Erectile dysfunction
Conditions
Sponsors
Vectura Group plc
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Males aged between 18 and 65 years (inclusive) 2. Stable, heterosexual relationship in which patient and partner are willing to attempt vaginal intercourse at least once per week on average during the study 3. Patient reports having experienced ED for at least 6 months 4. Within the month prior to study Screening at Visit 1, the patient must have experienced an erection, which in the patient’s opinion was considered adequate for sexual intercourse. This can have been achieved spontaneously (e.g. nocturnal, morning) or by any means including pharmacologic 5. Subject 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 the Baseline Visit 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 known history of glucose intolerance as defined by one of the tests below: a. glycosylated haemoglobin (HbA1c) > 8% or b. Fasting plasma glucose (FPG) = 126 mg/dL on two occasions within the last month prior to Screening Visit 1 (Week -6) or c. Random glucose = 200 mg/dL within the last month prior to Screening Visit 1 (Week ?6) 7. Patients with a known propensity to postural hypotension in the previous 12 months 8. Any patient who has a SBP of 700 IU/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. 14. Patient’s with Peyronie’s disease or congenital or trauma deformities of the penis 15. Patients with existing cancer and those in remission for less than 5 years 16. Major psychiatric disorders e.g. schizophrenia, bipolar or other major depressive illness 17. Patients previously diagnosed with Human Immunodeficiency Virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS) 18. Patients with evidence, as ascertained from examination, tests or history, to indicate cardiovascular, gastrointestinal (GI) tract, liver, kidneys, central nervous system (CNS), pulmonary system or bon
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To explore, in patients with ED of varied aetiology and disease severity, the maximum tolerated and minimally effective dose responses of VR004 by examining the efficacy and dose response at three different nominal doses (220 µg, 310 µg and 430 µg). Efficacy will be measured by the co-primary and the secondary efficacy questions.;Secondary Objective: 2. To compare the efficacy of three doses of VR004 with that of placebo 3. To examine the haemodynamic safety and tolerability profile of VR004, at all tested doses, as measured by response to orthostatic challenge and the incidence and severity of spontaneously reported AEs, vital signs, lung function and abnormal laboratory test results 4. To verify the suitability of the Aspirair® inhaler in the treatment of erectile dysfunction during the at home treatment period. The mechanical robustness and the drug delivery performance of the inhaler will be verified in the laboratory by examination and testing of the returned devices at the end of the study.;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. The primary device end-points of this study are: 1. The number of devices showing any signs of unacceptable wear or damage after use 2. The in-vitro drug delivery performance of the devices, as measured by fine particle dose and delivered dose. | — |
Countries
United Kingdom
Outcome results
None listed