ClinicalTrials.gg
Not yet recruitingNCT07835763Updated Sep 23, 2026

Radicle Women's Sexual HealthTM CIX: A Study Assessing the Impact of Health and Wellness Products on Sexual Health and Related Health Outcomes

An interventional study of Active Sexual Health Product 1 and Active Sexual Health Product 2 in Sexual Desire, sponsored by Radicle Science. Not yet recruiting at 1 site in United States. Open to female participants aged 21 Years to 105 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Radicle Science · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
1,100
Allocation
Randomized
Ages
21 Years to 105 Years
Sex
Female
01

Study summary

Radicle Women's Sexual Health™ CIX: 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.

Read the detailed description

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants are (1) female, (2) experience issues with sexual desire, (3) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (2) express acceptance in taking a product and not knowing its formulation until the end of the study. 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 13 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

02

Conditions studied

  • Sexual Desire
03

In context

Lead sponsor

Radicle Science is the lead sponsor of 66 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 105 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Participants must meet all the following criteria:

  • Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities

    • Assigned sex at birth is female
  • Resides in the United States
  • Has the opportunity for at least 30% improvement in their primary health outcome
  • Has the opportunity and desire to regularly engage in sexual activity over the next 12 weeks
  • 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

3.2 Exclusion

Individuals who report any of the following during screening may be excluded from participation:

  • 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 per day)
  • Unable to read and understand English at a 7th grade level
  • Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
  • Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known and/or a significant safety risk with any of the study product ingredients.

    • Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
  • Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.

    • Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products
  • Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products and/or pose a safety risk
  • Lack of reliable daily access to the internet
  • Participants residing in the states of New York, New Jersey, or Rhode Island are eligible to enroll in the main study and will complete all primary study activities. However, these participants are not eligible to participate in the biomarker collection. This restriction is due to state regulatory requirements governing direct-to-consumer at-home laboratory specimen collection and processing that cannot be accommodated within the fully decentralized design of the biomarker collection. No alternative collection pathway is available under the current protocol.

    • To ensure compliance, state-of-residence logic is built into the enrollment platform. Participants who indicate a residential address in New York, New Jersey, or Rhode Island will not be presented with the biomarker collection consent or any associated study materials. This automated screening ensures that ineligible participants are not inadvertently enrolled in the collection. These participants will otherwise proceed through full main study enrollment and participation without interruption.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,100 participants (estimated)

Study arms

  • Experimental
    Active Product 1

    Active Sexual Health Product 1

    Dietary Supplement: Active Sexual Health Product 1

  • Experimental
    Active Product 2

    Active Sexual Health Product 2

    Dietary Supplement: Active Sexual Health Product 2

  • Experimental
    Active Product 3

    Active Sexual Health Product 1

    Dietary Supplement: Active Sexual Health Product 3

  • Placebo comparator
    Placebo Control

    Placebo Sexual Health Control Product

    Dietary Supplement: Placebo Sexual Health Control Product

Interventions

  • Dietary supplementActive Sexual Health Product 1

    Participants will use their Active Sexual Health Product 1 as directed for a period of 12 weeks

  • Dietary supplementActive Sexual Health Product 2

    Participants will use their Active Sexual Health Product 2 as directed for a period of 12 weeks

  • Dietary supplementActive Sexual Health Product 3

    Participants will use their Active Sexual Health Product 3 as directed for a period of 12 weeks

  • Dietary supplementPlacebo Sexual Health Control Product

    Participants will use their Placebo Sexual Health Control Product as directed for a period of 12 weeks

06

What researchers measure

Primary outcomes

  1. Sexual Desire

    Sexual desire assessed by a single self report item, indicating sexual desire in the past 7 days. Scale 1-7 with higher scores indication greater desire.

    Time frame: 13 weeks

Secondary outcomes

  1. Sexual activity frequency

    Sexual activity frequency assessed by a single self-report item, indicating frequency of sexual activity in the last 7 days. Numerical text box entry, with higher scores indicating greater frequency of sexual activity.

