Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
Study NCT ID:
NCT03761628
Status:
COMPLETED
Last Update Posted:
2025-07-25
First Post:
2018-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Performance of a Vaginal Pessary (pHyph) in Vulvovaginal Candidiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002181', 'term': 'Candidiasis, Vulvovaginal'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014848', 'term': 'Vulvovaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}], 'ancestors': [{'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014847', 'term': 'Vulvitis'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'annette.safholm@gedeabiotech.com', 'phone': '0046 708 91 86 81', 'title': 'Annette Säfholm, CEO', 'organization': 'Gedea Biotech AB'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to day 42', 'eventGroups': [{'id': 'EG000', 'title': 'pHyph, Gedea Pessary', 'description': 'Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of VVC.\n\npHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of VVC', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 12, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Cure Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'pHyph, Gedea Pessary', 'description': 'Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of VVC.\n\npHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of VVC'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Clinical cure rate', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '40.9', 'ciLowerLimit': '23.3', 'groupDescription': 'It was assumed that the true cure rate was equal to 70%, therefore 22 patients were needed to obtain 90% chance (90% power) to show that the one-sided 95% CI for the observed cure rate was above 40%.\n\nHypotheses for the primary clinical performance endpoint:\n\n* Null hypothesis: Clinical cure rate is less than or equal to 40%.\n* Alternative hypothesis (one-sided): Clinical cure rate is above 40%.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The clinical performance endpoint - Clinical cure rate on Day 7 - was calculated and presented together with a one-sided 95% CI based on the exact binomial distribution (Clopper-Pearson).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7', 'description': 'Clinical cure was defined as the absence of signs and symptoms of vulvovaginal candidiasis (VVC) in terms of having a composite vulvovaginal signs-and-symptoms (CVVS) score equal to or below 3.\n\n* Each of the following 6 vulvovaginal signs and symptoms were individually scored using the scoring scale below and then added together to determine the CVVS score.\n\n * Vulvovaginal signs: erythema, edema, or excoriation\n * Vulvovaginal symptoms: itching, burning, or irritation\n* Scoring Scale: each score should be objectively defined. 0 = none (absent)\n\n 1. = mild (slight)\n 2. = moderate (definitely present)\n 3. = severe (marked, intense)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full analysis set population contained 23 patients. One patient was not included in this analysis due to missing clinical cure data (CVVS score).'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Having a Reduction in CVVS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'pHyph, Gedea Pessary', 'description': 'Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of VVC.\n\npHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of VVC'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Proportion with reduction', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '72.7', 'ciLowerLimit': '49.8', 'ciUpperLimit': '89.3', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Results are based on the exact binomial distribution (Clopper-Pearson).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7 compared to Day 0', 'description': 'Defined as the absence of signs and symptoms of vulvovaginal candidiasis (VVC) in terms of having a composite vulvovaginal signs-and-symptoms (CVVS) score equal to or below 3.\n\n\\- Each of the following 6 vulvovaginal signs and symptoms were individually scored using the scoring scale below and then added together to determine the CVVS score.\n\n* Vulvovaginal signs: erythema, edema, or excoriation\n* Vulvovaginal symptoms: itching, burning, or irritation -Scoring Scale: each score should be objectively defined: 0 = none (absent)\n\n 1. = mild (slight)\n 2. = moderate (definitely present)\n 3. = severe (marked, intense)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full analysis set population contained 23 patients. One patient was not included in this analysis due to missing clinical cure data (CVVS score).'}, {'type': 'SECONDARY', 'title': 'Usability, Measured by Patient Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'pHyph, Gedea Pessary', 'description': 'Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of VVC.\n\npHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of VVC'}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '2.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7', 'description': 'General assessment of the treatment on a integer scale that ranges from 1 to 10. The lower end of the scale is indicated with the term "Not satisfied" and the higher end with the term "Very satisfied".\n\nQuestion asked: How do you generally regard the treatment?', 'unitOfMeasure': 'Integer scale (1-10)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full analysis set population contained 23 patients. One patient was not included in this analysis due to missing clinical cure data (CVVS score).'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Having a Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'pHyph, Gedea Pessary', 'description': 'Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of VVC.\n\npHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of VVC'}], 'classes': [{'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Recurrence rate Day 14', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.5', 'ciLowerLimit': '0.3', 'ciUpperLimit': '52.7', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Results are based on the exact binomial distribution (Clopper-Pearson).'}, {'groupIds': ['OG000'], 'paramType': 'Recurrence rate Day 35', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '45.9', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Results are based on the exact binomial distribution (Clopper-Pearson).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to day 35', 'description': 'Proportion of patients answering \\[Yes\\] to the question "Have the symptoms recurred?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full analysis set population contained 23 patients.The sub-set of the Full analysis set including patients not receiving prolonged treatment contained 9 patients. Of these, 8 patients were included in this analysis of recurrence at Day 14 and 6 patients were included in the analysis of recurrence at Day 35.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'pHyph, Gedea Pessary', 'description': 'Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of VVC.