CTRI/2024/03/064755Not yet recruitingPhase 3 4
A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Comparative Evaluation of TLF-20 on Relevant Sexual Biomarkers in Middle Aged Men with Low Testosterone.
Akay Natural Ingredients Pvt. Ltd1 site in 1 country60 target enrollmentStarted: April 1, 2024Last updated:
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To evaluate the effect of the TLF-20 compared to placebo on free testosterone, total testosterone, bioavailable testosterone, sex hormone binding globulin (SHBG), albumin, estradiol (E2), Dehydroepiandrosterone sulfate (DHEA-S) levels.
Study Overview
Brief Summary
This is a randomized (1:1:1), double-blind, active-controlled clinical study. Subjects meeting all inclusion and no exclusion criteria will sign a written informed consent and will be enrolled in the study. After passing the eligibility criteria, subjects will be randomized into Placebo, 500mg of TLF-20, and 100mg of TLF-20, respectively for 12 weeks. All assessments will be performed for Baseline, Day 28, Day 56 and Day 84. Blood samples will be collected for safety and biomarker analysis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 35.00 Year(s) to 50.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •Subjects with morning total testosterone level less than 300 ng/dL
- •Subject with androgen deficiency symptoms assessed by Androgen Deficiency in Aging Male (ADAM) questionnaire items 1 or 7 or any 3 other questions as positive
- •Subjects with Basal Metabolic Index (BMI) greather than 25 Kg per m2
- •Subjects with no history of surgical or medical castration, diagnosed erectile dysfunction or any physical disability that may limit sexual function
- •Non-smoker
- •Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study.
Exclusion Criteria
- •Subjects with history of Uncontrolled diabetes and hypertension, Diagnosable mental health disorder e.g., depression, anxiety disorder, eating disorder, psychosis/ schizophrenia,Cancer, thyroid diseases, liver and gall bladder diseases, renal failure, chronic fatigue syndrome, asthma, cardiovascular disorders,Subjects diagnosed with prostate cancer or benign prostatic hypertrophy, had an acute genitourinary disorder or history of genital surgery, Untreated hypothyroidism, hypercortisolism or other significant endocrinopathy that contributes to symptoms of low energy or fatigue, Any recent major stressful episodes like surgery, accidents, death in family etc
- •Subjects who has been administered any PDE-V inhibitors (sildenafil, tadalafil, or vardenafil) and chemotherapy, corticosteroid, anticoagulation, testosterone, antiandrogen medication within the four weeks prior to enrollment and during the entire course of the study
- •Subjects undergone any treatment/ therapy for any sexual disorder during last 6 months
- •Subjects having symptoms of viral infection
- •Subjects with known hypersensitivity to Ashwagandha extract
- •History of smoking, alcohol/drug abuse
- •Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
- •History of clinically significant illness or any other medical disorder or any disabilities that significantly affect the data collected, such as severe deafness or blindness that may interfere with subject treatment, assessment or compliance with the protocol.
- •Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
Outcomes
Primary Outcomes
To evaluate the effect of the TLF-20 compared to placebo on free testosterone, total testosterone, bioavailable testosterone, sex hormone binding globulin (SHBG), albumin, estradiol (E2), Dehydroepiandrosterone sulfate (DHEA-S) levels.
Time Frame: Day 0, Day 28, Day 56, Day 84
Secondary Outcomes
- To assess the safety and efficacy of TLF-20(Day 0, Day 28, Day 56, Day 84)
Investigators
Dr Shashank S Gowda
BGS Global Institute of Medical Sciences
Study Sites (1)
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