Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-28 @ 5:06 PM
Study NCT ID:
NCT06237166
Status:
COMPLETED
Last Update Posted:
2025-08-22
First Post:
2024-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of an Online Intervention for Female Sexual Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2024-01-24', 'studyFirstSubmitQcDate': '2024-01-24', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cognitions and behaviors related to sexual pain', 'timeFrame': '3 months, 6 months', 'description': 'Self-compiled instrument assessing cognitions and behaviors related to sexual pain. Total score ranging from 0-100; higher scores mean more maladaptive cognitions and behaviors related to sexual pain (worse outcome).'}], 'primaryOutcomes': [{'measure': 'sexual functioning', 'timeFrame': '3 months', 'description': 'Female Sexual Function Index (FSFI). Total score ranging from 2-36; higher scores mean better sexual function (better outcome).'}], 'secondaryOutcomes': [{'measure': 'Depressive symptoms', 'timeFrame': '3 months, 6 months', 'description': 'Patient Health Questionnaire - 9 item version (PHQ-9). Total score ranging from 0-27; higher scores mean more depressive symptomatology (worse outcome).'}, {'measure': 'Sexual desire', 'timeFrame': '3 months, 6 months', 'description': 'Sexual Interest and Desire Inventory - Female - Self-Report (SIDI-F-SR). Total score ranging from 0-51; higher scores mean higher levels of sexual desire (better outcome).'}, {'measure': 'Sexual satisfaction', 'timeFrame': '3 months, 6 months', 'description': 'New Sexual Satisfaction Scale - Short Form (NSS-SF). Total score ranging from 12 to 60; higher scores mean higher sexual satisfaction.'}, {'measure': 'Sexual functioning', 'timeFrame': '6 months', 'description': 'Female Sexual Function Index (FSFI). Total score ranging from 2-36; higher scores mean better sexual function (better outcome).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Female Sexual Dysfunction']}, 'descriptionModule': {'briefSummary': 'In this randomized controlled clinical trial, 250 participants with female sexual dysfunction will be investigated regarding the effectiveness of an online intervention for improving sexual function, the unguided online intervention mylovia. Inclusion criteria are: female sex and female gender, age ≥18, diagnosed sexual dysfunction (ICD-11: HA00, HA01, HA02) or sexual pain disorder (ICD-11: HA20), low sexual functioning (\\<27 on the Female Sexual Function Index; FSFI), sufficient German skills, and consent to participation. Exclusion criteria are: biological, psychological or social factors that might interfere with study participation, and use of another digital intervention for sexual problems. Participants will be randomized and allocated to either an intervention group, receiving access to mylovia in addition to treatment as usual (TAU), or a control group, receiving information material about treatment and counseling options in addition to TAU. Primary endpoint will be sexual functioning assessed via FSFI, with three months post-allocation being the primary time point for assessment of effectiveness. Six months post allocation will be used as a timepoint for follow-up assessment of endpoints. Secondary endpoints will be sexual desire, sexual satisfaction, sexual pain, and general psychopathology.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'both female sex and female gender', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* female sex\n* female gender\n* age ≥ 18 years\n* diagnosis of sexual dysfunction (ICD-11: HA00, HA01, HA02) or sexual pain disorder (ICD-11: HA20), diagnosed via the DISEX-F interview\n* Sexual function score (cut-off) of \\<27 on the FSFI\n* consent to participation\n* sufficient knowledge of the German language\n\nExclusion Criteria:\n\n* Use of another digital intervention for sexual problems\n\nIn general, given that sexual dysfunction is a biopsychosocial phenomenon, mylovia is hypothesized to help women irrespective of the disorder's etiology (i.e., biological, psychological, or social). However, if one of the domains is extremely compromised, mylovia might not be expedient. Therefore, a clinical assessment of factors that might interfere with study assessment will be conducted, with the following additional exclusion criteria:\n\n* Biological factors that might interfere with study participation (e.g., cancer, multiple sclerosis)\n* Psychological factors that might interfere with study participation (e.g., schizophrenia, bipolar disorder, borderline personality disorder, eating disorder, post-traumatic stress disorder, severe depression, suicidality, substance use disorder)\n* Social factors that might interfere with study participation (e.g. severe partnership problems)"}, 'identificationModule': {'nctId': 'NCT06237166', 'acronym': 'FELYCIA', 'briefTitle': 'Evaluation of an Online Intervention for Female Sexual Dysfunction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gaia AG'}, 'officialTitle': 'Evaluation of an Online Intervention for Female Sexual Dysfunction: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'mylovia RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mylovia + TAU', 'description': 'Participants allocated to the intervention group will receive access to mylovia in addition to treatment as usual (TAU).\n\nmylovia is a digital health application designed for women with sexual dysfunction, accessible through a web browser. The application focuses on treatment methods derived from cognitive behavioral therapy (CBT). Topics addressed by mylovia are psychoeducation, relaxation and mindfulness exercises, strategies to improve self-esteem, development of passionate attitudes and situations, dealing with differences in desire in a relationship, and sensate focus exercises.\n\nThe program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivational text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 180 days.', 'interventionNames': ['Behavioral: mylovia']}, {'type': 'NO_INTERVENTION', 'label': 'information material + TAU', 'description': 'Participants allocated to the control group will receive access to information material about treatment and counseling options in addition to treatment as usual (TAU).'}], 'interventions': [{'name': 'mylovia', 'type': 'BEHAVIORAL', 'description': 'Participants will receive access to the digital health intervention mylovia in addition to TAU.', 'armGroupLabels': ['mylovia + TAU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22085', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'GAIA', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Johanna Schröder, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical School Hamburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaia AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medical School Hamburg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}