Safety and Efficacy of TD0025 (Rocket1h) for Treatment of Erectile Dysfunction (TD0025)
Erectile Dysfunction
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Sexual and Gender Disorders, Sildenafil
Eligibility 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
Sites / Locations
- Men Sexual Health Centre; Vietnam- Germany Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Part A- Arm 1
Part A- Arm 2
Part A- Arm 3
Part A- Arm 4
Part B- Arm 1
Part B- Arm 2
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.
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.
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.
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.
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
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