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

Healthy Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04584918
• Other study ID #: INNV-BHT1000-001
• Status: Not yet recruiting
• Start date: October 2020
• Est. completion date: January 2021

Study information

• Verified date: October 2020
• Source: Innovus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Aging

Locations

Country	Name	City	State
United States	San Diego Sexual Medicine	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Innovus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum total testosterone concentration compared to baseline		Day 0, Day 21 and Day 35
Secondary	Change in Q 9 of the AMS Questionnaire		Day 0, Day 21 and Day 35
Secondary	Change in Q17 of the AMS Questionnaire		Day 0, Day 21 and Day 35