Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571318
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-10
Brief Title:
Clinical Study to Reduce Premature Ejaculation in Healthy Adult Men
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double Blind Placebo-controlled Parallel Arm Clinical Trial of De-Stress and Perform Capsule in the Management of Stress-induced Premature Ejaculation in Healthy Adult Men
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The current study focuses on clinical validation of efficacy of nutraceutical product in management of male health In healthy adult men with induced premature ejaculation the introduction of these nutraceuticals has been associated with notable improvements in quality of life These supplements help them for enhanced sexual satisfaction increased control over ejaculation and a reduction in performance anxiety The psychological benefits are significant as the improvement in sexual function can lead to higher self-confidence and a more positive outlook on life
Detailed Description:
This will be a randomized double-blind placebo-controlled parallel arm clinical trial of De-Stress and Perform Capsule in the management of stress-induced premature ejaculation in healthy adult men
More than 60 participants will be randomized into three groups Group A De-Stress and Perform Capsule-U001 20 participants Group B De-Stress and Perform Capsule-I001 20 participants Group C Placebo Capsule-002 20 participants in a 111 ratio The treatment duration will be 60 days The efficacy of the investigational products will be compared between the groups
Concomitant diseasesmedication assessment will be performed at screening
The efficacy of the intervention will be assessed by evaluating the following changes in Perceived Stress Scale PSS score changes in Premature Ejaculation Profile PEP score including PEP control PEP satisfaction PEP distress PEP relationship problems and PEP Index Score changes in sexual stamina using Intravaginal Ejaculatory Latency Time IELT score changes in Libido System Score LSS score changes in levels of serum testosterone cortisol and LDH changes in weight and BMI changes in COPE Questionnaire scores including Positive Subscale and Denial Subscale changes in fat and skeletal muscle using Bioelectrical Impedance Analysis BIA and changes in handgrip strength using a hand-held dynamometer assessed at screening day 30 and day 60
Additionally changes in blood flow will be assessed by penile Doppler in erectile dysfunction ED participants a subset of 15 participants ie 5 participants from each group Changes in State-Trait Anxiety Inventory STAI score changes in Profile of Mood States POMS questionnaire scores including Total Mood Disturbance and Depression changes in cardiorespiratory endurance maximal oxygen uptake VO2 max by steps test and changes in Personal Assessment of Intimacy in Relationships PAIR scores to be completed by partner will also be evaluated at screening and day 60
Treatment compliance and tolerability of investigational products will be assessed at day 30 and day 60 Safety of the investigational treatment in terms of adverse events AEs and serious adverse events SAEs will be assessed at baseline day 30 and day 60 Assessments of changes in vital sign parameters will be done thought the visit Assessments of changes in complete blood count liver function test and kidney function test will be done at screening and day 60
More than 60 participants will be randomized into three groups Group A De-Stress and Perform Capsule-U001 20 participants Group B De-Stress and Perform Capsule-I001 20 participants Group C Placebo Capsule-002 20 participants in a 111 ratio The treatment duration will be 60 days The efficacy of the investigational products will be compared between the groups
Concomitant diseasesmedication assessment will be performed at screening
The efficacy of the intervention will be assessed by evaluating the following changes in Perceived Stress Scale PSS score changes in Premature Ejaculation Profile PEP score including PEP control PEP satisfaction PEP distress PEP relationship problems and PEP Index Score changes in sexual stamina using Intravaginal Ejaculatory Latency Time IELT score changes in Libido System Score LSS score changes in levels of serum testosterone cortisol and LDH changes in weight and BMI changes in COPE Questionnaire scores including Positive Subscale and Denial Subscale changes in fat and skeletal muscle using Bioelectrical Impedance Analysis BIA and changes in handgrip strength using a hand-held dynamometer assessed at screening day 30 and day 60
Additionally changes in blood flow will be assessed by penile Doppler in erectile dysfunction ED participants a subset of 15 participants ie 5 participants from each group Changes in State-Trait Anxiety Inventory STAI score changes in Profile of Mood States POMS questionnaire scores including Total Mood Disturbance and Depression changes in cardiorespiratory endurance maximal oxygen uptake VO2 max by steps test and changes in Personal Assessment of Intimacy in Relationships PAIR scores to be completed by partner will also be evaluated at screening and day 60
Treatment compliance and tolerability of investigational products will be assessed at day 30 and day 60 Safety of the investigational treatment in terms of adverse events AEs and serious adverse events SAEs will be assessed at baseline day 30 and day 60 Assessments of changes in vital sign parameters will be done thought the visit Assessments of changes in complete blood count liver function test and kidney function test will be done at screening and day 60
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None