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Completed

NCT Number: NCT02798159

Safety and Efficacy of TD0025 (Rocket1h) 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)

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Men Sexual Health Centre; Vietnam- Germany Hospital

Hanoi, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TD0025

Drug

Sildenafil Citrate 50mg

Drug

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

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

    Time frame: Baseline up to 30 days

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

    Time frame: 4 weeks

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

Sponsors and collaborators

Lead sponsor

Vietstar Biomedical Research

Industry

Registry information

Official study 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

Acronym: TD0025

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 14, 2016
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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