An Open Label Study to Assess the Effect of Euryco-10® Oral Dietary Supplement in Senior Men

• Conditions: Healthy Aging

• Registration Number: NCT04584918
• Lead Sponsor: Innovus Pharmaceuticals, Inc.

Brief Summary

To evaluate the effect and support the tolerance of orally ingested formulation containing Eurycoma longifolia dietary supplement (Euryco-10) on a cohort of senior men.

Detailed Description

This is a single-center, single arm, open label study in senior men. This study will investigate the effect and tolerance of oral ingestion of Euryco-10. Subjects meeting all inclusion and none of the exclusion criteria will be enrolled and provided with study dietary supplement. Subjects will be instructed to take 2 capsules per day for 35 days. Administration and any adverse events will be recorded in the subject diary. At each clinic visit (Day 0, Day 21 and Day 35) the Subject will complete the AMS Questionnaire.

Study Timeline

• Status Verified: 2020-10
• Study Start: 2020-10
• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-08
• Last Update Submitted: 2020-10-08
• Study First Posted: 2020-10-14
• Last Update Posted: 2020-10-14
• Primary Completion: 2021-01
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

Male ≥ 55 years of age

Exclusion Criteria

Severe lower urinary tract symptoms.

Current use of any herbal and/or nutritional supplements that can interfere with testosterone.

A history of cancer except melanoma skin cancer.

Currently receiving treatment with cancer chemotherapy or antiandrogens.

Chronic use of systemic glucocorticoids (use within >14 days up to the 3months prior to screening); use of non-testosterone anabolic steroids within12 months prior to screening.

History of frequent opioid use >1 time/week during any week within 30 days prior to screening.

Have a history of known angina.

Have a history of severe liver disease or clinical evidence of hepatic impairment at screening.

Untreated severe obstructive sleep apnea.

Allergies to any of the ingredients in Euryco-10® or BioPerine.

Any condition which would interfere with the subject's ability to provide informed consent, to comply with study instructions, or which might confound the interpretation of the study results

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in serum total testosterone concentration compared to baseline	Day 0, Day 21 and Day 35

Secondary Outcome Measures

Name	Time	Method
Change in Q 9 of the AMS Questionnaire	Day 0, Day 21 and Day 35
Change in Q17 of the AMS Questionnaire	Day 0, Day 21 and Day 35

Trial Locations

Locations (1)

San Diego Sexual Medicine; 🇺🇸 San Diego, California, United States