Erectile Dysfunction
Conditions
Keywords
Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Sexual and Gender Disorders, Sildenafil
Brief summary
The purpose of this study is to identify the optimal dose(s) of TD0025 for treatment of erectile dysfunction (phase II) and to investigate if treatment of erectile dysfunction with the optimal dose of TD0025 taken as needed over one month is non-inferior than Sildenafil Citrate taken as needed over one month (phase III)
Interventions
DRUGTD0025
DRUGSildenafil Citrate 50mg
Sponsors
Vietstar Biomedical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * History of Erectile Dysfunction (ED) of at least 1 month duration. * Anticipate having the same adult female sexual partner during the study. * Agree not to use any other treatment for ED and to participate in recording responses to questionnaires and other instruments used in this study. * Sign the informed consent form Main
Exclusion criteria
* ED caused by other primary sexual disorders, history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection, or history of penile implant or clinically significant penile deformity * ED caused by untreated or inadequately treated endocrine disease * Current treatment with doxazocin, nitrates, cancer chemotherapy, or anti-androgens * Severe renal or hepatic impairment, history of malignant hypertension * Presence or history of specific heart conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), question # 3 and #4 | Baseline, 4 weeks |
| PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain | Baseline, 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Sexual Desire Domain | Baseline, 4 weeks |
| PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain | Baseline, 4 weeks |
| PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Overall Satisfaction Domain | Baseline, 4 weeks |
| PART A- PHASE II: The percentage of patients with abnormal Testosterone, FSH, LH and Androgen Serum Levels at Baseline and after 4 weeks of treatment | Baseline, 4 weeks |
| PART A- PHASE II: The percentage of patients with abnormal hematology and biochemistry laboratory values at baseline and after 4 weeks of treatment | Baseline, 4 weeks |
| PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Orgasmic Function Domain | Baseline, 4 weeks |
| PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Sexual Desire Domain | Baseline, 4 weeks |
| PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain | Baseline, 4 weeks |
| PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Erectile Function (EF) Domain | Baseline, 4 weeks |
| PART B- PHASE III: Time to Discontinuation of Randomized Treatment | Baseline up to 30 days |
| PART B- PHASE III: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4 Weeks | 4 weeks |
| PART B- PHASE III: Change From Baseline to 4 Weeks of the Sexual Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire | Baseline, 4 weeks |
| PART B- PHASE III: Change From Baseline to 4 Weeks of the Confidence Domain of the Self-Esteem and Relationship (SEAR) Questionnaire | Baseline, 4 weeks |
| PART B- PHASE III: Change From Baseline to 4 Weeks of the Self Esteem Domain of the Self-Esteem and Relationship (SEAR) Questionnaire | Baseline, 4 weeks |
| PART B- PHASE III: Change From Baseline to 4 Weeks of the Overall Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire | Baseline, 4 weeks |
| PART B- PHASE III: The percentage of patients with abnormal Testosterone, FSH, LH and Androgen Serum Levels at Baseline and after 4 weeks of treatment | Baseline, 4 weeks |
| PART B- PHASE III: The percentage of patients with abnormal hematology and biochemistry laboratory values at baseline and after 4 weeks of treatment | Baseline, 4 weeks |
| PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Overall Satisfaction Domain | Baseline, 4 weeks |
| PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Orgasmic Function Domain | Baseline, 4 weeks |
Countries
Vietnam
Outcome results
None listed