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

Erectile Dysfunction Clinical Trial

— TD0025  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02798159
• Other study ID #: TD0025
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 2016
• Est. completion date: July 1, 2018

Study information

• Verified date: June 2016
• Source: Vietstar Biomedical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: July 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• TD0025

• Sildenafil Citrate 50mg

Locations

Country	Name	City	State
Vietnam	Men Sexual Health Centre; Vietnam- Germany Hospital	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Vietstar Biomedical Research

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Orgasmic Function Domain		Baseline, 4 weeks
Secondary	PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Sexual Desire Domain		Baseline, 4 weeks
Secondary	PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain		Baseline, 4 weeks
Secondary	PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Overall Satisfaction Domain		Baseline, 4 weeks
Secondary	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
Secondary	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
Secondary	PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Orgasmic Function Domain		Baseline, 4 weeks
Secondary	PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Sexual Desire Domain		Baseline, 4 weeks
Secondary	PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain		Baseline, 4 weeks
Secondary	PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Overall Satisfaction Domain		Baseline, 4 weeks
Secondary	PART B- PHASE III: Time to Discontinuation of Randomized Treatment		Baseline up to 30 days
Secondary	PART B- PHASE III: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4 Weeks		4 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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