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

600 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Spark Active Study Product 5.1 for sexual satisfaction?

The research suggests that placebo interventions can have beneficial effects on patient-reported outcomes, especially in areas like pain, which might indirectly support the potential effectiveness of Spark Active Study Product 5.1 if it leverages similar mechanisms. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The research does not provide specific safety data for Spark Active Study Product 5.1 or Spark Placebo Control 5.1, but it highlights the need for rigorous research and product control to address safety questions for herbal agents used in sexual health. ^{6 7 8 9 10}

How does the Spark Active Study Product 5.1 treatment differ from other treatments 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 satisfaction, which may involve novel ingredients or formulations not typically found in standard treatments. Unlike conventional medical treatments, this study may explore alternative or herbal approaches, similar to those discussed in research on plant-derived remedies for sexual dysfunctions. ^{7 8 9 10 11}

What is the purpose of this trial?

A randomized, double-blind, placebo-controlled, direct-to-consumer study assessing the impact of health and wellness products on sexual health and related health outcomes.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Placebo interventions for all clinical conditions. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A transferable anxiolytic placebo effect from noise to negative effect. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The nature and power of the placebo effect. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

The quantification of placebo effects within a general model of health care outcomes. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Patient reporting of sexual adverse events on an online platform for medication experiences. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A review of plant-derived and herbal approaches to the treatment of sexual dysfunctions. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Flibanserin for Hypoactive Sexual Desire Disorder: An Open-Label Safety Study. [2019]

9. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of the safety and efficacy of wormwood vaginal gel in improving sexual function and sexual satisfaction in women of reproductive age: A randomized, triple-blinds, placebo-controlled clinical trial. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Kyo-Green improves sexual dysfunction in men and women. [2015]

11. England pubmed.ncbi.nlm.nih.gov

Effect of a multi-ingredient based food supplement on sexual function in women with low sexual desire. [2021]