[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613779":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":31,"studyPopulation":23,"armGroups":32,"interventions":55,"overallOfficials":73,"centralContacts":77,"locations":83,"responsibleParty":101,"collaborators":23,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":23,"eligibilityCriteria":109,"healthyVolunteers":110,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":23,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":23,"overallStatus":86,"whyStopped":23,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"London Metropolitan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":23},[9,13,16,20],{"measure":10,"description":11,"timeFrame":12},"The Female Sexual Function Index","This is a 19 item measure of sexual pain, sexual desire, orgasm, lubrication, and sexual satisfaction with five response categories. The score range is 2.0 to 36.0 with 26.0 being the cut of for sexual dysfunction. Example questions include, Over the past 4 weeks, how often did you experience discomfort or pain during vaginal penetration? and Over the past 4 weeks, how would you rate your level of discomfort or pain during or following vaginal penetration? Cronbach alpha for this questionnaire is .820 and higher.","0, 4 and 12 weeks",{"measure":14,"description":15,"timeFrame":12},"The Short Warwick Edinburgh Mental Well-being Scale","This is a 7 item questionnaire with 5 response categories looking at functioning and feeling aspects of well-being. The response categories include 1=none of the time to 5=all of the time. Cronbach alpha for the questionnaire is 0.89-0.91. There is no reverse scoring. Scores range from 7 to 35 where the latter is the highest level of wellbeing.",{"measure":17,"description":18,"timeFrame":19},"Brief Quality of Life Scale","An 8 item questionnaire with five response categories looking at satisfaction with self, friends, family and creativity. This scale is scored by transforming the individual item scores from a 1 to 5 scale to a 0 to 100 scale. Example responses include how I view my life as necessary for my quality of life, and I am satisfied with my friends and friendship: The Cronbach alpha is .760 for this questionnaire","Weeks 0, 4 and 12",{"measure":21,"description":22,"timeFrame":19},"Changes in levels of anal pain taken","The frequency and severity of pain during anal sex, this is a 5-point Likert-type scale which ranges from never (5) to all the time (1) and no anal pain (5) to severe anal pain (1). The Cronbach alpha in this study= 0.70.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":27,"primaryPurpose":28,"observationalModel":23,"timePerspective":23,"maskingInfo":29},"RANDOMIZED","PARALLEL","The study phase is not applicable, as cannabidiol suppositories are not considered a drug.\n\nRandomisation would be based on dose specific groups, including, for example, 30, 50, 100mg and care as usual group.","TREATMENT",{"masking":30,"maskingDescription":23,"whoMasked":23},"NONE","Sexual pain is a constellation of biopsychosocial disorders which affects men, women and their partners.\n\nCannabidiol is one of approximately 100 cannabinoids found in cannabis, alongside tetrahydrocannabinol. Cannabidiol is non-intoxicating and regarded as a safe product to use. Cannabidiol has many applications, including in sexual health. Two studies have examined cannabidiol suppositories for supporting sexual function and reducing sexual pain. In both studies, outcomes suggested the pain relieving qualities of cannabidiol oil for both men and women.\n\nThis research aims to establish the effectiveness of varied doses of cannabidiol oil to minimise sexual pain and increase well-being. This research is a preliminary study looking at how cannabidiol suppositories aim to reduce pain and support sexual function, wellbeing and quality of life among those experiencing sexual discomfort or pain during intercourse or masturbation.\n\nThere will be four groups, where cannabidiol will be randomised to dose-specific groups, approximately 30, 50, and 100mg, under the guidance of a medical practitioner. There will also be a care as usual group.\n\nIt is hypothesised that:\n\nHigher levels of sexual functioning, quality of life and wellbeing with lower levels of sexual pain will be reported among those using cannabidiol suppositories at the follow-up after intervention compared to care as usual group.