Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 3:11 PM
Study NCT ID:
NCT05507333
Status:
COMPLETED
Last Update Posted:
2025-10-06
First Post:
2022-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Performance of the Gedea Pessary in Adult Women With 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': 'Adverse events were collected from the first administration of the Gedea Pessary until the end-of-investigation visit (e.g., 25 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Gedea Pessary', 'description': 'Gedea pessary administration\n\nGedea pessary: Daily administration of the Gedea pessary for 6 consecutive days', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 16, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vulvovaginal burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vulvovaginal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vulvovaginal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bacterial vaginosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vulvovaginal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Cure Rate at Day 7-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gedea Pessary', 'description': 'Gedea pessary administration\n\nGedea pessary: Daily administration of the Gedea pessary for 6 consecutive days'}], 'classes': [{'title': 'Clinical cure - No', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Clinical cure - Yes', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Proportion of clinically cured patients', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.4073', 'ciUpperLimit': '0.7909', 'estimateComment': 'The proportion of clinically cured patients at Day 7-14 was calculated and presented together with a two-sided 95% CI based on the Wilson score for the proportion of "Yes" with continuity correction.', 'groupDescription': 'It was assumed that the true clinical cure rate was 54% in the treatment group, therefore a sample size of 24 patients was needed to obtain 80% power to show that the one-sided 95% CI for the clinical cure rate was above 30%. A sample size of 26 was used to account for patients with missing data.\n\nHypotheses for the primary endpoint:\n\nNull hypothesis: Clinical cure rate is less than or equal to 30%.\n\nAlternative hypothesis (one-sided): Clinical cure rate is above 30%', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7-14', '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, with no intercurrent events (concomitant anti-fungal therapy or other treatments related to VVC due to lack of clinical performance prior to CVVS evaluation for the primary endpoint definition, treatment discontinuation due to lack of clinical performance, or rescue medication prior to CVVS evaluation for the primary endpoint definition).\n\nEach of the following vulvovaginal signs and symptoms was individually scored using the scoring scale below. The CVVS score is the sum of the 6 individual scores.\n\n* Vulvovaginal signs: erythema, edema, or excoriation\n* Vulvovaginal symptoms: itching, burning, or irritation\n\nScoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Continued Clinical Response to Treatment at Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gedea Pessary', 'description': 'Gedea pessary administration\n\npHyph generation II: Daily administration of the Gedea pessary during 6 days'}], 'classes': [{'title': 'Continued clinical response to treatment at Day 25 - Yes', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Continued clinical response to treatment at Day 25 - No', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Proportion with cont. clinical response', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.5366', 'ciUpperLimit': '0.9729', 'estimateComment': 'The proportion of participants with continued clinical response at Day 25 ("Yes") was calculated and presented together with a two-sided 95% CI. The CI was based on the Wilson score for the proportion of "Yes" with a continuity correction.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 25', 'description': 'Defined as the proportion of patients clinically cured on Day 7-14 and thereafter responding "no" to the yes/no question, "Have the symptoms recurred?" via telephone on Day 25.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Day 25 Per Protocol Analysis Set - the subset of patients in the Full Analysis Set for whom no protocol deviation judged to impact the Day 25 analyses was reported or identified.'}, {'type': 'SECONDARY', 'title': 'Combined Clinical and Mycological Cure at Day 7-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gedea Pessary', 'description': 'Gedea pessary administration\n\nGedea pessary: Daily administration of the Gedea pessary for 6 consecutive days'}], 'classes': [{'title': 'Clinical cure and mycological cure - No', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Clinical cure and mycological cure - Yes', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Proportion with clin and mycol. cure', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '0.2091', 'ciUpperLimit': '0.5927', 'estimateComment': 'The proportion of participants with clinical and mycological cure at Day 7-14 ("Yes") was calculated and presented with a 95% CI. The CI was based on the Wilson score for the proportion of participants with "Yes" with a continuity correction.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7-14', 'description': 'The proportion of patients reporting clinical cure Day 7-14 according to the primary endpoint and mycological cure (culture negative for growth of Candida species).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Mycological Cure at Day 7-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gedea Pessary', 'description': 'Gedea pessary administration\n\nGedea pessary: Daily administration of the Gedea pessary for 6 consecutive days'}], 'classes': [{'title': 'Mycological cure - No', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Mycological cure - Yes', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Proportion with mycological cure', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.3375', 'ciUpperLimit': '0.7286', 'estimateComment': 'The proportion of participants with mycological cure at Day 7-14 ("Yes") was calculated and presented with a 95% CI. The CI was based on the Wilson score for the proportion of participants with "Yes" with a continuity correction.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7-14', 'description': 'Defined as the proportion of patients having a mycological cure as assessed by vaginal culture at Day 7-14.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Mycological Cure at Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gedea Pessary', 'description': 'Gedea pessary administration\n\nGedea pessary: Daily administration of the Gedea pessary for 6 consecutive days'}], 'classes': [{'title': 'Mycological cure - No', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Mycological cure - Yes', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Proportion with mycological cure', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.4598', 'ciUpperLimit': '0.9384', 'estimateComment': 'The proportion of participants with mycological cure at Day 25 ("Yes") was calculated and presented with a 95% CI. The CI was based on the Wilson score for the proportion of participants recorded as "Yes" with a continuity correction.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 25', 'description': 'Defined as the proportion of patients achieving mycological cure as assessed by vaginal culture at Day 25.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Day 25 Per Protocol Analysis Set - the subset of patients in the Full Analysis Set for whom no protocol deviation judged to impact the Day 25 analyses was reported or identified'}, {'type': 'SECONDARY', 'title': 'Absence of Candida Hyphae in the Wet Smear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gedea Pessary', 'description': 'Gedea pessary administration\n\nGedea pessary: Daily administration of the Gedea pessary for 6 consecutive days'}], 'classes': [{'title': '"Absence of Candida hyphae in the wet smear" - No', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': '"Absence of Candida hyphae in the wet smear" - Yes', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Proportion with absence of Candida', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.3719', 'ciUpperLimit': '0.7603', 'estimateComment': 'The proportion of participants that did not show Candida hyphae in the wet smear (absence of/"Yes") at Day 7-14 was calculated and presented together with a 95% CI based on the Wilson score for the proportion of "Yes" with a continuity correction.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7-14', 'description': 'Proportion of patients having an absence of Candida hyphae in the wet smear at Day 7-14.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change in the Composite Vulvovaginal Signs and Symptoms (CVVS) Score From Screening to Day 7-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gedea Pessary', 'description': 'Gedea pessary administration\n\nGedea pessary: Daily administration of the Gedea pessary for 6 consecutive days'}], 'classes': [{'title': 'CVVS score - Screening', 'categories': [{'measurements': [{'value': '7.46', 'spread': '2.02', 'groupId': 'OG000'}]}]}, {'title': 'CVVS score - Day 7-14', 'categories': [{'measurements': [{'value': '2.96', 'spread': '2.54', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.5', 'ciLowerLimit': '-5.77', 'ciUpperLimit': '-3.23', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.15', 'estimateComment': 'The mean change in the score for composite vulvovaginal signs and symptoms from Screening to Day 7-14 was calculated and presented together with a 95% CI.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From Screening to Day 7-14', 'description': 'Each of the following vulvovaginal signs and symptoms was individually scored using the scoring scale below. The CVVS score is the sum of the 6 individual scores. A lower CVVS score means fewer vulvovaginal signs and symptoms. Change from the score at screening to the score at Day 7-14 is presented.\n\n* Vulvovaginal signs: erythema, edema, or excoriation (Investigator-assessed)\n* Vulvovaginal symptoms: itching, burning, or irritation (Patient-assessed)\n\nScoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense)', 'unitOfMeasure': 'score on a scale (Total range 0-18)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change in the Composite Vulvovaginal Signs and Symptoms (CVVS) Score From Screening to Day 7-14 - Proportions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gedea Pessary', 'description': 'Gedea pessary administration\n\nGedea pessary: Daily administration of the Gedea pessary for 6 consecutive days'}], 'classes': [{'title': 'Reduction in signs/symptoms -No', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Reduction in signs/symptoms -Yes', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Proportion with reduction CVVS score', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.6872', 'ciUpperLimit': '0.9697', 'estimateComment': 'The proportion of participants having a reduction in signs and symptoms (CVVS scores) on Day 7-14 vs. Screening was calculated and presented with a 95% CI based on the Wilson score for the prop. with "Yes" with a continuity correction.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Screening to Day 7-14', 'description': 'Proportion of patients having a reduction in composite vulvovaginal signs and symptoms (CVVS) score on Day 7-14 compared to screening. NB. If the patient used rescue medication between Day 7 and Day 14, Day 7 data was used.\n\nEach of the following vulvovaginal signs and symptoms was individually scored using the scoring scale below. The CVVS score is the sum of the 6 individual scores.\n\n* Vulvovaginal signs: erythema, edema, or excoriation\n* Vulvovaginal symptoms: itching, burning, or irritation\n\nScoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gedea Pessary', 'description': 'Gedea pessary administration\n\nGedea pessary: Daily administration of the Gedea pessary for 6 consecutive days'}], 'classes': [{'title': 'Day 0 (post-treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1-7, Day 11, Day 14, Day 25', 'description': 'The number of participants reported as "Yes" for having a reduction in CVVS score compared to screening is presented.