\n\npHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of VVC'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Received study treatment', 'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'pHyph, Gedea Pessary', 'description': 'Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of vulvovaginal candidiasis (VVC).\n\npHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of VVC'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29.9', 'spread': '8.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Experience of any vaginal candida infection during the last 12 months', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'A total of 24 participants were enrolled, whereof 23 participants received study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-24', 'size': 1004057, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-08T09:30', 'hasProtocol': True}, {'date': '2020-01-14', 'size': 669218, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-08T09:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2018-11-29', 'resultsFirstSubmitDate': '2025-07-08', 'studyFirstSubmitQcDate': '2018-11-30', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-08', 'studyFirstPostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Cure Rate', 'timeFrame': 'Day 7', 'description': 'Clinical cure was defined as the absence of signs and symptoms of vulvovaginal candidiasis (VVC) in terms of having a composite vulvovaginal signs-and-symptoms (CVVS) score equal to or below 3.\n\n* Each of the following 6 vulvovaginal signs and symptoms were individually scored using the scoring scale below and then added together to determine the CVVS score.\n\n * Vulvovaginal signs: erythema, edema, or excoriation\n * Vulvovaginal symptoms: itching, burning, or irritation\n* Scoring Scale: each score should be objectively defined. 0 = none (absent)\n\n 1. = mild (slight)\n 2. = moderate (definitely present)\n 3. = severe (marked, intense)'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients Having a Reduction in CVVS Score', 'timeFrame': 'Day 7 compared to Day 0', 'description': 'Defined as the absence of signs and symptoms of vulvovaginal candidiasis (VVC) in terms of having a composite vulvovaginal signs-and-symptoms (CVVS) score equal to or below 3.\n\n\\- Each of the following 6 vulvovaginal signs and symptoms were individually scored using the scoring scale below and then added together to determine the CVVS score.\n\n* Vulvovaginal signs: erythema, edema, or excoriation\n* Vulvovaginal symptoms: itching, burning, or irritation -Scoring Scale: each score should be objectively defined: 0 = none (absent)\n\n 1. = mild (slight)\n 2. = moderate (definitely present)\n 3. = severe (marked, intense)'}, {'measure': 'Usability, Measured by Patient Questionnaire', 'timeFrame': 'Day 7', 'description': 'General assessment of the treatment on a integer scale that ranges from 1 to 10. The lower end of the scale is indicated with the term "Not satisfied" and the higher end with the term "Very satisfied".\n\nQuestion asked: How do you generally regard the treatment?'}, {'measure': 'Proportion of Patients Having a Recurrence', 'timeFrame': 'Up to day 35', 'description': 'Proportion of patients answering \\[Yes\\] to the question "Have the symptoms recurred?"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaginal Yeast Infection', 'Candidiasis, vulvovaginal', 'Genital diseases, female', 'Vaginitis', 'Vulvovaginitis', 'Vaginal diseases'], 'conditions': ['Vulvovaginal Candidiasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://gedeabiotech.com', 'label': 'Sponsor webpage'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with vulvovaginal candidias (VVC). On Day 0, patients will have gynecological examination, vaginal samples taken, and will receive the investigational product to be self-administered. Patients will be examined after 7 days with respect to VVC signs and symptoms and if not cured, will receive prolonged treatment for one additional week. Patients will be followed-up by telephone up to 29 days after last treatment. Vaginal samples will be used for confirming diagnosis and microbiome analyzes. Patient questionnaires will be used for assessing VVC symptoms, usability, and adverse events (AEs).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult, post-menarchal, pre-menopausal women aged 18 years or older\n* Diagnosis of VVC, defined as having a white or creamy vaginal discharge plus the following findings:\n\n 1. At least 2 of the following signs and symptoms of VVC that are characterized as at least moderate: itching, burning, irritation, edema, redness, or excoriation.\n 2. Potassium hydroxide (KOH) or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts.\n* Having decisional capacity and providing written informed consent\n* Negative urine pregnancy test at screening\n* Refrain from using any intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) during the study period\n* Refrain from sexual intercourse or use a condom until Day 7\n* Signed informed consent and willing and able to comply with all study requirements\n\nExclusion Criteria:\n\n* Patients with known or apparent signs of other infectious causes of VVC (BV, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at screening\n* Patients who are pregnant or breastfeeding\n* Patients who were treated for VVC within the past 14 days\n* Patients who are currently receiving antifungal therapy unrelated to VVC or has taken antifungal therapy within the past 14 days\n* Patients who have used pH-modifying vaginal products within the last 14 days\n* Patients who have received an investigational drug in a clinical investigation within 30 days prior to screening\n* Known/previous allergy or hypersensitivity to any product constituent or fluconazole\n* Any medical condition that in the Investigator's judgments would make the patient unsuitable for inclusion"}, 'identificationModule': {'nctId': 'NCT03761628', 'briefTitle': 'Clinical Performance of a Vaginal Pessary (pHyph) in Vulvovaginal Candidiasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gedea Biotech AB'}, 'officialTitle': 'An Open-label Study to Evaluate Clinical Performance of Gedea Pessary in Adult Women With Vulvovaginal Candidiasis', 'orgStudyIdInfo': {'id': 'QRS-CL1-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pHyph, Gedea Pessary', 'description': 'Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of VVC.', 'interventionNames': ['Device: pHyph generation I']}], 'interventions': [{'name': 'pHyph generation I', 'type': 'DEVICE', 'otherNames': ['Gedea pessary'], 'description': 'A vaginal tablet for the treatment of VVC to be administered every 48 hours', 'armGroupLabels': ['pHyph, Gedea Pessary']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsingborg', 'country': 'Sweden', 'facility': 'Hoftekliniken', 'geoPoint': {'lat': 56.04673, 'lon': 12.69437}}, {'city': 'Hofterup', 'country': 'Sweden', 'facility': 'Annerokliniken', 'geoPoint': {'lat': 55.80485, 'lon': 12.9797}}], 'overallOfficials': [{'name': 'Monika Cardell, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kvinnokliniken, Region Skåne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gedea Biotech AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}