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

October 9, 2018 updated by: Vietstar Biomedical Research

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam
        • Men Sexual Health Centre; Vietnam- Germany Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A- Arm 1
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.
Drug: TD0025
Experimental: Part A- Arm 2
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.
Drug: TD0025
Experimental: Part A- Arm 3
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.
Drug: TD0025
Experimental: Part A- Arm 4
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.
Drug: TD0025
Experimental: Part B- Arm 1

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
Drug: TD0025
Active Comparator: Part B- Arm 2
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
Drug: Sildenafil Citrate 50mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Baseline, 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
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
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
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
Baseline, 4 weeks
PART B- PHASE III: Time to Discontinuation of Randomized Treatment
Time Frame: Baseline up to 30 days
Baseline up to 30 days
PART B- PHASE III: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4 Weeks
Time Frame: 4 weeks
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
Baseline, 4 weeks
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
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
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
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
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
Baseline, 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vietstar Biomedical Research

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

June 4, 2016

First Submitted That Met QC Criteria

June 8, 2016

First Posted (Estimate)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TD0025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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