Safety and Efficacy of TD0025 (Rocket1h) for Treatment of Erectile Dysfunction
Phase 2
Completed
- Conditions
- Erectile Dysfunction
- Interventions
- Registration Number
- NCT02798159
- Lead Sponsor
- Vietstar Biomedical Research
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 168
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A- Arm 2 TD0025 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. Part A- Arm 4 TD0025 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. Part B- Arm 2 Sildenafil Citrate 50mg 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 Part A- Arm 3 TD0025 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. Part A- Arm 1 TD0025 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. Part B- Arm 1 TD0025 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which TD0025 (Rocket1h) treats erectile dysfunction compared to PDE5 inhibitors like sildenafil?
How does the efficacy of TD0025 compare to standard-of-care phosphodiesterase type 5 inhibitors in ED patients?
Are there specific biomarkers that can predict patient response to TD0025 in treating erectile dysfunction?
What are the potential adverse events associated with TD0025 and how do they compare to sildenafil in ED trials?
What other compounds or combination therapies are being developed by Vietstar Biomedical Research for erectile dysfunction treatment?
Trial Locations
- Locations (1)
Men Sexual Health Centre; Vietnam- Germany Hospital
🇻🇳Hanoi, Vietnam
Men Sexual Health Centre; Vietnam- Germany Hospital🇻🇳Hanoi, Vietnam