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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Nasal Gel used for 90 days then crossed over to placebo gel
A nasal gel with no active ingredients
University of Utah, Division of Urology
Salt Lake City, Utah, United States
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.
Time frame: At Baseline and at the end of the study (Day 180)
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.
Time frame: 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.
Time frame: 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: 1. Very satisfied 2. Somewhat satisfied 3. Neither satisfied nor dissatisfied 4. Somewhat dissatisfied 5. Very dissatisfied Higher scores are considered as a better outcome.
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Time frame: 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: 1. Very satisfied 2. Somewhat satisfied 3. Neither satisfied nor dissatisfied 4. Somewhat dissatisfied 5. Very dissatisfied Higher scores are considered as a better outcome.
Time frame: Baseline and at the end of the study (Day 180)