DOSAGE RANGE IN PATIENTS WITH ERECTIL DYSFUNCTION EVALUATING THE EFFICACY AND SAFETY OF SUMANIROLE, RANDOMIZED STUDY, DOUBLE-BLIND PLACEBO CONTROLLED, PARALLEL, 4 WEEKS, HOME TREATMENT

Not Applicable

• Conditions: -F529 Unspecified sexual dysfunction, not caused by organic disorder or disease; Unspecified sexual dysfunction, not caused by organic disorder or disease; F529

• Registration Number: PER-023-01
• Lead Sponsor: PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-05-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

• 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 <280 ng / dL, serum prolactin <20 ng / dL).
• Subject with diabetes that is unstable as evidenced by serum glucose above 250 mg / ml or recent episodes of ketoacidosis or whose hemoglobin Ale values ​​indicate instability (outside the normal range or are considered to be clinically significant by the investigator ).
• Subject that has laboratory selection values ​​that are 20% or greater outside the normal range of clinical values ​​or are considered clinically significant by the investigator.
• Subject with cardiovascular disease not stable (for example, systolic PS> 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified