erectile dysfunction Classification code 10052003
Conditions
Sponsors
vectura group plc
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Males aged between 18 and 65 years inclusively 2. Stable heterosexual relationship in which patient and partner are willing to attempt vaginal intercourse at least once per week on average during the trial 3. Patient reports having experienced ED for at least 6 months 4. Must have, in the month prior to Screening Visit 1 (Week -6), experienced an erection, which in the patient’s opinion was considered adequate for sexual intercourse, spontaneously (e.g. nocturnal, morning) or by any means including pharmacologic or device intervention 5. Patient willing and able to comply with study procedures 6. Patient will provide voluntary written informed consent. Are the trial subjects under 18? no 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with clinically significant blood test abnormalities and previous medical history/intercurrent illnesses, which may compromise the safety of the patient in the study 2. Patients recording an IIEF Erectile Function Domain (questions 1 – 5 and 15) score = 26 at Baseline 3. Patients with compromised lung function as indicated by an FEV1 value = 80% predicted value or patients with a documented history of asthma or chronic obstructive pulmonary disease (COPD) 4. Significant organic disease that may adversely affect sexual function, such as radical prostatectomy, pelvic surgery, vascular or neurological disease such as multiple sclerosis (MS) or spinal cord injury 5. Myocardial infarction or stroke in the 12 months prior to screening, unstable angina or other cardiovascular condition where, in the Investigator’s opinion, sexual intercourse is contra indicated 6. Patients with uncontrolled diabetes as defined by: a. A known diabetic, not under any form of medical management, i.e. no therapeutic lifestyle (diet, exercise) changes; not on oral hypoglycaemics nor on insulin or b. HbA1c > 8% or c. Fasting plasma glucose (FPG) greater than or equal to 126 mg/dL on two occasions within the last month prior to Screening Visit 1 (Week -6) or d. Random glucose = 200 mg/dL within the last month prior to Screening Visit 1 (Week -6) 7. Patients with a recorded history of postural hypotension in the previous 12 months and any patient who has a SBP of 700 mIU/L) or abnormal Total testosterone (normal range 7.35 – 60.1 nmol/L) and free testosterone levels - normal ranges: Age (Years) Normal Range Units 20 to 39 8.8 – 27.0 pg/mL 40 to 59 7.2 – 23.0 pg/mL 60 to 80 5.6 – 19.0 pg/mL If there is a discrepancy between Total and free testosterone (i.e. one normal and the other low) then the result of the free testosterone should determine the patient's eligibility. 13. Patient’s with Peyronie’s disease or congenital or trauma deformities of the penis 14. Patients with existing cancer and those in remission for less than 5 years 15. Major psychiatric disorders e.g. schizophrenia, bipolar or other major depressive illness 16. Patients previously diagnosed with human immunodeficiency virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS) 17. Patients with evidence as ascertained from examination, tests or history to indicate cardiovascular, gastroi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the efficacy of Inhaled VR004 in Patients with Erectile Dysfunction;Secondary Objective: ;Primary end point(s): The primary end-points of this study are the change in the proportion of “yes” answers from Baseline to the last 4 weeks of study treatment in: 1. The Sexual Encounter Profile (SEP) question number 2 measuring the ability to achieve vaginal penetration 2. The SEP question number 3 measuring the ability to maintain an erection long enough for successful intercourse in patients with ED. | — |
Countries
United Kingdom
Outcome results
None listed