Lower Urinary Tract SymptomsNCT06504472
A Randomized Triple-Blind Placebo-Controlled Study to Evaluate the Effects of a Supplement on Lower Urinary Tract Symptoms in Men.
A study testing ProstaThrive™ Supplement in people with Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, run by Optimale at 1 site in United States.
Trial summary
This study aims to evaluate the effects of the ProstaThrive™ supplement on lower urinary tract symptoms (LUTS) in men. It is a 90-day virtual, randomized, placebo-controlled trial with 80 male participants aged 40 and above. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia, Erectile Dysfunction
- What is being tested?
- ProstaThrive™ Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2024to 24 Jun 2024
- Phase
- Interventional
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male participants aged 40+
- Experience symptoms such as frequent nighttime urination, incomplete bladder emptying, weak urinary stream, and frequent daytime urination
- Difficulty in getting or maintaining an erection
- Willing to avoid introducing any new products or medications targeting LUTS or erectile dysfunction during the study period
Who cannot join
- Recent surgeries or invasive treatments
- History of prostate or male reproductive cancers
- Urinary issues caused by neurological conditions
- Previous surgery on the genitals, prostate, bladder, or urethra
- Known allergies to product ingredients
- Diagnosed with chronic health conditions impacting study participation
Show all 9Show fewer
- Current substance abuse
- Participation in other clinical trials
- Taking medications or supplements targeting LUTS or erectile dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the effects of the ProstaThrive™ supplement on lower urinary tract symptoms (LUTS) in men. It is a 90-day virtual, randomized, placebo-controlled trial with 80 male participants aged 40 and above. The primary endpoint is the reduction in LUTS, while secondary endpoints include changes in sexual function and performance.
Read the detailed description
This is a virtual two-arm randomized placebo-controlled clinical trial lasting 90 days. Participants will take the ProstaThrive™ supplement or a placebo daily and complete questionnaires at Baseline, Day 30, Day 60, and Day 90. The study will assess the efficacy of ProstaThrive™ on LUTS such as urinary urgency, nighttime urination frequency, perceived urinary flow, and bladder emptying, as well as secondary outcomes related to sexual function.
- Being tested
- ProstaThrive™ Supplement, Placebo
- Keywords
- Pumpkin Seed Extract, Lycopene, Stinging Nettle, Beta-Sitosterols
- Medical subject headings
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProstaThrive™ SupplementDietary supplement
Participants in this arm will take three ProstaThrive™ capsules daily after the final meal of the day for 90 days.
PlaceboDietary supplement
Participants in this arm will take three placebo capsules daily after the final meal of the day for 90 days. The placebo capsules will contain an inert substance that mimics the appearance of the ProstaThrive™ supplement.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (ProstaThrive™) | Experimental | Participants will take three capsules daily after the final meal of the day for 90 days. Receives: Dietary Supplement: ProstaThrive™ Supplement |
| Placebo | Placebo comparator | Participants will take three placebo capsules daily after the final meal of the day for 90 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lower Urinary Tract Symptoms (LUTS)
Measured by urinary urgency, nighttime urination frequency (nocturia), perceived urinary flow, and perceived bladder emptying at Baseline, Day 30, Day 60, and Day 90 via questionnaires, including questions adapted from the International Prostate Symptom Score (IPSS).
Measured: Baseline, Day 30, Day 60, and Day 90
Secondary outcomes (1)
Change in Sexual Function and Performance
Measured by the ability to get and maintain an erection at Baseline, Day 30, Day 60, and Day 90 via study-specific questionnaires.
Measured: Baseline, Day 30, Day 60, and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start7 Feb 2024
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optimale
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504472
- Sponsor's protocol ID
- 20405
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Triple-Blind Placebo-Controlled Study to Evaluate the Effects of a Supplement on Lower Urinary Tract Symptoms in Men.
- ClinicalTrials.gov ID
- NCT06504472
- Acronym / sponsor ID
- 20405
- Keywords
- Pumpkin Seed Extract, Lycopene, Stinging Nettle, Beta-Sitosterols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- OptimaleIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 16 Jul 2024 (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.
This study aims to evaluate the effects of the ProstaThrive™ supplement on lower urinary tract symptoms (LUTS) in men. It is a 90-day virtual, randomized, placebo-controlled trial with 80 male participants aged 40 and above. The primary endpoint is the reduction in LUTS, while secondary endpoints include changes in sexual function and performance.
Detailed description
This is a virtual two-arm randomized placebo-controlled clinical trial lasting 90 days. Participants will take the ProstaThrive™ supplement or a placebo daily and complete questionnaires at Baseline, Day 30, Day 60, and Day 90. The study will assess the efficacy of ProstaThrive™ on LUTS such as urinary urgency, nighttime urination frequency, perceived urinary flow, and bladder emptying, as well as secondary outcomes related to sexual function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (ProstaThrive™) | Experimental | Dietary Supplement: ProstaThrive™ SupplementParticipants will take three capsules daily after the final meal of the day for 90 days. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will take three placebo capsules daily after the final meal of the day for 90 days. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male participants aged 40+
- Experience symptoms such as frequent nighttime urination, incomplete bladder emptying, weak urinary stream, and frequent daytime urination
- Difficulty in getting or maintaining an erection
- Willing to avoid introducing any new products or medications targeting LUTS or erectile dysfunction during the study period
Key exclusion criteria (9 listed)
- Recent surgeries or invasive treatments
- History of prostate or male reproductive cancers
- Urinary issues caused by neurological conditions
- Previous surgery on the genitals, prostate, bladder, or urethra
- Known allergies to product ingredients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProstaThrive™ SupplementParticipants in this arm will take three ProstaThrive™ capsules daily after the final meal of the day for 90 days. | Dietary supplement | Intervention (ProstaThrive™) |
| PlaceboParticipants in this arm will take three placebo capsules daily after the final meal of the day for 90 days. The placebo capsules will contain an inert substance that mimics the appearance of the ProstaThrive™ supplement. | Dietary supplement | Placebo |
Primary outcome
Change in Lower Urinary Tract Symptoms (LUTS)
Time frame: Baseline, Day 30, Day 60, and Day 90
Measured by urinary urgency, nighttime urination frequency (nocturia), perceived urinary flow, and perceived bladder emptying at Baseline, Day 30, Day 60, and Day 90 via questionnaires, including questions adapted from the International Prostate Symptom Score (IPSS).
1 secondary outcome
Change in Sexual Function and Performance
Time frame: Baseline, Day 30, Day 60, and Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProstaThrive™ Supplement in people with Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, run by Optimale 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 16 Jul 2024. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lower Urinary Tract Symptoms (LUTS) (time frame: Baseline, Day 30, Day 60, and Day 90). 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 16 Jul 2024; AzTrials last refreshed its copy on 28 Oct 2026.