A Single Centric, Open-Label, Non-Randomized Clinical Study to evaluate the Efficacy and Safety of LYCO3 in Male Subjects Suffering from Erectile Dysfunction

utragen Pharma Pvt. Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•1) Male participants aged above 18 years who are in good health.
•2) Participants with a Body Mass Index (BMI) less than 40.
•3) Individuals with a positive Androgen Deficiency in Aging Males (ADAM) questionnaire score, defined as an affirmative response (yes) to either of the following questions: Do you have a decreased sex drive/libido? or Are your erections less strong? or a positive response to any three other questions on the ADAM questionnaire.
•4) Individuals with an International Index of Erectile Function (IIEF) assessment score between 11-25.
•5) Individuals willing to engage in at least four sexual encounters over next 8-week period.
•6) Men who are committed to refraining from the use of phosphodiesterase 5 inhibitors (e.g., Viagra, Levitra, Cialis), supplements, or other herbal supplements throughout the study duration.
•7) Subjects willing to provide written informed consent and adhere to all study procedures.

•1) Individuals with current or previous history of prostate or testicular cancer.
•2) Participants with a past surgical history of prostatectomy.
•3) Men who have received past or current treatment for erectile dysfunction, including intracavernosal injections or penile prosthesis.
•4) Use of steroids within the past 3 months, including prednisone, cortisone injections, and inhaled steroids.
•5) History of or current use of anabolic steroids (e.g., testosterone), testosterone analogs (e.g., DHEA, DHEAS), antidepressants, or anti-androgen medications (e.g., aldactone, tagamet, estrogens).
•6) History of spinal cord injury; and use of systemic anticoagulants (e.g., coumadin, clopidogrel).
•7) Presence of clinically significant medical conditions, including but not limited to cardiovascular, neurological, psychiatric, hepatic, renal, immunological, endocrine disorders (such as uncontrolled diabetes or thyroid disease), or haematological abnormalities.
•8) Active smokers or individuals with a history of high alcohol intake (2 standard drinks per day).
•9) Known hypersensitivity to herbal drugs, nutritional supplements, or foods.

发起方

utragen Pharma Pvt. Ltd.