Healthy AgingNCT04584918
An Open Label Study to Assess the Effect of Euryco-10® Oral Dietary Supplement in Senior Men
An observational study of Healthy Aging, run by Innovus Pharmaceuticals, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2020to Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample
Who may be able to join
- Male ≥ 55 years of age
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego Sexual Medicine
San Diego, California, 92120
Jo Anna Williams, 619-265-7695, jwilliams@sdsm.info
Irwin Goldstein, MD
About this study
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
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.
Read the 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.
- Conditions
- Healthy Aging
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum total testosterone concentration compared to baseline
Measured: Day 0, Day 21 and Day 35
Secondary outcomes (2)
Change in Q 9 of the AMS Questionnaire
Measured: Day 0, Day 21 and Day 35
Change in Q17 of the AMS Questionnaire
Measured: Day 0, Day 21 and Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study startOct 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584918
- Sponsor's protocol ID
- INNV-BHT1000-001
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04584918
- Acronym / sponsor ID
- INNV-BHT1000-001
- Conditions
- Healthy Aging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Innovus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 55 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (1 listed)
- Male ≥ 55 years of age
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in serum total testosterone concentration compared to baseline
Time frame: Day 0, Day 21 and Day 35
2 secondary outcomes
Change in Q 9 of the AMS Questionnaire
Time frame: Day 0, Day 21 and Day 35
Change in Q17 of the AMS Questionnaire
Time frame: Day 0, Day 21 and Day 35
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Aging, run by Innovus Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum total testosterone concentration compared to baseline (time frame: Day 0, Day 21 and Day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.