Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-06 @ 9:41 AM
Study NCT ID:
NCT02390960
Status:
COMPLETED
Last Update Posted:
2017-10-12
First Post:
2015-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2a Topical Sildenafil Proof-of-Concept Study in Men With Mild to Moderate ED
Sponsor:
Strategic Science & Technologies, LLC
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: