[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657306":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":60,"studyPopulation":53,"armGroups":61,"interventions":83,"overallOfficials":98,"centralContacts":102,"locations":111,"responsibleParty":130,"collaborators":53,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":53,"eligibilityCriteria":138,"healthyVolunteers":139,"sex":140,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":53,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":53,"overallStatus":151,"whyStopped":53,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Radicle Science","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"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.","13 weeks",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":12},"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)",{"measure":24,"description":25,"timeFrame":12},"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)",{"measure":27,"description":28,"timeFrame":12},"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)",[30,33,36,39,42,45],{"measure":31,"description":32,"timeFrame":12},"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)",{"measure":34,"description":35,"timeFrame":12},"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)",{"measure":37,"description":38,"timeFrame":12},"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)",{"measure":40,"description":41,"timeFrame":12},"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)",{"measure":43,"description":44,"timeFrame":12},"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)",{"measure":46,"description":47,"timeFrame":12},"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)",{"allocation":49,"interventionModel":50,"interventionModelDescription":51,"primaryPurpose":52,"observationalModel":53,"timePerspective":53,"maskingInfo":54},"RANDOMIZED","PARALLEL","Eligible participants must complete all enrollment requirements before stratification and randomization. Participants will be stratified using three factors: biospecimen collection participation (yes or no), age (21-44, 45-64, or 65+ years), and diary score for Item 1 (1-3 or 4-5). These factors will be used collectively to support balanced sequential randomization across study product groups. Following randomization, participants will receive their assigned study product along with an informational insert containing instructions for product use and additional study procedures.","OTHER",null,{"masking":55,"maskingDescription":56,"whoMasked":57},"DOUBLE","The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.",[58,59],"PARTICIPANT","INVESTIGATOR","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.",[62,68,73,77],{"label":63,"type":64,"description":65,"interventionNames":66},"Active Product 1","EXPERIMENTAL","Active Sexual Health Product 1",[67],"Dietary Supplement: Active Sexual Health Product 1",{"label":69,"type":64,"description":70,"interventionNames":71},"Active Product 2","Active Sexual Health Product 2",[72],"Dietary Supplement: Active Sexual Health Product 2",{"label":74,"type":64,"description":65,"interventionNames":75},"Active Product 3",[76],"Dietary Supplement: Active Sexual Health Product 3",{"label":78,"type":79,"description":80,"interventionNames":81},"Placebo Control","PLACEBO_COMPARATOR","Placebo Sexual Health Control Product",[82],"Dietary Supplement: Placebo Sexual Health Control Product",[84,88,91,95],{"type":85,"name":65,"description":86,"armGroupLabels":87,"otherNames":53},"DIETARY_SUPPLEMENT","Participants will use their Active Sexual Health Product 1 as directed for a period of 12 weeks",[63],{"type":85,"name":70,"description":89,"armGroupLabels":90,"otherNames":53},"Participants will use their Active Sexual Health Product 2 as directed for a period of 12 weeks",[69],{"type":85,"name":92,"description":93,"armGroupLabels":94,"otherNames":53},"Active Sexual Health Product 3","Participants will use their Active Sexual Health Product 3 as directed for a period of 12 weeks",[74],{"type":85,"name":80,"description":96,"armGroupLabels":97,"otherNames":53},"Participants will use their Placebo Sexual Health Control Product as directed for a period of 12 weeks",[78],[99],{"name":100,"affiliation":5,"role":101},"Susan Hewlings","PRINCIPAL_INVESTIGATOR",[103,108],{"name":104,"role":105,"phone":106,"phoneExt":53,"email":107},"Study Manager","CONTACT","858-779-0086","studymgmt@radiclescience.com",{"name":100,"role":105,"phone":109,"phoneExt":53,"email":110},"760-281-3898","susan.hewlings@radiclescience.com",[112],{"facility":113,"status":53,"city":114,"state":115,"zip":116,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":124,"contacts":125},"Radicle Science Inc.","Del Mar","California","92014","United States","US",{"type":120,"coordinates":121},"Point",[122,123],-117.26531,32.95949,{"lat":123,"lon":122},[126,127],{"name":104,"role":105,"phone":109,"phoneExt":53,"email":107},{"name":128,"role":105,"phone":53,"phoneExt":53,"email":129},"Megan Moseley","megan@radiclescience.com",{"type":131,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR","100657306","radicle-womens-sexual-healthtm-cix-a-study-assessing-the-impact-of-health-and-wellness-products-on-sexual-health-and-related-health-outcomes-100657306",false,"NCT07835763","Radicle Women's Sexual HealthTM CIX: A Study Assessing the Impact of Health and Wellness Products on Sexual Health and Related Health Outcomes","Radicle Women's Sexual HealthTM 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","3.1 Inclusion\n\nParticipants must meet all the following criteria:\n\n* Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities\n\n  * Assigned sex at birth is female\n* Resides in the United States\n* Has the opportunity for at least 30% improvement in their primary health outcome\n* Has the opportunity and desire to regularly engage in sexual activity over the next 12 weeks\n* Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study\n\n3.2 Exclusion\n\nIndividuals who report any of the following during screening may be excluded from participation:\n\n* Report being pregnant, trying to become pregnant, or breastfeeding\n* Unable to provide a valid US shipping address and mobile phone number\n* Reports current enrollment in another clinical trial\n* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)\n* Unable to read and understand English at a 7th grade level\n* Reports a current and\u002For recent (up to 3 months ago) major illness and\u002For surgery that poses a known, significant safety risk.\n* Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and\u002For a significant safety risk with any of the study product ingredients.\n\n  * NYHA 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\n* Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.\n\n  * Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids 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\n* Reports current use of the primary ingredient(s) and\u002For similar product(s) to the active study product(s) that may limit the effects of the study products and\u002For pose a safety risk\n* Lack of reliable daily access to the internet\n* 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.\n\n  * 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.",true,"FEMALE","21 Years","105 Years",{"count":144,"type":145},1100,"ESTIMATED","INTERVENTIONAL",[148],"NA","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.",[10],"NOT_YET_RECRUITING","2026-09-17",{"date":154,"type":155},"2026-09-23","ACTUAL",{"date":157,"type":145},"2026-09-03",{"date":159,"type":145},"2027-09-03",{"name":5,"class":6},1]