Erectile dysfunction Urological and Genital Diseases Impotence of organic origin
Conditions
Interventions
Males aged 40-65 with mild erectile dysfunction were studied as outpatients in this double- blind, randomized, placebo-controlled, parallel-group pilot trial. Participants, researchers, and individual
Sponsors
Biotropics Malaysia Berhad (Malaysia)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male subjects between the ages of 40 and 65 at the time of screening, and in a stable heterosexual relationship for at least six months. Both partners had to agree to attempt intercourse at least once a week on average during the study. 2. Subjects with testosterone levels = 450ng/dL 3. Index of erectile dysfunction scores between17-25
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of prostate cancer, elevated prostate-specific antigen (PSA), benign prostate hypertrophy (BPH) scores = 40, penile anatomical abnormalities, premature ejaculation 2. Cardiovascular disease, resting hypotension (resting systolic blood pressure 170mmHg or diastolic pressure >110mmHg) 3. Primary hypoactive sexual desire 4. Seizures 5. Hereditary degenerative retinal disorders or loss of vision 6. Liver disease 7. Clinically significant chronic hematological disease, bleeding disorders 8. Significant active peptic ulceration 9. Symptomatic postural hypotension or syncope within the previous six months 10. Malignancy within the previous five years (other than squamous or basal cell) 11. A positive test for hepatitis B surface antigen or hepatitis C 12. Alcoholism (an alcohol screening score =2) 13. Congenital spinal cord deformities or traumatic injuries, congenital or traumatic brain injuries 13. An abnormal prostate exam during the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Index of Erectile Function (IIEF-5) is a six-point scale ranging from 0 to 5. The higher the score, the better the function 2. Erectile Dysfunction Inventory for Treatment Satisfaction (EDITS) Questionnaire is a point scale ranging from 0 to 4 3. Percentage of successful sexual intercourse attempts (SIA) (from patient event logs) 10 questions most of which are yes or no and are coded as 1 or 0, respectively 4. Erection Hardness Scale (EHS) is a four-point scale, with scores ranging from 1 to 4 5. Sexual Health Inventory Questionnaire is a six-point scale for each question, ranging from 0 to 5 6. Aging Male Symptom Score is a six-point Likert scale ranging from 0 to 5. A higher score indicates worse function Measured at screening, baseline, week 6, and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Self-Esteem and Relationship Questionnaire (SEAR) uses a six-point Likert scale ranging from 0 to 5. A higher score indicates better function 2. Beck Depression Index and Beck Anxiety Index The Beck Depression Inventory and Beck Anxiety Inventory score individual items on a four-point scale (0-3). Scores across domains are summed. Total scores =21 indicate concern for depression. Measured at screening, baseline, week 6, and week 12 | — |
Countries
United States of America
Outcome results
None listed