Radicle Spark for Women™ 24: Assessing the Impact of Health and Wellness Products on Sexual Health and Related Health Outcomes

Last updated: March 17, 2025
Sponsor: Radicle Science
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Spark Placebo Control 5.1

Spark Active Study Product 5.1 Usage

Clinical Study ID

NCT06891547
RADX-P-2410
  • Ages 21-105
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Inclusion

Inclusion Criteria:

  • Adults, at least 21 years of age at the time of electronic consent, inclusive of allethnicities, races, and gender identities - Assigned sex at birth is female

  • Resides in the United States

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

  • 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

Exclusion Criteria:

  • Report being pregnant, trying to become pregnant, or breastfeeding

  • Unable to provide a valid US shipping address and mobile phone number

  • Reports current enrollment in another clinical trial

  • Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages perday)

  • Unable to read and understand English

  • Reports a current and/or recent (up to 3 months ago) major illness and/or surgerythat poses a known, significant safety risk.

  • Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents aknown contraindication and/or a significant safety risk with any of the studyproduct ingredients. o NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolledarrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidneydisease, or kidney failure

  • Reports taking medications that have a well-established moderate or severeinteraction, posing a substantial safety risk with any of the study productingredients. o Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy,immunotherapy, sedative hypnotics, seizure medications, medications that warnagainst grapefruit consumption, corticosteroids at doses greater than 5 mg per day,diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) totreat an acute infection, antipsychotics, MAOIs, or thyroid products

  • Reports current use of the primary ingredient(s) and/or similar product(s) to theactive study product(s) that may limit the effects of the study products

  • Lack of reliable daily access to the internet

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Spark Placebo Control 5.1
Phase:
Study Start date:
February 20, 2025
Estimated Completion Date:
January 01, 2026

Study Description

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) endorse a desire for improved libido (sex drive), sexual satisfaction and/or function, (2) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study. Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded. Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Connect with a study center

  • Radicle Science, Inc

    Del Mar, California 92014
    United States

    Active - Recruiting

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