Clinical trial NCT02798159: Safety and Efficacy of TD0025 (Rocket1h) for Treatment of Erectile Dysfunction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Erectile Dysfunction
Keywords: Sexual Dysfunction
Physiological Sexual Dysfunctions
Psychological Sexual and Gender Disorders
Sildenafil
Lead sponsor: Vietstar Biomedical Research
Sponsor class: INDUSTRY
First posted: 2016-06-14
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), question # 3 and #4
timeFrame: Baseline, 4 weeks
measure: PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Erectile Function (EF) Domain
timeFrame: Baseline, 4 weeks
measure: PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Orgasmic Function Domain
timeFrame: Baseline, 4 weeks
measure: PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Sexual Desire Domain
timeFrame: Baseline, 4 weeks
measure: PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain
timeFrame: Baseline, 4 weeks
measure: PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Overall Satisfaction Domain
timeFrame: Baseline, 4 weeks
measure: 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
timeFrame: Baseline, 4 weeks
measure: PART A- PHASE II: The percentage of patients with abnormal hematology and biochemistry laboratory values at baseline and after 4 weeks of treatment
timeFrame: Baseline, 4 weeks
measure: PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Orgasmic Function Domain
timeFrame: Baseline, 4 weeks
measure: PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Sexual Desire Domain
timeFrame: Baseline, 4 weeks
measure: PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain
timeFrame: Baseline, 4 weeks
measure: PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Overall Satisfaction Domain
timeFrame: Baseline, 4 weeks
measure: PART B- PHASE III: Time to Discontinuation of Randomized Treatment
timeFrame: Baseline up to 30 days
measure: PART B- PHASE III: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4 Weeks
timeFrame: 4 weeks
measure: PART B- PHASE III: Change From Baseline to 4 Weeks of the Sexual Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire
timeFrame: Baseline, 4 weeks
measure: PART B- PHASE III: Change From Baseline to 4 Weeks of the Confidence Domain of the Self-Esteem and Relationship (SEAR) Questionnaire
timeFrame: Baseline, 4 weeks
measure: PART B- PHASE III: Change From Baseline to 4 Weeks of the Self Esteem Domain of the Self-Esteem and Relationship (SEAR) Questionnaire
timeFrame: Baseline, 4 weeks
measure: PART B- PHASE III: Change From Baseline to 4 Weeks of the Overall Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire
timeFrame: Baseline, 4 weeks
measure: 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
timeFrame: Baseline, 4 weeks
measure: PART B- PHASE III: The percentage of patients with abnormal hematology and biochemistry laboratory values at baseline and after 4 weeks of treatment
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Men Sexual Health Centre; Vietnam- Germany Hospital
Study officials:
affiliation: Men Sexual Health Centre, Vietnam- Germany Hospital
name: Nguyen Quang, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References: