CTRI/2009/091/000099UnknownPhase 2
A Triple blind, placebo controlled, randomized study to evaluate the Safety and Efficacy of VigRX Plus capsules as a dietary supplement to improve erectile function and maintain Male Sexual Health
DM Contact Management Ltd6 sites in 1 country72 target enrollmentStarted: TBD
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 72
- Locations
- 6
- Primary Endpoint
- 1- International Index of Erectile Function (SubScore A)
Study Overview
Brief Summary
About 72 males between 25-50 years of age will be recruited to get 60 completed/ evaluable subjects. Recruitment of subjects will be done through the investigator?s own direct contact subjects or subject referral to the selected investigators.For each subject, the study will terminate after a maximal period of 84 days from enrollment and will include 5 visits.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 25.00 Year(s) to 50.00 Year(s) (—)
- Sex
- Male
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
- •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 diabetes4.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 functioning6.Subject is a k/c/o HIV or AIDS7.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 dependence9.Subject is using medications that are known to cause sexual dysfunction (cimetidine, spironolactone, thiazides, β-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 same17.Subject not ready to sign the consent & unable to comply with the protocol18.Subjects whose female partners are Pregnant.
Outcomes
Primary Outcomes
1- International Index of Erectile Function (SubScore A)
Time Frame: 1- Screening , Baseline , Day 28, Day 56 , Day 84
Secondary Outcomes
- 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 version4-Semen Analysis Parameters 5-Serum Testosterone (Total) levels 6-Safety assessment parameters(1- Screening, Baseline , Day 28, Day 56 , Day 842- Screening, Baseline , Day 28, Day 56 , Day 843- Day 28 & Day 56, Day 84 (Patient) & Day 28 & Day 84 (Partner) 4- Screening & day 845- Screening & day 846- Screening, Baseline , Day 28, Day 56 , Day 84)
Investigators
Study Sites (6)
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