbed into the blood stream. The nasal pump is placed at the opening of each nostril and then the participant would press down on the nasal pump to apply the gel. Each application takes about 10 seconds and the nasal pump applies a thin layer of gel that absorbs through the lining of the nose. |
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| Placebo | Placebo Comparator | This study involves a placebo. The placebo will look like the Natesto™ nasal pump and will contain a nasal gel, but without any active ingredients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natesto Nasal Product | Drug | Nasal Gel used for 90 days then crossed over to placebo gel |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Erectile Function and Sexual Intercourse Satisfaction Total Scores Recorded at Baseline and End of Study. | The primary endpoint of the study will be mean change in erectile function and satisfaction with sexual intercourse using the validated SHIM questionnaire. This questionnaire has been used extensively in clinical trials evaluating PDE5i for ED and is also used very commonly in the clinical practice. The SHIM Is a 5 item questionnaire that assesses the ability to get and maintain an erection sufficient for intercourse (Q1-Q4) and Q5 which assesses patient satisfaction. Each question is scored 0 to 5 with a total maximum score of 25. The investigators will look at the answers to all 5 questions and a higher score is interpreted as a better outcome. | At Baseline and at the end of the study (Day 180) |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Sexual Function Scores Recorded at Baseline and End of Study | Secondary outcomes will include a comparison of answers to question #2 in the Sexual Encounter Profile (SEP): Was the participant able to insert the penis into the partner's vagina? This is a question asked at baseline and at the end of the study. Answers are recorded as Yes or No and Yes is interpreted as a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
The study involves a diagnosis of Erectile Dysfunction. Therefore, all patients must have a penis, and this diagnosis.
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| Name | Affiliation | Role |
|---|---|---|
| James Hotaling, MS, MS | University of Utah, Division of Urology, Department of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah, Division of Urology | Salt Lake City | Utah | 84132 | United States |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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The patient crosses over at 90 days
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Double-Blind
| Placebo | Drug | A nasal gel with no active ingredients |
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| At Baseline and at the end of the study (Day 180) |
| Comparison of Erection Success Recorded at Baseline and End of Study | Secondary outcomes will include a comparison of answers to question #3 in the Sexual Encounter Profile (SEP): Did the participant's erection last long enough to have successful intercourse? This is a question that will be asked at baseline and at the end of the study. Answers are recorded as Yes or No and Yes is interpreted as a better outcome. | At Baseline and at the end of the study (Day 180) |
| Comparison of Treatment Satisfaction Total Scores at Baseline and End of Study | Secondary outcomes will include a comparison of the total score for the Treatment Satisfaction Questionnaire for Medication (TSQM-9) at baseline and again at the end of the study. The TSQM-9 scale is descriptive in nature and includes the following scales such as:
Higher scores are considered as a better outcome. | At Baseline and at the end of the study (Day 180) |
| Comparison of Erectile Dysfunction Inventory of Treatment Satisfaction Total Scores at Baseline and End of Study | Secondary outcomes will include a comparison of the total score for the Change in Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) at baseline and again at the end of the study. The EDITS scale is descriptive in nature and includes the following scales such as:
Higher scores are considered as a better outcome. | Baseline and at the end of the study (Day 180) |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |