None listed
Conditions
Interventions
None listed
Sponsors
Ixoreal Biomed
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male participants between 30 to 50 years of age having poor sexual satisfaction based on his own perception since at least past 3 months. 2.Participants whose IIEF-EF domain score is between 11 to 16 (i.e. moderately impaired). 3.Participants in a stable, monogamous behaviour and heterosexual relationship. 4.Participants who are willing to stay away from any other medicines or treatments for Erectile Dysfunction (ED) during this study period. 5.Participants who are willing to have 4 or more attempts of sexual intercourse each month. 6.Participants who are willing to take proper contraceptives during the study and within 3 months after the study completed. 7.Participants who have voluntarily decided to participate in this study and signed the informed consent form. 8.Participants having sufficient understanding to communicate effectively with the investigator and are willing to discuss their sexual functioning with the investigative staff. 9.Participants who are reliable, honest, compliant, and agree to cooperate with all trial evaluations as well as to be able to perform them as per investigatorâ??s opinion. 10.Participants willing to follow the protocol requirements and agree to take an investigational product till Day 56 ± 3.
Exclusion criteria
Exclusion criteria: 1. Participants on any medication or supplement (e.g., ginseng, Sildenafil, vardenafil, tadalafil, avanafil) for improving the sexual function during the 3 months prior to study commencement. 2. Participants having any clinically significant medical history, medical finding or an on-going medical or psychiatric condition or any acute illness which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol. 3. Individuals participating in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements (for improving the sexual function during the 3 months prior to study commencement). 4. Participants having a history of hypersensitivity reactions (i.e., allergic or oversensitivity to usual doses). 5. Participants with anatomical malformations of the penis. 6. Participants with primary hypoactive sexual desire. 7. Participants with ED, which is caused by any other primary sexual disorder, like hypopituitarism, hypothyroidism, or hypogonadism. 8. Participants who have a spinal injury or have had a radical prostatectomy 9. Participants with ED, which is caused by the failure of surgery in the pelvic cavity. 10. Participants with penis deformity or penile implants. 11. Participants with a history of malignancy. 12. Participants with a major refractory psychiatric disorder or significant neurological abnormalities. 13. Participants with alcohol addiction or persistent abuse of drugs of dependence. 14. Participants who are participating or discontinued participation in the past 3 months from any other clinical trial or are planning to father a baby or are in a relationship with a pregnant partner.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean change in SDI-2 score from Baseline Visit (Day 1) to End of study (Day 56) in healthy men 2. Mean change in SSEs score from Baseline Visit (Day 1) to End of study (Day 56) in healthy menTimepoint: Baseline and Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in IIEF score from Baseline Visit (Day 1) to End of study (Day56) in healthy men 2. Mean change in seminogram parameters from Baseline Visit (Day 1) to End of study (Day 56) 3. Change in mean serum Testosterone Hormone Levels (total & free) from Screening Baseline Visit (Day 1) to End of study (Day 56) in healthy men 4. Mean change in SF-12 (QoL) scores from Baseline Visit (Day 1) to End of study (Day 56) in healthy men 5. Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event (TESAE)Timepoint: Baseline and Day 56 | — |
Countries
India
Contacts
Public ContactMr Sohal Pendse
ProRelix Services LLP
Outcome results
None listed