A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses
Status and phase
Completed
Phase 2
Conditions
Impotence
Treatments
Drug: PF-00592379
Drug: Sildenafil 100mg
Details and patient eligibility
About
The primary aim of this study is to assess how effective PF-00592379 is in restoring penile erections in patients with erectile dysfunction. Patients will attend for 4 treatment visits where they will receive the following in random order; 2 separate doses of PF-00592379, sildenafil 100mg used as a positive control, or placebo (dummy medication). The effect on penile erections will be assessed in the clinic using penile plethysmography (RigiScan PlusTM technique).
Sex
Male
Ages
18 to 65 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Erectile dysfunction, previous good response to an oral treatment for erectile dysfunction.
Exclusion criteria
- Patients with high blood pressure or certain heart conditions (e.g. angina, heart failure), regardless of whether treated or not.
- Patients on nitrates or alpha-blocker medications.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Double Blind
Trial contacts and locations
2
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Data sourced from clinicaltrials.gov
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