\n\nIt is further hypothesised that higher doses of cannabidiol suppositories will have higher levels of sexual pain-reducing outcomes.",[33,39,44,49],{"label":34,"type":35,"description":36,"interventionNames":37},"Cannabidiol 30mg","EXPERIMENTAL","This will be a dose specific suppository of 30mg, which will be used for one month. Frequency will depend on how often the participant engages in sexual intimacy.",[38],"Dietary Supplement: Cannabidiol suppository intervention 1",{"label":40,"type":35,"description":41,"interventionNames":42},"Cannabidiol 50mg","This will be a dose specific suppository of 50mg, which will be used for one month. Frequency will depend on how often the participant engages in sexual intimacy.",[43],"Dietary Supplement: Cannabidiol suppository intervention 2",{"label":45,"type":35,"description":46,"interventionNames":47},"Cannabidiol 100mg","This will be a dose specific suppository of 100mg, which will be used for one month. Frequency will depend on how often the participant engages in sexual intimacy.",[48],"Dietary Supplement: Cannabidiol suppository intervention 3",{"label":50,"type":51,"description":52,"interventionNames":53},"Care as usual","ACTIVE_COMPARATOR","This is the care as usual group, which will be the control for comparative outcomes with sexual function, sexual pain, well being and quality of life.",[54],"Other: Non cannabidiol group control",[56,61,65,69],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":23},"DIETARY_SUPPLEMENT","Cannabidiol suppository intervention 1","Cannabidiol suppository dose specific 30mg",[34],{"type":57,"name":62,"description":63,"armGroupLabels":64,"otherNames":23},"Cannabidiol suppository intervention 2","Cannabidiol suppository dose specific 50mg",[40],{"type":57,"name":66,"description":67,"armGroupLabels":68,"otherNames":23},"Cannabidiol suppository intervention 3","Cannabidiol suppository dose specific 100mg",[45],{"type":6,"name":70,"description":71,"armGroupLabels":72,"otherNames":23},"Non cannabidiol group control","Care as usual group",[50],[74],{"name":75,"affiliation":5,"role":76},"Samantha Banbury","PRINCIPAL_INVESTIGATOR",[78],{"name":79,"role":80,"phone":81,"phoneExt":23,"email":82},"Anna Kamyk","CONTACT","02074230000","rpo@londonmet.ac.uk",[84],{"facility":85,"status":86,"city":87,"state":23,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"School of Social Sciences and Professions","RECRUITING","London","N7 8DB","United Kingdom","UK",{"type":92,"coordinates":93},"Point",[94,95],-0.12574,51.50853,{"lat":95,"lon":94},[98],{"name":99,"role":80,"phone":23,"phoneExt":23,"email":100},"Samantha Banbury, PhD","s.banbury1@londonmet.ac.uk",{"type":102,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100613779","the-use-of-cannabidiol-suppositories-for-sexual-pain-100613779",false,"NCT07271030","The Use of Cannabidiol Suppositories for Sexual Pain","The Use of Cannabidiol Suppositories for Sexual Pain: A Randomised Controlled Study","Inclusion Criteria:\n\n* Has previously used cannabidiol in any capacity and has not experienced any allergic reaction\n* Is experiencing sexual pain\n* There will be an absence of co occurring difficulties\n* Has attempted sexual intercourse in the last month\n* Age 18 years or older\n* Read and write English\n* Patient Health Questionnaire 9 screening score range between 0-9 mild\n* General Anxiety Disorder 7 screening score range between 0-9 mild\n* There are no restrictions on sex, gender, sexuality, or disability\n\nExclusion Criteria:\n\nHas experienced an allergic reaction to cannabidiol in any capacity\n\n* Has not attempted sexual intercourse in the last month\n* Has co occurring difficulties\n* Aged below 18 years old\n* Are not experiencing sexual pain\n* Patient Health Questionnaire 9 screening score range between moderate to severe - 10-27\n* General Anxiety Disorder 7 screening score range between 10- 21.",true,"ALL","18 Years","100 Years",{"count":115,"type":116},50,"ESTIMATED","INTERVENTIONAL",[119],"NA","Research aim: To determine how cannabidiol suppositories might reduce sexual pain during intimacy. Outcomes are also hoped to increase sexual functioning, well-being, and quality of life.\n\nResearch intention: If cannabidiol suppository intervention reduces sexual pain and increases general well-being, then this research would be repeated on a larger scale, targeting psychosexual services.\n\nA brief overview of the intervention:\n\nQuantitatively, randomisation of cannabidiol suppositories will be into dose-specific groups. The intervention will be delivered over a period of one month, with follow-up scheduled at 12 weeks. Qualitatively, participants were asked approximately eight open-ended feedback questions throughout the study.",[122,123,124,125],"Well-Being, Psychological","Quality of Life","Sexual Behavior","Sexual Pain Disorder","2026-08-24",{"date":128,"type":129},"2026-08-25","ACTUAL",{"date":131,"type":129},"2026-01-16",{"date":133,"type":116},"2027-12",{"name":5,"class":6},1]