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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-07-01

Brief Summary

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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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Detailed Description

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Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

TD0025

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

TD0025

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

TD0025

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

TD0025

Intervention Type DRUG

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

Group Type EXPERIMENTAL

TD0025

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Sildenafil Citrate 50mg

Intervention Type DRUG

Interventions

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TD0025

Intervention Type DRUG

Sildenafil Citrate 50mg

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No