None listed
Conditions
Interventions
Group 1 Type of group
1.0 mg of sumanirole once a day, three times a week
Group name:Group 4 Type of group
placebo once a day, three times a week
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: • Male Subject> 18 and <75 years of age • Subject diagnosed with a history of erectile dysfunction (unable to obtain and maintain an erection firm enough for intercourse with a partner in 50-100% of attempts) of at least 3 months duration while attempting sexual activity. • Subject without any treatment for erectile dysfunction during the last 4 weeks prior to randomization. • Subject who has a stable heterosexual and monogamous relationship and has had it for the past 3 months. The female partner (if potentially fertile) must use adequate methods of contraception (oral hormonal contraceptives, hormonal implants, hormone replacement injections and IUDs with hormones); unless the subject has had a vasectomy or has azoospermia • Subject who agrees to take the study drug and try to have intercourse at least 2 times a week • Subject capable of understanding and signing the Consent Report Form after a full discussion of the nature of the treatment investigation and its risks and benefits.
Exclusion criteria
Exclusion criteria: • Subject with a history of radical prostatectomy, penile implant or anatomical deformation of the penis. • Subject with severe neurological disease (eg, spinal cord injury, Parkinson´s disease or multiple sclerosis, ie conditions with little opportunity for pharmacotherapy with a reasonable effect). • Subject with premature ejaculation disorder. • Subject with major psychiatric disorders, including affective disorder • Subject with diagnosed hormonal erectile dysfunction (that is, they have a serum testosterone level 180 mmHg / or diastolic BP> 100 mmHg when sitting, hypotension (systolic BP <90 mmHg when standing or recent recurrent vasovagal reactions). • Subject with recent onset (six months or less) of significant condition or conditions of illness. Such as serious infections, myocardial infarction, cerebral vascular disease, sustained arrhythmias of clinical significance; as atrial fibrillation, etc., or any other condition of major or systemic organs. Or a non-stable medical problem that, in the opinion of the researcher, could contraindicate the administration of study drugs, which interferes with the evaluation of the study or with the subject´s ability to comply with the study protocol. • Subject who in the past 4 weeks has taken concomitant medications that could increase penile erection, such as alpha-adrenergic receptor blockers, yohimbine agonists or dopamine (Dostinex, Premax, Parlodel). • Subject who has received any investigational medication during the last 4 weeks or plans to use any medication / vacuum device (except study drug) during the study for the treatment of erectile dysfunction. • Subject currently receiving androgens or trazodone. • Subject with cross-reactivity prior to any opioid or dopamine agonist. • Subject to smoking more than 20 cigarettes per day, or the use of tobacco equivalent in other ways. • Subject with a history of alcoholism or substance abuse within the past 12 months. • Subjects that in the opinion of the Investigator should not be included due to other medical reasons.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The time in minutes from the taking of the drug to the beginning of the first sign of tumescence will be evaluated by the subject. Measure:Assessment of the subjects at the time of the beginning of the erection Timepoints:Daily registry by the patient ; Outcome name:es definida como el tiempo desde el inicio de la tumescencia hasta el inicio de la destumescencia. Measure:Duration of erection Timepoints:Daily registry by the patient ; Outcome name:The erection has to be evaluated on a scale of 5 points by the subject (manual palpation). Points 4 and 5 indicate the quality and duration of sufficient stiffness for sexual intercourse. 1 = No answer 2 = Some elongation 3 = Complete lengthening (but not stiff enough for intercourse). 4 = Complete lengthening, sufficient rigidity for intercourse. 5 = Complete rigidity Measure:Valuation of the subjects of the PRI index assessed according to a scale of five points Timepoints:Daily registry by the patient ; Outcome name:Evaluation of the Patients diary Measure:Estimation of the subjects of treatment success (with which at least 50% of the administrations were successful in the treatment period). Timepoints:At the end of the treatment ; Outcome name:Patients diary evaluation Measure:Number of intercourse attempts Timepoints:At the end of the treatment ; Outcome name:Response to Please rate your satisfaction with intercourse: very dissatisfied (0), unsatisfied for the most part (1), neutral or mixed - equally satisfied and dissatisfied (2), satisfied for the most part (3) at very satisfied (4) and his record in the newspaper Measure:Satisfaction of the subject and his partner with intercourse according to a scale of four points. Timepoints:Daily registry by the patient ; Outcome name:International Index of Erectile Function (IIFE) Measure:Change in questionnaire of the International Index of Erectil | — |
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Answer to the daily question Did you get and maintain an erection that was firm enough for intercourse? as registered in the patients diary Measure:Answer to the daily question Did you get and maintain an erection that was firm enough for intercourse? Timepoints:Daily registry | — |
Outcome results
None listed