Trial | NCT02798159  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    sildenafil ...

  • Study Participants

    168
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 Started
May 31
2016
Primary Completion
Mar 01
2018
Study Completion
Jul 01
2018
Last Update
Oct 11
2018

Drug TD0025

Drug Sildenafil Citrate 50mg

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.

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.

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.

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.

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

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

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
No Results Posted