Erectile Dysfunction Clinical Trial
Official title:
A Phase 2a, Single-Dose, Double-Blind, Placebo-Controlled, 2-Way Crossover Study to Evaluate the Efficacy and Safety of SST-6006 Compared to Placebo in the Treatment of Erectile Dysfunction
This is a Phase 2a, single-dose, double-blind, placebo-controlled, 2-way crossover study in men with ED. A single 2 gram dose of SST-6006 topical cream 5% w/w (formulated to deliver 100 mg of sildenafil) or a topical placebo cream will be applied to the penile shaft and glans. There are 4 study phases: the Initial Patient Screening Phase (Visit 1, an Off Site 4-Week Run-in Period and Visit 2), the Final Patient Screening Phase (Visit 3), the SST-6006/Placebo Double-Blind Dosing Phase (Visits 4-5), and the Follow-up Phase. Primary outcomes will be be evaluated at Weeks 7 and 8 of the study
Initial Patient Eligibility: Visit 1 (Day 1) After the patient provides written informed
consent, the initial screening procedures will be performed. Patients who meet all
eligibility criteria will be instructed on completion of the SEP Diary, the need for a one
week washout of any ED medications before starting the Off-Site 4-Week Run-In Period and that
the use of any ED medications will be prohibited throughout the entire 4-week duration and up
until the completion of Visit 5. Site staff will contact patients by phone between 4 and 7
days following Visit 1 (on Days 4- 7) to communicate eligibility (met laboratory parameters
and the one week washout) to participate in the Off-Site 4-Week Run-In Period. Site staff
will also schedule the Topical Placebo RigiScan Qualification Visit (Visit 2) to be within
two days of completion of the 4-Week Run-In Period for eligible patients. Ineligible patients
will be instructed to discard their SEP Diary and will be discontinued from further study
participation Off-Site 4-Week Run-In Period (Day 8-35) Eligible patients will participate in
an Off-Site 4-Week Run-In Period during which time they will attempt intercourse a minimum of
4 times. Use of any ED medications will be prohibited throughout the entire 4-week duration
and up until the completion of Visit 5. Patients will be asked to maintain a Sexual Encounter
Profile (SEP) diary during the 4-Week Run-In Period to be completed after each intercourse
attempt.
Topical Placebo RigiScan Qualification: Visit 2 (Day 36 [+ 2 days]) Patients who successfully
complete the 4-Week Run-In will be instructed to complete the IIEF questionnaire at the
beginning of Visit 2. Eligible patients must have documented mild-moderate ED as demonstrated
by a score of 11-21 in the International Index of Erectile Function (IIEF) Erectile Function
domain of the IIEF questionnaire.
Eligible patients will then complete a single-blind (patient) 60 minute plethysmography
procedure using placebo cream to familiarize patients with the plethysmography device (i.e.
RigiScan) and evaluate the placebo response with Visual Sexual Stimulation (VSS).
Patients who demonstrate a topical placebo response (i.e. achieve an erection of ≥ 60%
rigidity at the base of the penis for a cumulative duration of > 4 minutes) will be
ineligible for further study participation. Any patients with an adverse dermatologic
reaction to the placebo cream will be excluded from further participation in the study but
will be followed until normalization of symptoms.
Safety data for all patients, regardless of continued eligibility, will be included in the
database as patients will have been exposed to IP (placebo cream only) during this visit.
There will be a 7 (± 1) day washout period between Visits 2 and 3.
Oral Sildenafil RigiScan Qualification: Visit 3 (Day 43 [± 2 days]) Patients who meet the
eligibility criteria will then complete the Oral Sildenafil RigiScan Qualification visit,
consisting of a single-blind (patient) plethysmography procedure with 60 minutes of VSS to
evaluate the patient's response to oral sildenafil.
Patients who do not respond to oral sildenafil (i.e., do not achieve ≥ 60% rigidity at the
base of the penis for a cumulative duration of >15 minutes and an EHS Score of 3 or 4) will
be excluded from further study participation.
There will be a 7 (± 1) day washout period between Visit 3 and Visit 4 (i.e., the first visit
in the SST-6006/Placebo Double-Blind Dosing Phase).
SST-6006/Placebo Double-Blind Dosing Phase: Visits 4 & 5 (Days 50 and 57 [± 2 days]) Eligible
patients will be randomized to a sequence of dosing (i.e., placebo cream then SST-6006 or
SST-6006 then placebo cream). The SST-6006/Placebo Double-Blind Dosing Phase will consist of
two plethysmography procedures with 60 minutes of VSS. One will evaluate the patient's
response to SST-6006 and the other will evaluate the patient's response to placebo cream.
Patients will be instructed to complete a 4-Point Erection Hardness Scale (EHS) immediately
following completion of the plethysmography procedure at each visit. There will be a 7 (± 1)
day wash-out between Visit 4 and Visit 5.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05366504 -
LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment
|
Phase 2/Phase 3 | |
Recruiting |
NCT02573805 -
the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males
|
N/A | |
Recruiting |
NCT02745808 -
Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
Withdrawn |
NCT02579148 -
Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
Withdrawn |
NCT01967251 -
Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction
|
Phase 2 | |
Recruiting |
NCT02225548 -
Sagene 2014 - Parkinson's Disease and Erectile Dysfunction
|
Phase 4 | |
Completed |
NCT02587988 -
Trial to Evaluate the Efficacy and Safety of HCP1302
|
Phase 3 | |
Completed |
NCT02945462 -
Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED)
|
Phase 1 | |
Completed |
NCT01937871 -
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)
|
Phase 3 | |
Completed |
NCT01698684 -
Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction
|
Phase 4 | |
Not yet recruiting |
NCT01321489 -
A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies
|
Phase 3 | |
Completed |
NCT02226237 -
Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy
|
N/A | |
Completed |
NCT01230541 -
Effect of Udenafil on Spermatogenesis
|
Phase 1 | |
Terminated |
NCT01262833 -
Pudendal Assessment in Erectile Dysfunction
|
N/A | |
Completed |
NCT01037244 -
Treatment of Erectile Dysfunction I
|
Phase 3 | |
Completed |
NCT01037218 -
Treatment of Erectile Dysfunction II
|
Phase 3 | |
Recruiting |
NCT00313898 -
Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males
|
Phase 4 | |
Completed |
NCT00421083 -
Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury
|
Phase 3 | |
Completed |
NCT00663728 -
Assessment of Duration of Erection With Vardenafil 10 mg
|
Phase 4 | |
Completed |
NCT00667979 -
Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse
|
Phase 4 |