Premature ejaculation
Conditions
Interventions
Product Name: Clomipramine hydrochloride
Product Code: VR776
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Clomipramine hydrochloride
CAS Number: 17321-77-6
Current Sponsor code: VR776
C
Sponsors
Vectura Group plc
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male; 2. Aged 18 to 65 years inclusive; 3. Weight between 60kg and 130kg inclusive; 4. Documented history of primary premature ejaculation; 5. Willing to restrict alcohol consumption to a maximum of 2 units for 8 hours before each dose of study medication. In addition patients should not consume more than 21 units per week for the duration of the study; 6. Willing not to drive or operate machinery for 6 hours following dosing; 7. In a stable, monogamous heterosexual relationship for at least 6 months; 8. Adequate erectile function for vaginal penetration; 9. Documented self estimated IVELT of of less than or equal to 3 minutes at screening; 10. Willing to attempt intercourse on at least 3 occasions and no more than 5 occasions during the run in period and during each treatment period; 11. Have a confirmed mean IVELT of of less than or equal to 2 minutes during the run in period; 12. Sexual partner able and willing to use a stopwatch to fulfil the study requirements; 13. Able to read, comprehend, and write English at a sufficient level to understand and complete study related materials; 14. Patient willing to refrain from any (non-study) pharmacological intervention, behavioural or other technique to delay ejaculation during intercourse during the study; 15. Patient and partner give written, fully 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. History of clinically significant allergies; 2. Treatment in the last 6 months for depression, psychiatric disorders, mood disorders, schizophrenia, substance abuse or anxiety disorders; 3. Current treatment or treatment within the previous 4 weeks with SSRIs, tricyclic anti-depressants or mono-amine oxidase inhibitors; 4. History of surgery on their reproductive organs considered likely to affect sexual dysfunction (e.g. penile implant, prostate surgery). Patients who have had a vasectomy and/or who have been circumcised will be permitted; 5. Treatment for premature ejaculation e.g. local anaesthetic products, or intra-cavernosal injection in the four weeks prior to screening. The use of condoms will be permitted provided their use (including specific type / brand) continues unchanged for the duration of the study; 6. Patients with a history of other clinically significant organic diseases e.g. uncontrolled hypertension, ischemic heart disease, aortic aneurysm, uncontrolled hyperthyroidism, uncontrolled diabetes, uncontrolled asthma or other significant lung disease; 7. History of myocardial infarction in the previous 3 months or history of angina; 8. History of glaucoma, pyloric stenosis to the bladder or history of benign prostatic hypertrophy; 9. FEV1 less than 80% of predicted; 10. History of intolerance to tricyclic antidepressants; 11. Current treatment with any drug known to interact with clomipramine including MAOIs, carbamazepine, phenytoin, neuroleptics, barbiturates, anticholinergics, sympathomimetics, cimetidine, quinindine, antihypertensives and thyroid treatments; 12. Participation in a study with a new molecular entity during the previous 4 months or any other clinical trial during the previous 3 months; 13. Partner unwilling to give informed consent or unable to operate a stop–watch; 14. Any evidence to suggest the patient will be unable to use the Aspirair inhaler correctly; 15. Those, who, in the opinion of the investigator, have a risk of non-compliance with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To measure the effectiveness, compared to placebo, of 1 mg and 2 mg doses of VR776 administered via the Aspirair inhaler on the IVELT (intravaginal ejaculatory latency time) measured by stopwatch and recorded by the partner during sexual intercourse.;Secondary Objective: To assess the safety and tolerability of single and as required use of repeat inhaled doses of VR776 in healthy male patients with premature ejaculation. To assess the patients’ satisfaction and control of ejaculation during treatment with 1 mg and 2 mg doses of VR776 administered via the Aspirair inhaler compared to placebo. ;Primary end point(s): The primary efficacy parameter is IVELT (intravaginal ejaculatory latency time) as measured by the partner using a stopwatch. | — |
Countries
United Kingdom
Outcome results
None listed