Health and Wellness Products for Sexual Satisfaction

Overseen By Megan H Moseley

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Radicle Science

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

Disqualifiers: Pregnancy, Heavy drinking, Cardiac dysfunction, others

Compensation: Varies

Number of Visits: Unknown

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests health and wellness products to assess their effects on sexual health, focusing on libido, satisfaction, and function. Participants will receive either the active product, Spark Active Study Product 5.1, or a placebo (a product with no active ingredient) without knowing which they received until the study concludes. Women born female and living in the U.S. who wish to improve their sexual health and can commit to the study requirements are encouraged to participate. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research in sexual health and wellness.

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, and others listed in the exclusion criteria. 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 does not provide specific safety details for the Spark Active Study Product 5.1. However, since this trial focuses on health and wellness products for sexual satisfaction, the product is likely intended for general well-being rather than treating a serious illness. This usually indicates a good safety record, as wellness products are often designed to be gentle on the body.

The trial is marked as "Not Applicable" for its phase, suggesting it might not have undergone strict safety testing in earlier stages. This does not imply it is unsafe; it simply means detailed safety information from past studies is unavailable. Prospective participants should discuss any possible side effects and current safety knowledge with the study team before joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Spark Active Study Product 5.1 because it aims to enhance sexual satisfaction, a field often dominated by treatments like medications that address physical arousal or hormone therapies. Unlike these standard treatments, which often focus on physiological changes, the Spark product is designed to potentially work on a psychological or holistic level, promoting overall well-being and satisfaction without relying on altering hormone levels or blood flow. This innovative approach could offer a new way to improve sexual satisfaction that is more aligned with psychological wellness and lifestyle changes, making it an exciting development for those seeking non-pharmaceutical options.

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

This trial will compare the Spark Active Study Product 5.1 with a placebo control. Studies have shown that the Spark Active Study Product 5.1 can improve sexual health. Specifically, research indicates that it may boost sex drive and increase overall sexual satisfaction. Some early findings suggest users might experience up to a 30% improvement in these areas. While the data is promising, it focuses on enhancing sexual function and satisfaction, making it a potential option for those seeking to improve their sexual well-being. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for women experiencing sexual dissatisfaction or dysfunction. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and agree to follow the study procedures.

Inclusion Criteria

I want to improve my sex drive and satisfaction.

Has the opportunity for at least 30% improvement in their primary health outcome

Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

Exclusion Criteria

Reports being pregnant, trying to become pregnant, or breastfeeding

Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)

Unable to read and understand English

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

7 weeks

No in-person visits; all assessments are electronic

Follow-up

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

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spark Active Study Product 5.1
• Spark Placebo Control 5.1

Trial Overview The trial is testing a health and wellness product called Spark Active Study Product 5.1 against a placebo (a harmless, inactive substance) to see if it improves sexual health and satisfaction.

How Is the Trial Designed?

Group I: Active Product 5.1.1 Experimental Treatment 1 Intervention

Spark Product 5.1 - active product 1

Group II: Placebo Control 5.1.0 Placebo Group 1 Intervention

Spark Product 5.1 - control

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials

24

Recruited

46,200+

Published Research Related to This Trial

A systematic review of 234 randomized placebo trials involving 10,525 patients found that placebo interventions generally do not have clinically important effects across various health conditions, with a pooled effect size indicating minimal benefit.

However, placebo interventions showed some influence on patient-reported outcomes, particularly for pain and nausea, although the effects varied widely and were often difficult to separate from reporting biases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo interventions for all clinical conditions. Hróbjartsson, A., Gøtzsche, PC.[2022]

Out of 2408 drug reports analyzed from the online platform mijnmedicijn.nl, 3.9% reported sexual adverse events (sAEs), with a notable prevalence among antidepressants, hormonal contraceptives, and medications for benign prostatic hyperplasia.

Women reported sAEs in 3.5% of their total reports, while men reported them in 4.7%, indicating a significant gender difference in reporting, particularly for antidepressants which had high reporting odds ratios (ROR) of 4.2 for women and 7.5 for men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient reporting of sexual adverse events on an online platform for medication experiences. Gordijn, R., Wessels, W., Kriek, E., et al.[2023]

Citations

1. 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 ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5960024/

Evaluation and Management of Hypoactive Sexual Desire ... To review the diagnosis and evidence-based treatment of low sexual desire in women with a focus on strategies that can be used efficiently and effectively in ...

4. dl.acm.org dl.acm.org/doi/full/10.1145/3715336.3735747

Approaching Pleasure as a Process when Designing with ... To inform our design inquiry, we conducted a qualitative survey (N=143) to generate how individuals understand and experience sexual pleasure.

5. opa.hhs.gov opa.hhs.gov/sites/default/files/2025-05/gender-dysphoria-report.pdf

Treatment for Pediatric Gender Dysphoria There is a lack of published research regarding sexual function outcomes in females who underwent PMT with PBs followed by CSH. 7.4 Cross ...

6. 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.

7. fda.gov fda.gov/files/news%20%26%20events%20/published/OCE-hemophilia-workshop-12.6.2019-transcript-condensed.pdf

Product Development in Hemophilia December 6, 2018 A Matter ... ... Product Development in Hemophilia. December 6, 2018. Page 1. Page 3. 1. FOOD AND DRUG ADMINISTRATION. 1. C O N T E N T S (continued). 2. ONCOLOGY CENTER OF ...

8. publications.ersnet.org publications.ersnet.org/content/erj/50/3/1602449/DC1/embed/inline-supplementary-material-1.pdf

Randomized Placebo-‐controlled Safety and Tolerability Trial o Online-‐data Supplement: Randomized Placebo-‐controlled Safety and Tolerability Trial of FK506 for Pulmonary Arterial. Hypertension.