Clinical trial NCT06571318: Clinical Study to Reduce Premature Ejaculation in Healthy Adult Men
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Premature Ejaculation
Stress
Keywords: Premature Ejaculation
Stress
Lead sponsor: Herbolab India Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 60
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double blind, Parallel Group, Placebo Controlled Trial
Primary purpose: SUPPORTIVE_CARE

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 1:1:1 ratio. The treatment duration will be 60 days. The efficacy of the investigational products will be compared between the groups.

Concomitant diseases/medication 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, i.e., 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.

Eligibility criteria: Inclusion Criteria:

1. Male participants aged 21-50 years both inclusive suffering from a. PE or b. ED
2. Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26
3. Participant having baseline IELT of less than 2 min
4. Participants meeting with diagnostic criteria for PEP score greater than or equal to 11
5. 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
6. Participants should be in an active stable sexual relationship only married participants for the entire duration of the study
7. Participants willing to participate in clinical trials and who have read understood and signed the informed consent form.

Exclusion Criteria:

1. Previous events or other severe conditions that may affect premature ejaculation/erectile dysfunction, including but not limited to spinal trauma or pelvic surgery
2. Participants with genital anatomical deformities, including but not limited to penile deformities
3. Participants for whom sexual activity is inadvisable because of their underlying disease status
4. Female partners experiencing sexual dysfunction, such as painful intercourse, low libido, or other forms of sexual dysfunction, as well as pregnant individuals
5. 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
6. Participants that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs;
7. Participants with history or presence of significant alcoholism or drug abuse within the past 1 year
8. 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
9. Any concomitant treatment that is not permissible including but not limited to (nitrates, anti-androgens, chemotherapy agents, radiotherapy, etc).
10. Recent participation in another clinical trial or receiving some other drug during the study besides that in the protocol
11. Known hypersensitivity to any of the ingredients of investigational product
12. Participants concurrent use of sildenafil or other such drugs in the PDE5 inhibitor family, energy supplements, herbal or pharmaceutical aphrodisiacs, body composition enhancing agents, or other concurrent medication such as beta blockers, contraceptives, and psychotropic medications, nutraceutical, or ayurvedic supplement for stress and/or PE management
13. Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: Screening, day 30 and day 60
measure: Premature ejaculation assessed using Premature Ejaculation Profile (PEP) Questionnaire
timeFrame: Screening, day 30 and day 60
measure: Sexual stamina assessed using intravaginal ejaculatory latency time (IELT)
timeFrame: Screening, day 30 and day 60
measure: libido system score (LSS)
timeFrame: Screening, day 30 and day 60
measure: Changes in serum testosterone
timeFrame: Screening, day 30 and day 60
measure: Changes in Lactate dehydrogenase(LDH)
timeFrame: Screening, day 30 and day 60
measure: Body Mass Index (BMI)
timeFrame: Screening, day 30 and day 60
measure: COPE Questionnaire
timeFrame: Screening, day 30 and day 60
measure: Assessment of Maximum oxygen consumption
timeFrame: Screening, day 30 and day 60
measure: Assessment of % fat using bioelectrical impedance analysis (BIA)
timeFrame: Screening, day 30 and day 60
measure: Assessment of % skeletal muscle using bioelectrical impedance analysis (BIA)
timeFrame: Screening, day 30 and day 60
measure: Handgrip strength
timeFrame: Screening, day 30 and day 60
measure: STAI (State-Trait Anxiety Inventory)
timeFrame: Screening and day 60
measure: Profile of Mood State (POMS) questionnaire
timeFrame: Screening and day 60
measure: Intimacy problems
timeFrame: Screening and day 60
measure: Assessment of blood flow
timeFrame: Screening and day 60
Secondary outcomes:
measure: Safety of participant Assessed using adverse events
timeFrame: Screening, baseline, day 30, day 60
measure: Safety of participant Assessed using treatment compliance and tolerability of investigational product
timeFrame: Screening, baseline, day 30, day 60
measure: Systolic blood pressure difference from reference measurement (mmHg)
timeFrame: Screening, baseline, day 30, day 60
measure: Diastolic blood pressure difference from reference measurement (mmHg)
timeFrame: Screening, baseline, day 30, day 60
measure: Pulse rate difference from reference measurement (beats per minute)
timeFrame: Screening, baseline, day 30, day 60
measure: Complete blood count
timeFrame: Screening and day 60
measure: Serum Glutamic Pyruvic Transaminase (SGPT)
timeFrame: Screening and day 60
measure: Serum glutamic-oxaloacetic transaminase (SGOT)
timeFrame: Screening and day 60
measure: Creatinine difference from reference measurement (mg/dl)
timeFrame: Screening and day 60
Other outcomes:
Locations:
Study officials:
affiliation: Lokmanya Medical Research Centre and Hospital
name: Dr. Ramshyam Agarwal, MBBS, DNB
role: PRINCIPAL_INVESTIGATOR
References: