A New Sildenafil Oral Film in Patients With Erectile Dysfunction
Study Details
Study Description
Brief Summary
This is a Phase III, prospective, interventional, multi-center, randomized, double-blind, fixed-dose, placebo-controlled, parallel group clinical study required by FDA to demonstrate the efficacy and safety of Sildenafil oral film 50 mg, 75 mg and 100 mg as compared to placebo in approximately 600 men clinically diagnosed with erectile dysfunction (ED).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The study will consist of Screening & Pre-treatment phase (Visit 0 followed by 4 weeks without treatment for the subjects who met eligibility criteria at screening phase) and Double-blind Treatment Phase comprising a 12-week treatment period for the subjects who were compliant in pre-treatment phase (Visits 1, 2, 3 and 4).
The target population for this study is men with ED, including 30-35% of geriatric ED subjects. During the treatment period, subjects will be instructed to take 1 dose of Sildenafil oral film or Placebo approximately 60 minutes prior to initiation of sexual activity. The study foresees a fixed-dose regimen and no change in the assigned dosage can be made during the study. Study medication can be taken without water and in addition with or without food and no restrictions will be placed on the timing for consumption of food (details regarding type and time of food and alcohol intake will be collected).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Placebo oral film, on-demand use once per day, at maximum 60 films during a 12-week period |
Drug: Placebo
Placebo Oral Film
Other Names:
|
| Experimental: Sildenafil 50 mg Sildenafil 50 mg oral film, on-demand use once per day, at maximum 60 films during a 12-week period |
Drug: Sildenafil Oral Film 50 mg
Sildenafil Oral Film containing 50 mg sildenafil as citrate
Other Names:
|
| Experimental: Sildenafil 75 mg Sildenafil 75 mg oral film, on-demand use once per day, at maximum 60 films during a 12-week period |
Drug: Sildenafil Oral Film 75 mg
Sildenafil Oral Film containing 75 mg sildenafil as citrate
Other Names:
|
| Experimental: Sildenafil 100 mg Sildenafil 100 mg oral film, on-demand use once per day, at maximum 60 films during a 12-week period |
Drug: Sildenafil Oral Film 100 mg
Sildenafil Oral Film containing 100 mg sildenafil as citrate
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Safety of Sildenafil doses versus placebo [12 weeks of treatment]
Safety of Sildenafil doses versus placebo, i.e., the proportion of subjects with at least one Treatment Emergent Adverse Events (TEAEs) of Special Interest ("Headache" or "Dizziness")
- Efficacy of Sildenafil 50 mg doses versus placebo - IIEF-EF [Baseline to the end of the 12-week treatment period]
Efficacy of Sildenafil 50 mg versus placebo evaluated using co-primary efficacy endpoint from the change in Erectile Function (EF) domain of the International Index for Erectile Function (IIEF) questionnaire
- Efficacy of Sildenafil 75 mg doses versus placebo - IIEF-EF [Baseline to the end of the 12-week treatment period]
Efficacy of Sildenafil 75 mg versus placebo evaluated using co-primary efficacy endpoint from the change in Erectile Function (EF) domain of the International Index for Erectile Function (IIEF) questionnaire
- Efficacy of Sildenafil 100 mg doses versus placebo - IIEF-EF [Baseline to the end of the 12-week treatment period]
Efficacy of Sildenafil 100 mg versus placebo evaluated using co-primary efficacy endpoint from the change in Erectile Function (EF) domain of the International Index for Erectile Function (IIEF) questionnaire
- Efficacy of Sildenafil 50 mg doses versus placebo - SEP Question 2 [Between the 4-week pre-treatment period and the end of the 12-week treatment period]
Efficacy of Sildenafil 50 mg versus placebo evaluated using co-primary efficacy endpoint from the change in percentage of "yes" responses to Sexual Encounter Profile (SEP) Question 2
- Efficacy of Sildenafil 75 mg doses versus placebo - SEP Question 2 [Between the 4-week pre-treatment period and the end of the 12-week treatment period]
Efficacy of Sildenafil 75 mg versus placebo evaluated using co-primary efficacy endpoint from the change in percentage of "yes" responses to Sexual Encounter Profile (SEP) Question 2
- Efficacy of Sildenafil 100 mg doses versus placebo - SEP Question 2 [Between the 4-week pre-treatment period and the end of the 12-week treatment period]
Efficacy of Sildenafil 100 mg versus placebo evaluated using co-primary efficacy endpoint from the change in percentage of "yes" responses to Sexual Encounter Profile (SEP) Question 2
- Efficacy of Sildenafil 50 mg doses versus placebo - SEP Question 3 [Between the 4-week pre-treatment period and the end of the 12-week treatment period]
Efficacy of Sildenafil 50 mg versus placebo evaluated using co-primary efficacy endpoint from the change in percentage of "yes" responses to SEP Question 3
- Efficacy of Sildenafil 75 mg doses versus placebo - SEP Question 3 [Between the 4-week pre-treatment period and the end of the 12-week treatment period]
