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

An Open Label Study to Assess the Effect of Euryco-10® Oral Dietary Supplement on Total Testosterone, Sex Drive and Energy Level in Senior Men

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Aging

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 Type: Observational
• Enrollment (Anticipated): 12

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92120
      • San Diego Sexual Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

community sample

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in serum total testosterone concentration compared to baseline	Day 0, Day 21 and Day 35

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Innovus Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: INNV-BHT1000-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No