A Randomized, Placebo Control, Double-blinded, Double-dummy, Phase 2/3 Combination Study to Evaluate the Safety and Efficacy of TD0025 (Rocket1h) Compared With Sildenafil Citrate for Treatment of Erectile Dysfunction
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Vietstar Biomedical Research
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), question # 3 and #4
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
Part A- Arm 1
Investigational dose = 0.25 time of the expected dose. The drug should not be taken more than one time a day or 3 times a week Drug: TD0025 Administered orally once a day, 5 hours before sexual activity, for 1 month.
Intervention: TD0025 (Drug)
Part A- Arm 2
Investigational dose = 0.5 time of the expected dose. The drug should not be taken more than one time a day or 3 times a week Drug: TD0025 Administered orally once a day, 5 hours before sexual activity, for 1 month.
Intervention: TD0025 (Drug)
Part A- Arm 3
Investigational dose = 1 time of the expected dose. The drug should not be taken more than one time a day or 3 times a week Drug: TD0025 Administered orally once a day, 5 hours before sexual activity, for 1 month.
Intervention: TD0025 (Drug)
Part A- Arm 4
Investigational dose = 1.25 time of the expected dose. The drug should not be taken more than one time a day or 3 times a week Drug: TD0025 Administered orally once a day, 5 hours before sexual activity, for 1 month.
Intervention: TD0025 (Drug)
Part B- Arm 1
Investigational dose = optimal dose in Part A. The drug should not be taken more than one time a day or 3 times a week.
Drug: TD0025 Administered orally once a day, 5 hours before sexual activity, for 1 month
Intervention: TD0025 (Drug)
Part B- Arm 2
Sildenafil Citrate 50 mg on demand The drug should not be taken more than one time a day or 3 times a week. Administered orally once a day, 1 hour before sexual activity, for 1 month
Intervention: Sildenafil Citrate 50mg (Drug)
Outcomes
Primary Outcomes
PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), question # 3 and #4
Time Frame: 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
Time Frame: Baseline, 4 weeks
Secondary Outcomes
- 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 A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Orgasmic Function 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: 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 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: Time to Discontinuation of Randomized Treatment(Baseline up to 30 days)
- 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), Intercourse Satisfaction Domain(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 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: 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: 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: 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 Self Esteem Domain of the Self-Esteem and Relationship (SEAR) Questionnaire(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)