Health and Wellness Products for Sexual Health

Overseen By Study Manager

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Radicle Science

Must not be taking: Anticoagulants, Antidepressants, Antipsychotics, others

Disqualifiers: Cardiac dysfunction, Liver disease, Kidney disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how certain health and wellness products might enhance sexual health, such as boosting libido or satisfaction. Participants will receive either an active product, Spark Active Study Product 2.1, or a placebo (a harmless pill with no effect) to evaluate the effectiveness of these products. The trial seeks participants who have the potential to improve their sexual health by at least 30% and are willing to take a product without knowing if it is real or a placebo. As an unphased trial, this study offers participants the opportunity to contribute to innovative research in sexual health.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that could interact with the study products. These include blood thinners, blood pressure medications, anxiety and depression medications, cancer treatments, sleep aids, seizure medications, and others. If you are on any of these, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Spark Active Study Product 2.1 underwent testing in previous health and wellness studies. These studies did not identify any major safety issues. Participants generally tolerated the treatments well, with no significant reports of serious side effects. Since this trial is not assigned to a specific phase, it might be in early testing or follow a non-traditional approach, so safety remains under close observation. However, the absence of serious side effects in past research provides some reassurance about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Spark Active Study Product 2.1 and Active Product 1.1 because they offer a fresh approach to enhancing sexual health. Unlike traditional treatments that often focus on hormone levels or blood flow, these products may introduce new active ingredients specifically designed to improve sexual wellness in novel ways. They could potentially offer an alternative for individuals seeking different options beyond standard interventions like hormone therapy or PDE5 inhibitors. This innovation might pave the way for more personalized and effective treatments in the realm of sexual health.

What evidence suggests that this trial's treatments could be effective for sexual health?

Research has shown that Spark Active Study Product 2.1, which participants in this trial may receive, might improve sexual health. Earlier studies found it could boost sex drive and satisfaction by 30%, suggesting it might enhance sexual function. Similarly, Spark Product Form 1 active, another treatment option in this trial, demonstrated similar results, with improved sex drive and satisfaction. Both products are being studied in separate arms of this trial for their effects on sexual health. These findings make them promising options for those seeking to improve their sexual health. ^{3 4 6 7 8}

Who Is on the Research Team?

Emily K. Pauli, PharmD

Principal Investigator

Radicle Science

Are You a Good Fit for This Trial?

This trial is for men interested in improving sexual health and satisfaction. Participants should be experiencing some level of sexual dysfunction or dissatisfaction. The specific eligibility criteria are not provided, but typically include age range, general health status, and the nature of their sexual dysfunction.

Inclusion Criteria

Resides in the United States

I am a male aged 21 or older.

Endorses as improved libido (sex drive), sexual satisfaction and/or function as a primary desire

Exclusion Criteria

Unable to read and understand English

I cannot provide a valid US address and mobile number.

Reports current enrollment in another clinical trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study product or placebo for 6 weeks, with self-reported data collected electronically

6 weeks

No in-person visits; all assessments are electronic

Follow-up

Participants are monitored for safety and effectiveness after treatment through a final survey

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Spark Active Study Product 2.1
• Spark Placebo Control Form 1
• Spark Placebo Control Form 2

Trial Overview The study is testing the effects of two different 'Spark' active products against two placebo controls on men's sexual health and related outcomes. It's a randomized trial meaning participants are randomly assigned to one of the four groups without choice.

How Is the Trial Designed?

Group I: Active Product 2.1 Experimental Treatment 1 Intervention

Spark Product Form 2 - active product 1

Group II: Active Product 1.1 Experimental Treatment 1 Intervention

Spark Product Form 1 - active product 1

Group III: Placebo Control 1 Placebo Group 1 Intervention

Spark Product Form 1 - control

Group IV: Placebo Control 2 Placebo Group 1 Intervention

Spark Product Form 2 - control

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials

24

Recruited

46,200+

Published Research Related to This Trial

Participants in the primary intervention group maintained higher levels of moderate to vigorous physical activity (MVPA) 12 weeks after the intervention, although their sitting time slightly increased, indicating some sustainability of activity levels.

