Male Erectile Dysfunction
Conditions
Interventions
Product Name: N/A
Product Code: UK-369,003
Pharmaceutical Form: Tablet
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: UK-369,003
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Pfizer Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Subjects who have given written informed consent to participate in the study. 2. Male subjects 18 to 65 years of age. 3. Documented clinical diagnosis of erectile dysfunction (ED) of at least 6 months duration. ED is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory performance1. There must be documentation (clinical observational and/or anecdotal complaints by the subject) of erectile dysfunction of at least 6 months duration. Original and/or photocopies of the subject’s medical records that provide this documentation must be available for review as source documents. A letter from the treating or referring physician attesting to the fact that the subject has had erectile dysfunction for at least 6 months will be considered sufficient documentation. 4. Subjects who have previously responded successfully to an approved phosphodiesterase Type 5 inhibitor and were treated for a minimum of 2 months at a stable dose and have not experienced a severe or serious treatment related adverse event. The subjects must be willing to discontinue their treatment of the prescribed PDE 5 inhibitor for the duration of the study. 5. Subjects must be in a stable sexual relationship for at least 6 months and willing to attempt sexual intercourse at least once per week on average. 6. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures. Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with hypotension (BP<90/50 mm/hg). 2. Subjects with increased susceptibility to vasodilators including those with left ventricular outflow obstruction (eg, hypertrophic obstructive cardiomyopathy). 3. Subjects in whom sexual activity is inadvisable in the opinion of the investigator (Refer to Recommendations of the Princeton Consensus Panel, 20008 in Appendix 3 of the protocol). 4. Subjects at risk of priapism eg, sickle cell disease, multiple myeloma, myeloproliferative disorders (eg, myeloid leukemia, polycythemia, thrombocythemia). 5. Subject with a history of hypersensitivity to study drug and their excipients or known allergy to PDE5 inhibitors. 6. Subjects who have any medical (including known history of major hematological, renal, vascular, or hepatic abnormalities) or psychological condition or social circumstances that would impair their ability to participate reliably in the study, or those who increase the risk to themselves or others by participating. 7. Subjects with any relevant clinically significant abnormalities on the screening physical examination or laboratory tests (refer to Appendix 1, Appendix 2 and Appendix 3 of the protocol). 8. Subjects who intend to donate blood or blood products during the period of the study or 1 month following completion. 9. Subjects who have received an investigational drug within the last month prior to the screening visit. 10. Subjects who are receiving concomitant treatment with CYP3A4 inhibitors (eg, saquinavir or ketoconazole respectively). 11. Subjects with known hereditary degenerative retinal disorders such as retinitis pigmentosa. 12. Subjects currently treated with alpha-blockers. 13. Subjects who are currently prescribed and/or taking nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or aerosols)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine the efficacy in outpatients with erectile dysfunction of a combination of Immediate Release and Modified Release oral UK-369,003 and PDE5i Cialis taken between 12 and 16 hours prior to sexual activity over a4-week treatment period compared with placebo.;Secondary Objective: To assess the safety and toleration of at least 4 doses of Immediate Release and Modified Release oral UK-369,003 taken asrequired over a 4 week treatment period.;Primary end point(s): The primary endpoint will be the proportion of responders based on successful erections hard enough to attempt sexual intercourse that occur within the time period 12-16 hours post-dose within each treatment group as measured by question 5 in the event log. Question 5 in the subject event log states, “Did you get an erection that was hard enough to attempt sexual intercourse?” and has a dichotomous (yes/no) response. The subject event log will be completed every time the subject takes a dose and the data used to calculate the proportions. | — |
Countries
Germany, Spain, United Kingdom
Outcome results
None listed