Efficacy of Sildenafil 75 mg versus placebo evaluated using co-primary efficacy endpoint from the change in percentage of "yes" responses to SEP Question 3
- Efficacy of Sildenafil 100 mg doses versus placebo - SEP Question 3 [Between the 4-week pre-treatment period and the end of the 12-week treatment period]
Efficacy of Sildenafil 100 mg versus placebo evaluated using co-primary efficacy endpoint from the change in percentage of "yes" responses to SEP Question 3
Secondary Outcome Measures
- Safety TEAE of special interest - headache [Over 12 weeks of treatment as compared to placebo]
The incidence of TEAEs of Special Interest of headache
- Safety TEAE of special interest - dizziness [Over 12 weeks of treatment as compared to placebo]
The incidence of TEAEs of Special Interest of dizziness
- Safety TEAE of vasomotor drug effects [Over 12 weeks of treatment as compared to placebo;]
The incidence of TEAEs that may be suggestive of vasomotor drug effects and the proportion of subjects with at least one of these TEAEs
Other Outcome Measures
- Exploratory efficacy of Sildenafil oral film compared to placebo - attempts [Up to 12 weeks of treatment]
Number of attempts for sexual intercourse
- Exploratory efficacy of Sildenafil oral film compared to placebo - overall treatment satisfaction [Up to 12 weeks of treatment]
Mean treatment satisfaction as assessed by Overall Treatment Satisfaction score on a 5-point scale (4=excellent; 3=good; 2=fair; 1=poor; 0=none)
- Exploratory efficacy of Sildenafil oral film compared to placebo - GAQ [Up to 12 weeks of treatment]
Proportion of subject responses to Global Assessment Questionnaire (GAQ) consisting of 2 questions (Yes or No): Question 1 'Has the treatment you have been taking improved your erectile function?' and if necessary, Question 2 'If yes, has the treatment improved your ability to engage in sexual activity?'.
- Exploratory efficacy of Sildenafil oral film compared to placebo - drug product palatability [Up to 12 weeks of treatment]
Subjective measures of the Drug Product Palatability consisting of 5 specific questions: "1. Rate the oral sensation/mouthfeel of the drug product"; "2. Rate the taste of the drug product"; "3. How strong is the taste?"; "4. Rate the aftertaste of the drug product"; and "5. How strong is the aftertaste?". For questions 1, 2, and 4, the range of responses is: "very unpleasant, unpleasant, no sensation/mouthfeel, pleasant, very pleasant." For questions 3 and 5, the range of responses is: "very strong, strong, moderate, mild, no taste".
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Heterosexual male subjects aged ≥18 years;
-
Confirmed clinical diagnosis of ED for at least 6 months;
-
Involved in a continuous sexual relationship with their partner for at least 3 months.
Exclusion Criteria:
-
Currently suffering from any oromucosal condition or recent oral surgery that could interfere with the study drug;
-
Any significant cardiovascular abnormality;
-
Patients > 65 years with any degree of hepatic impairment or severe renal impairment or any significant pulmonary, gastrointestinal, hematological, endocrinal, metabolic or neurological disorder;
-
Patients < 65 years with severe hepatic impairment;
-
Any presence of chronic indwelling urethral catheterization or penile anatomical abnormalities that would significantly impair EF;
-
Any history of Peyronie's disease; or who have conditions which may predispose them to priapism;
-
Any history or comorbidity of hypoactive sexual desire disorder, premature ejaculation or other ejaculatory disorders or radical prostatectomy;
-
Any history of severe/uncontrolled diabetes;
-
Hypersensitivity to Sildenafil or to any of the excipients of the oral film, or idiosyncratic reactions to other PDE5 inhibitors;
-
Any history of migraine;
-
Any history of unresponsiveness to PDE5 inhibitor treatment or significant side-effects with PDE5 inhibitor;
-
Subjects with or with history of severe vision impairment, temporary visual disturbances (blurred vision, increased light sensitivity and color change), retinitis pigmentosa, Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) or any optic neuropathy;
-
During the course of the study, subjects are not allowed to take any prescription, over-the-counter, herbal, or naturopathic products for "male enhancement" or the treatment of ED (including testosterone administration);
-
During the course of the study, subjects are not allowed to take any form of nitric oxide donors such as organic nitrates or organic nitrites either regularly and/or intermittently, and guanylate cyclase (GC) stimulators;
-
Patients must be stable on therapy with Alpha-blockers or Amlodipine at inclusion and already taking a PDE5 inhibitor without any safety concern prior to initiating the study (i.e., no history of significant side-effects with co-administration of PDE5 inhibitors);
-
Subjects known to abuse alcohol or drugs that could interfere with the patient's safety or study compliance
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- IBSA Institut Biochimique SA
Investigators
- Study Director: Giuseppe Mautone, IBSA Head of R&D Scientific Affairs
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20US-SDF15