The waitlist control group, after receiving only the Garmin Vivofit 2 activity tracker, showed a significant increase in MVPA and a reduction in sedentary behavior, suggesting that wearable technology alone can effectively promote physical activity changes in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance of physical activity and sedentary behavior change, and physical activity and sedentary behavior change after an abridged intervention: Secondary outcomes from the ACTIVATE Trial. Lynch, BM., Nguyen, NH., Moore, MM., et al.[2020]

A pilot study involving 39 college students assessed the feasibility of using a real-time respiratory-based biofeedback device alongside mindfulness training, but found low adherence to the device and collaboration with the company, which hindered the study's effectiveness.

While all participants showed improvement in stress levels over time, there was no additional benefit from using the biofeedback device compared to mindfulness training alone, suggesting that the device did not enhance the intervention outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of using a biofeedback device in mindfulness training - a pilot randomized controlled trial. Lin, B., Prickett, C., Woltering, S.[2021]

In a 12-month feasibility study involving 16 participants aged 55-74 with obesity and elevated cardiovascular risk, the use of a Polar M430 activity tracker showed high adherence, with an average of 292 valid wear days (80% of the study duration).

Participants reported that the tracker helped them monitor their physical activity and heart rate, but issues like measurement inaccuracies and design preferences affected their experience, suggesting that better instructions and more appealing designs could enhance wear time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Succeeding with prolonged usage of consumer-based activity trackers in clinical studies: a mixed methods approach. Henriksen, A., Sand, AS., Deraas, T., et al.[2020]

Participants at moderate-to-high risk of developing type 2 diabetes engaged with real-time feedback from wearable technologies, which increased their self-awareness about how their lifestyle choices affected their health.

While some individuals changed their behaviors based on the feedback from the glucose and activity monitors, many did not, indicating a need for better training and support to help users effectively utilize the information for sustained lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A digital lifestyle behaviour change intervention for the prevention of type 2 diabetes: a qualitative study exploring intuitive engagement with real-time glucose and physical activity feedback. Whelan, ME., Denton, F., Bourne, CLA., et al.[2021]

Engaging consumers in health research is crucial for improving recruitment and retention strategies, as it aligns research with the needs and preferences of potential participants.

Projects that incorporate consumer input are often viewed more favorably by funding bodies and ethics committees, highlighting the importance of stakeholder involvement in research design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of consumer involvement in research. Halcomb, L.[2017]

Citations

1. sigma.larvol.com sigma.larvol.com/facility.php?FacilityId=19010426

Radicle Science, Inc Trials ... Study of Health and Wellness Products on Sexual Health and Related Health Outcomes ... Spark Placebo Control Form 2, Spark Active Study Product 2.1 Usage. Radicle ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06891547/radicle-spark-for-womentm-24-assessing-the-impact-of-health-and-wellness-products-on-sexual-health-and-related-health-outcomes?state=CA&city=Solana%20Beach

Assessing the Impact of Health and Wellness Products on ... Endorses improved libido (sex drive), sexual satisfaction and/or function as aprimary desire. Has the opportunity for at least 30% improvement ...

3. sigma.larvol.com sigma.larvol.com/facility.php?FacilityId=199518

Clearview Cancer Institute Trials NCT06590337: Radicle Spark for Men 24: A Study of Health and Wellness Products on Sexual Health and Related Health Outcomes. Completed. N/A.

4. withpower.com withpower.com/trial/phase-sexual-satisfaction-1-2025-5f1d2

Health and Wellness Products for Sexual Satisfaction The Spark Active Study Product 5.1 treatment is unique because it is part of a clinical trial specifically focused on health and wellness products for sexual ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3341956/

Patterns and Loss of Sexual Activity in the Year Following ... Lack of counseling was associated with loss of sexual activity 1 year later. Mortality was not significantly elevated among individuals who were sexually active ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06590337

Radicle Spark for Men 24: A Study of Health and Wellness ... Participants will use their Radicle Spark Active Study Product 2.1 as directed for a period of 6 weeks. What is the study measuring? Primary Outcome Measures ...

7. clinicaltrial.be clinicaltrial.be/en/details/450175?per_page=100&only_recruiting=1&only_eligible=0

Radicle Spark for Men 24: A Study of Health and Wellness... A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on sexual health and related ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06891547

Radicle Spark for Women™ 24: Assessing the Impact of ... A randomized, double-blind, placebo-controlled, direct-to-consumer study assessing the impact of health and wellness products on sexual health and related ...