Health Condition 1: null- Sexual Health
Conditions
Interventions
Intervention1: VigRX PLus: 2 capsules twice a day with meals for 12 weeks
Control Intervention1: Placebo: 2 capsules twice a day with meals for 12 weeks
Sponsors
DM Contact Management Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male subjects aged between 25-50 years 2. Subject having a monogamous, heterosexual relationship 3. Male subjects with IIEF-A score 11 to 23 & IIEF-B score 21 to 35 at screening visit & baseline visit 4. Subject provides written informed consent and comes for regular follow up
Exclusion criteria
Exclusion criteria: 1. Subjects with major psychiatric disorders 2. Subjects having a history of stroke, myocardial infarction, coronary artery disease, cardiac failure, angina, life-threatening arrhythmia within the past 6 months. 3. Subject has a history of diabetes 4. Subject has a history of spinal cord injury or a radical prostatectomy or radical pelvic surgery. 5. Subject has an anatomical deformity of the penis which has a severe effect on sexual functioning 6. Subject is a k/c/o HIV or AIDS 7. Subject is know to suffer from STDs at screening visit 8. Subject is a chronic alcoholic showing withdrawal symptoms or subjects having medication (opiates etc) or drug (marijuana, cocaine etc)/ Nicotine/Caffeine dependence 9. Subject is using medications that are known to cause sexual dysfunction (cimetidine, spironolactone, thiazides, &#946;-adrenergic blockers, anti- depressants etc.) 10. Subject has a major illness that in the opinion of the investigator would interfere with the conduct of the study. 11. Subject has participated in a clinical drug study within the last 30 days prior to entering this study. 12. Subject with Liver dysfunction as evidenced by SGPT level of 1.5 X ULN. 13. Subject with Renal dysfunction as evidenced by Serum Creatinine level of 1.5 X ULN. 14. Subject has an abnormal thyroid stimulating hormone (TSH) level lower than 30% of LLN or more than 30% of ULN. 15. Subject has erectile dysfunction caused by neurological or endocrine factors such as hyperprolactinemia or low serum testosterone levels (<200 ng/dl). 16. Subjects already taking any medications for the study indication & do not wish to discontinue the same 17. Subject not ready to sign the consent & unable to comply with the protocol 18. Subjects whose female partners are Pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1- International Index of Erectile Function (SubScore A)Timepoint: 1- Screening , Baseline , Day 28, Day 56 , Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-International Index of Erectile Function (Total) 2-International Index of Erectile Function (Sub Score B) 3-Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Patient & partner version 4-Semen Analysis Parameters 5-Serum Testosterone (Total) levels 6-Safety assessment parametersTimepoint: 1- Screening, Baseline , Day 28, Day 56 , Day 84 2- Screening, Baseline , Day 28, Day 56 , Day 84 3- Day 28 & Day 56, Day 84 (Patient) & Day 28 & Day 84 (Partner) 4- Screening & day 84 5- Screening & day 84 6- Screening, Baseline , Day 28, Day 56 , Day 84 | — |
Countries
India
Contacts
Public ContactDr.Aliya Shakeel
Medical Writer
Outcome results
None listed