A clinical trial to study the effect of ProSolution pills in enhancing sexual function of men with erectile dysfunctio
- Conditions
- Health Condition 1: null- Erectile Dysfunction
- Registration Number
- CTRI/2010/091/001506
- Lead Sponsor
- eading Edge Marketing, PO Box CR-56766, Suite 1210Nassau Bahamas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 84
Males aged 25-50 years, involved in a stable heterosexual relationship of >6 months
Subjects with Erectile Dysfunction (ED) since at least 3 months
IIEF-A (Erectile Function) score in the range of 11 ? 23
IIEF-B score (Other than Erectile Function) in the range of 21 - 35
Significant cardiovascular or any other co-morbidities
Use of sildenafil or any other phosphodiesterase type inhibitor within previous 6 weeks
Current use of any other therapy for treatment of ED
Subjects with Diabetes
Subjects with Hypertension
Subjects taking medications known to cause ED
Subjects with major psychiatric disorders
Subjects with Low Testosterone Levels (<200 ng/dl)
Subjects with history of spinal cord injury or a radical prostatectomy or radical pelvic surgery.
Subjects with anatomical deformity of the penis which has a severe effect on sexual functioning
Subjects with HIV or AIDS or any other sexually transmitted disease
Subjects with Hyperprolactinemia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method International Index for Erectile FunctionTimepoint: Screening Visit (i.e. on Day -3), Day 28, Day 56 and Day 84
- Secondary Outcome Measures
Name Time Method 1) EDITS Patient and Partner Questionnaire <br>2) Serum Testosterone Levels<br>3) Erection hardness score (EHS)<br>4) Global Assessment by the Investigator<br>Timepoint: 1) Day 84<br>2) Screening Visit and Day 84<br>3) Screening Visit, Day 28, Day 56 and Day 84<br>4) Day 84<br>