    Time frame: 13 weeks

  2. Sexual discomfort intensity

    Sexual discomfort intensity assessed by a single self-report item, indicating the intensity of discomfort during sexual activity in the past 7 days. Scale 1-7, with higher scores indicating greater sexual discomfort.

    Time frame: 13 weeks

  3. Change in feelings of stress

    Change in feelings of stress: Difference between rates of change over time in feelings of stress score as assessed Perceived Stress Scale 10 (PSS-10) (score 10-50; where lower scores correspond to less stress)

    Time frame: 13 weeks

  4. Change in sleep-related impairment

    Change in sleep-related impairment: Difference between rates of change over time in sleep score as assessed by PROMIS Sleep-Related Impairment 8a (score 8-40; where the higher scores correspond to worse sleep)

    Time frame: 13 weeks

  5. Change in mood (emotional distress-depression)

    Change in mood (emotional distress-depression): Difference in rates of change over time in emotional distress score as assessed by PROMIS Emotional Distress- Depression 8A (score 8-40; with higher scores corresponding to greater levels of emotional distress)

    Time frame: 13 weeks

Other outcomes

  1. Minimal clinically important difference (MCID) in mood (emotional distress-depression)

    Minimal clinically important difference (MCID) in mood (emotional distress-depression): Likelihood of experiencing minimal clinically important difference in mood score as assessed by PROMIS Emotional Distress- Depression 8A (score 8-40; with higher scores corresponding to greater levels of emotional distress)

    Time frame: 13 weeks

  2. Minimal clinically important difference (MCID) in sleep

    Minimal clinically important difference (MCID) in sleep: Likelihood of experiencing minimal clinically important difference in sleep score, as measured by PROMIS Sleep-Related Impairment 8a (score 8-40; where the higher scores correspond to worse sleep)

    Time frame: 13 weeks

  3. Minimal clinically important difference (MCID) in feelings of stress

    Minimal clinically important difference (MCID) in feelings of stress: Likelihood of experiencing minimal clinically important difference in feelings of stress as assessed by Perceived Stress Scale (PSS-10) (score 10-50; where lower scores correspond to less stress)

    Time frame: 13 weeks

  4. Minimal clinically important difference (MCID) in sexual desire

    Minimal clinically important difference (MCID) in sexual desire: Likelihood of experiencing minimal clinically important difference in sexual desire score as assessed by single self report item Sexual Desire (scale 1-7; where higher scores correspond to greater sexual desire)

    Time frame: 13 weeks

  5. Minimal clinically important difference (MCID) in sexual activity frequency

    Minimal clinically important difference (MCID) in sexual activity frequency: Likelihood of experiencing minimal clinically important difference in frequency of sexual activity as assessed by single self report item sexual activity (numerical; where higher scores correspond to higher sexual activity)

    Time frame: 13 weeks

  6. Minimal clinically important difference (MCID) in sexual discomfort intensity

    Minimal clinically important difference (MCID) in sexual discomfort intensity: Likelihood of experiencing minimal clinically important difference in intensity of sexual discomfort as assessed by single self report item sexual discomfort (scale 1-7; where higher scores correspond to greater sexual discomfort)

    Time frame: 13 weeks

07

Study locations

1 site
08

References and documents

Related links

Individual participant data

Plan to share: No — Data will not be shared with researchers outside of Radicle Collaborators on this study.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07835763
Lead sponsor
Radicle Science
Responsible party
Sponsor
First posted
Sep 23, 2026
Start date
Sep 3, 2026 (estimated)
Primary completion
Sep 3, 2027 (estimated)
Completion
Sep 3, 2027 (estimated)
Last update
Sep 23, 2026

Study contacts

Study Manager
Contact
studymgmt@radiclescience.com
858-779-0086
Susan Hewlings
Contact
susan.hewlings@radiclescience.com
760-281-3898
Susan Hewlings
principal investigator · Radicle Science

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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