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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02798159
• Date of registration: 04/06/2016
• Prospective Registration: No
• Primary sponsor: Vietstar Biomedical Research
• Public title: Safety and Efficacy of TD0025 (Rocket1h) for Treatment of Erectile Dysfunction TD0025
• Scientific title: 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
• Date of first enrolment: May 2016
• Target sample size: 168
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02798159
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

Vietnam

Contacts

• Name: Nguyen Quang, MD. PhD.
• Affiliation: Men Sexual Health Centre, Vietnam- Germany Hospital

Key inclusion & 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Erectile Dysfunction

Intervention(s)

Drug: Sildenafil Citrate 50mg

Drug: TD0025

Primary Outcome(s)

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 Outcome(s)

PART B- PHASE III: Change From Baseline to 4 Weeks of the Confidence Domain of the Self-Esteem and Relationship (SEAR) Questionnaire [Time Frame: Baseline, 4 weeks]

PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Overall Satisfaction Domain [Time Frame: 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 [Time Frame: Baseline, 4 weeks]

PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Orgasmic Function Domain [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: Baseline, 4 weeks]

PART B- PHASE III: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4 Weeks [Time Frame: 4 weeks]

PART B- PHASE III: Time to Discontinuation of Randomized Treatment [Time Frame: Baseline up to 30 days]

PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Erectile Function (EF) Domain [Time Frame: Baseline, 4 weeks]

PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain [Time Frame: Baseline, 4 weeks]

PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain [Time Frame: Baseline, 4 weeks]

PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Orgasmic Function Domain [Time Frame: Baseline, 4 weeks]

PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Sexual Desire Domain [Time Frame: Baseline, 4 weeks]

PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Overall Satisfaction Domain [Time Frame: 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 [Time Frame: Baseline, 4 weeks]

PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Sexual Desire Domain [Time Frame: 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 [Time Frame: Baseline, 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 [Time Frame: Baseline, 4 weeks]

Secondary ID(s)

TD0025

Source(s) of Monetary Support

Please refer to primary and secondary sponsors