PER-023-01
Completed
未知
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
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,0 sites0 target enrollmentMay 28, 2001
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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).
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
Evaluation of erectyle disfonction in patients suffering from testosterone deficiency, before and after tretament by TestopatchTestosterone deficiencyErectile dysfunctionMedDRA version: 9.1Level: LLTClassification code 10061461Term: Erectile dysfunctionMedDRA version: 9.1Level: LLTClassification code 10058359Term: HypogonadismEUCTR2007-007670-38-FRPierre Fabre Médicament104
Recruiting
Not Applicable
Evaluation of Mesenchymal Stem Cell transplantation (MSCS) in the treatment of Erectile Dysfunction (ED)IRCT20190624043991N11Tehran University of Medical Sciences100
Not yet recruiting
Phase 1
Clinical evaluation of treatment of erectile dysfunction with miao medicine, bamboo technique and moxibustioErectile dysfunctionITMCTR2100005318Guizhou University of Chinese Medicine
Recruiting
Phase 3
Evaluation of the effectiveness of Erectofix device for erectile dysfunctioIRCT20111121008146N40Shahid Beheshti University of Medical Sciences56
Completed
Not Applicable
Proportion of diabetes patients suffering from sexual dysfunctioHealth Condition 1: null- Diabetes mellitusCTRI/2018/02/011885Bangalore Baptist Hospital180