Safety and Efficacy of TD0025 (Rocket1h) for Treatment of Erectile Dysfunction

Vietstar Biomedical Research

Status and phase: Completed; Phase 3; Phase 2

Conditions: Erectile Dysfunction

Treatments: Drug: TD0025; Drug: Sildenafil Citrate 50mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02798159

TD0025

Details and patient eligibility

About

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)

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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168 participants in 6 patient groups

Part A- Arm 1

Experimental group

Description:

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.

Treatment:

Drug: TD0025

Part A- Arm 2

Experimental group

Description:

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.

Treatment:

Drug: TD0025

Part A- Arm 3

Experimental group

Description:

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.

Treatment:

Drug: TD0025

Part A- Arm 4

Experimental group

Description:

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.

Treatment:

Drug: TD0025

Part B- Arm 1

Experimental group

Description:

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

Treatment:

Drug: TD0025

Part B- Arm 2

Active Comparator group

Description:

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

Treatment:

Drug: Sildenafil Citrate 50mg