Erectile Dysfunction Classification code 10061461
Conditions
Interventions
Trade Name: MUSE 250 micrograms
Product Name: MUSE 250 micrograms
Pharmaceutical Form: Urethral stick
INN or Proposed INN: ALPROSTADIL
Concentration unit: µg microgram(s)
Concentration type: equal
Con
Sponsors
MEDA AB
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: To be eligible for the study the patient must: 1. be an adult males less than 70 years of age; 2. have had normal erectile function, defined by a pre surgery score on the IIEF erectile function domain of >= 26 prior to surgery; 3. have undergone a bilateral nerve-sparing radical retro pubic prostatectomy for prostate cancer; 4. have post surgery ED, as determined by an IIEF score of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The patient will be excluded who: 1. has a tumor Gleason score equal to or greater than 8 or a prostate specific antigen (PSA) score equal to or greater than 20 ng/ml; 2. requires post surgical radiation therapy or androgen ablation; 3. has a known allergy to alprostadil or any of the components of the formulation or to Viagra or any of the components of the formulation; 4. has used an investigational drug within the past 30 days or previously been enrolled in this study; 5. participated in another trial within the past 6 weeks or currently participates in another trial; 6. requires nitrates, or has a history of cardiac failure or coronary artery disease causing unstable angina or congestive heart failure that has required medical intervention and treatment; 7. has a history of chronic blood pressure less than 90/50 or greater than 170/100 mmHg; 8. is taking alpha blockers as antihypertensive medication; 9. has a concomitant treatment with CYP3A4-inhibitory drugs; 10. has been treated with locally administered Alprostadil (e.g. MUSE) or phosphodiesterase inhibitors (e.g. Viagra) within 30 days before study start or will concomitantly be treated with other locally administered Alprostadil or phosphodiesterase inhibitors besides study medication; 11. has had a stroke, myocardial infarction or life-threatening arrhythmia within the past six months; 12. has hepatic or severe renal failure; 13. has retinitis pigmentosum; 14. has abnormal penile anatomy (stenosis of the distal urethra, severe hypospadia or severe curvature), balanitis, acute or chronic urethritis; 15. has conditions with an increased risk of priapism (sickle cell anaemia or trait, thrombocythmaemia, polycythaemia, multiple myeloma, predisposition to venous thrombosis), or a history of recurrent priapism; 16. has a significant medical problem such as an unstable cardiovascular or cerebrovascular condition which, in the opinion of the investigator, would preclude the administration of study medications, interfere with study evaluations, limit study participation, or otherwise contraindicate sexual activity; 17. has an abnormal ECG that the investigator deems to be clinically significant. The ECG should be maximum three months old.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to evaluate if early introduction of MUSE after nerve-sparing radical prostatectomy (RP) increases erectile function measured by completion of the IIEF questionaire.;Secondary Objective: The secondary objective is to evaluate if early introduction of MUSE after nerve-sparing RP - reduces time to spontaneous erection (taken from diary). The median time from last month diary will be analysed. - affects other diary questions - affects answers in the EDITS questionaires;Primary end point(s): Erectile function measured by completion of the IIEF questionaire. | — |
Countries
Germany, United Kingdom
Outcome results
None listed