Clinical Study to Reduce Premature Ejaculation in Healthy Adult Men (NCT06571318) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Study to Reduce Premature Ejaculation in Healthy Adult Men
60 participantsStarted 2024-09-05
Plain-language 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.
Who can participate
Age range21 Years – 50 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male participants aged 21-50 years both inclusive suffering from a. PE or b. ED
✓. Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26
✓. Participant having baseline IELT of less than 2 min
✓. Participants meeting with diagnostic criteria for PEP score greater than or equal to 11
✓. Participants who have scored 11 to 25 on the Erectile Function EF domain of the International Index of Erectile Function IIEF at screening visit a subset of 15 patients only that is 5 participants from each group
✓. Participants should be in an active stable sexual relationship only married participants for the entire duration of the study
✓. Participants willing to participate in clinical trials and who have read understood and signed the informed consent form.
Exclusion criteria
✕. Previous events or other severe conditions that may affect premature ejaculation/erectile dysfunction, including but not limited to spinal trauma or pelvic surgery
✕. Participants with genital anatomical deformities, including but not limited to penile deformities
✕. Participants for whom sexual activity is inadvisable because of their underlying disease status
✕. Female partners experiencing sexual dysfunction, such as painful intercourse, low libido, or other forms of sexual dysfunction, as well as pregnant individuals
What they're measuring
1
Perceived Stress Scale
Timeframe: Screening, day 30 and day 60
2
Premature ejaculation assessed using Premature Ejaculation Profile (PEP) Questionnaire
Timeframe: Screening, day 30 and day 60
3
Sexual stamina assessed using intravaginal ejaculatory latency time (IELT)
✕. Presence or history of any of the following disorders/disease within the past 3 months, that might have impact on the clinical trial as per the investigator discretion. cardiovascular, b) cerebrovascular, c) dermatological, d) gastrointestinal, e) gynaecological, f) hematological, g) hepatic, h) malignancy, i) metabolic, j) musculoskeletal, k) neurological, l) psychiatric, m) thyroid n) psychological, o) renal, p) respiratory, q) venereal, r) any other major disorders
✕. Participants that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs;
✕. Participants with history or presence of significant alcoholism or drug abuse within the past 1 year
✕. Participants with history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco/nicotine products more than 10 times per day
Assessment of Maximum oxygen consumption
Timeframe: Screening, day 30 and day 60
10
Assessment of % fat using bioelectrical impedance analysis (BIA)
Timeframe: Screening, day 30 and day 60
11
Assessment of % skeletal muscle using bioelectrical impedance analysis (BIA)