None listed
Conditions
Interventions
Group 1 Type of group
The initial dose for the study will be 40 mg orally of fentolamin, with the option of increasing it to 80 mg if the doses of the patients do not report any categorical clinical improvement with the 40 mg dose. No other dose level will be allowed.
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: To qualify for this study, male patients 18 years of age or older must: • Provide written informed consent • Have a history of erectile dysfunction (defined as a consistent change in the quality of erection that adversely affects the patient´s satisfaction with the sexual relationship) for at least 6 months • Having a female sexual partner and monogamous with which the patient has a stable relationship (vaginal penetration is one of the requirements) • Have a sum of the scores of the questions from the IIEF 1, 2, 3, 4, 5 and 15 equal to 13 to 24, inclusive.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions or who meet any of the following criteria will be excluded from the study. • Impotence caused by an untreated endocrine disorder, for example, hypopituitarism, hypothyroidism or hypogonadism • History of radical prostatectomy, spinal cord damage or penile damage • Significant penile curvature • Clinical history of significant liver disorder (defined as SGOT or SGPT> 3 times UNL in the last 6 months), renal disorder (defined as serum creatinine> 2.5 mg% in the last 6 months) • Uncontrolled symptomatic cardiovascular disorder that could include coronary artery disease, that is, angina pectoris or malignant cardiac conditions, congestive heart failure, uncontrolled arrhythmias, significant conduction defects, implanted defibrillators or pacemakers, myocardial infarction, effusions and / or cardiovascular events in the last 6 months, that is, myocardial infarction, effusions, etc. • Supine or sitting systolic blood pressure (PS)> 160 mmHg or diastolic blood pressure> 95 mmHg at the time of selection. • Postural symptomatic hypotension in the last 6 months • Psychosis, uncontrolled bipolar disorder, uncontrolled depression • Previous failed participation in any research trial of an oral treatment for erectile dysfunction (eg, Sildenafil) • Participation in another study with a drug or device under investigation for 30 days prior to its inclusion in the study or that was planned during the study • Any condition that could interfere with the patient´s ability to provide informed consent, to follow the study instructions or that might confuse the interpretation of the study results • Any condition that endangers the participant in case of participating in this trial • Any simultaneous use of any therapy for erectile dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The score of the Sexual Encounter Profile (SEP score) of the patient and his partner will be the primary efficacy variable. The SEP scores will be summarized and presented in a tabular and graphical way, presenting the mean, minimum, maximum and standard deviations. Likewise, the N. Distributions of scores will be presented in a graphic manner. The patient will be provided with summaries of the answers to each individual question in the SEP with a measure of their agreement. Adequate additional data analysis will be conducted. A variable of secondary efficacy will be the responses of patients to a question regarding general satisfaction with the treatment administered. Measure:Efficacy Timepoints:In Visits 2, 3, 4, 6 and any Exclusion Visit. ; Outcome name:The incidence of adverse experiences emerging in the treatment will be tabulated by event and body system. The data will be presented in demographic tables with summaries of changes. ECG evaluations will be presented as normal or abnormal by individual patients. Concomitant medications will be presented as demographic tables. An interim analysis of the safety variables has been scheduled after the patients complete the visit 4. Measure:Safety Timepoints:Duration of the study | — |
Outcome results
None listed