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

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Phase 2

Locations

Vietnam

Study Type

Interventional

Intervention

TD0025

Sildenafil Citrate 50mg

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

Part A- Arm 1

Part A- Arm 2

Part A- Arm 3

Part A- Arm 4

Part B- Arm 1

Part B- Arm 2

Arm 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.

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

Outcomes

Primary Outcome Measures

PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), question # 3 and #4

PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain

Secondary Outcome Measures

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

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

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

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

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

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

PART A- PHASE II: The percentage of patients with abnormal hematology and biochemistry laboratory values at baseline and after 4 weeks of treatment

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

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

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

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

PART B- PHASE III: Time to Discontinuation of Randomized Treatment

PART B- PHASE III: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 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

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

PART B- PHASE III: Change From Baseline to 4 Weeks of the Self Esteem Domain of the Self-Esteem and Relationship (SEAR) Questionnaire

PART B- PHASE III: Change From Baseline to 4 Weeks of the Overall Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire

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

PART B- PHASE III: The percentage of patients with abnormal hematology and biochemistry laboratory values at baseline and after 4 weeks of treatment

Full Information

NCT ID

NCT02798159

First Posted

June 4, 2016

Last Updated

October 9, 2018

Sponsor

Vietstar Biomedical Research

1. Study Identification

Unique Protocol Identification Number

NCT02798159

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

May 2016 (Actual)

Primary Completion Date

March 1, 2018 (Actual)

Study Completion Date

July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vietstar Biomedical Research

4. Oversight

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

Keywords

Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Sexual and Gender Disorders, Sildenafil

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

168 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A- Arm 1

Arm Type

Experimental

Arm Description

Arm Title

Part A- Arm 2

Arm Type

Experimental

Arm Description

Arm Title

Part A- Arm 3

Arm Type

Experimental

Arm Description

Arm Title

Part A- Arm 4

Arm Type

Experimental

Arm Description

Arm Title

Part B- Arm 1

Arm Type

Experimental

Arm Description

Arm Title

Part B- Arm 2

Arm Type

Active Comparator

Arm 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

Intervention Type

Drug

Intervention Name(s)

TD0025

Intervention Type

Drug

Intervention Name(s)

Sildenafil Citrate 50mg

Primary Outcome Measure Information:

Title

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

Title

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 Measure Information:

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

PART B- PHASE III: Time to Discontinuation of Randomized Treatment

Time Frame

Baseline up to 30 days

Title

PART B- PHASE III: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4 Weeks

Time Frame

4 weeks

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nguyen Quang, MD. PhD.

Organizational Affiliation

Men Sexual Health Centre, Vietnam- Germany Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Men Sexual Health Centre; Vietnam- Germany Hospital

City

Hanoi

Country

Vietnam

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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