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

NCT02798159 | Completed Phase 2

• 1 other identifier: TD0025
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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)

Conditions

Erectile Dysfunction

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (19)

• 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

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

  Baseline, 4 weeks

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

  Baseline, 4 weeks

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

  Baseline, 4 weeks

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

  Baseline, 4 weeks

Study Arms (6)

Part A- Arm 1

EXPERIMENTAL

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

Part A- Arm 2

EXPERIMENTAL

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

Part A- Arm 3

EXPERIMENTAL

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

Part A- Arm 4

EXPERIMENTAL

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

Part B- Arm 1

EXPERIMENTAL

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

Part B- Arm 2

ACTIVE COMPARATOR

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

Interventions

TD0025 DRUG

Part A- Arm 1; Part A- Arm 2; Part A- Arm 3; Part A- Arm 4; Part B- Arm 1

Sildenafil Citrate 50mg DRUG

Part B- Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vietstar Biomedical Research: lead

Study Sites (1)

Men Sexual Health Centre; Vietnam- Germany Hospital

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Erectile Dysfunction; Sexual Dysfunction, Physiological

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Nguyen Quang, MD. PhD.

  Men Sexual Health Centre, Vietnam- Germany Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2016
• First Posted: June 14, 2016
• Study Start: May 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 11, 2018

Record last verified: 2016-06

Locations

VN (1)