\n\nEach of the following vulvovaginal signs and symptoms was individually scored using the scoring scale below. A lower CVVS score means fewer vulvovaginal symptoms.\n\n• Vulvovaginal symptoms: itching, burning, or irritation\n\nScoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense).\n\nPlease note that assessments at Day 0 refer to the evening assessment post-treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gedea Pessary', 'description': 'Gedea pessary administration\n\nGedea pessary: Daily administration of the Gedea pessary for 6 consecutive days'}], 'classes': [{'title': 'Day 0 (post-treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.200', 'spread': '1.28', 'groupId': 'OG000'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.560', 'spread': '1.92', 'groupId': 'OG000'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.24', 'spread': '1.94', 'groupId': 'OG000'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.40', 'spread': '2.31', 'groupId': 'OG000'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.50', 'spread': '2.45', 'groupId': 'OG000'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.48', 'spread': '1.90', 'groupId': 'OG000'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.75', 'spread': '1.96', 'groupId': 'OG000'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.00', 'spread': '2.19', 'groupId': 'OG000'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.63', 'spread': '2.36', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.70', 'spread': '2.16', 'groupId': 'OG000'}]}]}, {'title': 'Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.77', 'spread': '2.54', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1-7, Day 11, Day 14, Day 25', 'description': 'Change in the sum of the 3 vulvovaginal symptoms scores (itching, burning, and irritation) on Days 1-7, Day 11, Day 14 and Day 25, compared to screening.\n\nVulvovaginal symptoms were individually scored using the scoring scale below.\n\n• Vulvovaginal symptoms: itching, burning, or irritation\n\nScoring scale: each score was objectively defined as 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense).\n\nPlease note that assessments at Day 0 refer to the evening assessment post-treatment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Usability, Measured by Patient Questionnaire on Day 6.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gedea Pessary', 'description': 'Gedea pessary administration\n\nGedea pessary: Daily administration of the Gedea pessary for 6 consecutive days'}], 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 6', 'description': 'Response to the question "is the vaginal pessary easy to use?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (26 patients, 25 patients responded to the question)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gedea Pessary', 'description': 'Gedea pessary administration\n\nGedea pessary: Daily administration of the Gedea pessary for 6 consecutive days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Received study treatment', 'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Gedea Pessary', 'description': 'Gedea pessary administration\n\nGedea pessary: Daily administration of the Gedea pessary for 6 consecutive days'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.1', 'spread': '9.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African descent', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Asian or Pacific Islander', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': 'Mixed/Multi-racial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Other, Central American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Childbearing potential', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Yes', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of vulvovaginal candidiasis infections during the last 12 months', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-04', 'size': 1896235, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-08T09:41', 'hasProtocol': True}, {'date': '2024-03-25', 'size': 1062256, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-08T09:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2022-05-24', 'resultsFirstSubmitDate': '2025-07-08', 'studyFirstSubmitQcDate': '2022-08-17', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-16', 'studyFirstPostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Cure Rate at Day 7-14', 'timeFrame': 'Day 7-14', '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, with no intercurrent events (concomitant anti-fungal therapy or other treatments related to VVC due to lack of clinical performance prior to CVVS evaluation for the primary endpoint definition, treatment discontinuation due to lack of clinical performance, or rescue medication prior to CVVS evaluation for the primary endpoint definition).\n\nEach of the following vulvovaginal signs and symptoms was individually scored using the scoring scale below. The CVVS score is the sum of the 6 individual scores.\n\n* Vulvovaginal signs: erythema, edema, or excoriation\n* Vulvovaginal symptoms: itching, burning, or irritation\n\nScoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense)'}], 'secondaryOutcomes': [{'measure': 'Continued Clinical Response to Treatment at Day 25', 'timeFrame': 'Day 25', 'description': 'Defined as the proportion of patients clinically cured on Day 7-14 and thereafter responding "no" to the yes/no question, "Have the symptoms recurred?" via telephone on Day 25.'}, {'measure': 'Combined Clinical and Mycological Cure at Day 7-14', 'timeFrame': 'Day 7-14', 'description': 'The proportion of patients reporting clinical cure Day 7-14 according to the primary endpoint and mycological cure (culture negative for growth of Candida species).'}, {'measure': 'Mycological Cure at Day 7-14', 'timeFrame': 'Day 7-14', 'description': 'Defined as the proportion of patients having a mycological cure as assessed by vaginal culture at Day 7-14.'}, {'measure': 'Mycological Cure at Day 25', 'timeFrame': 'Day 25', 'description': 'Defined as the proportion of patients achieving mycological cure as assessed by vaginal culture at Day 25.'}, {'measure': 'Absence of Candida Hyphae in the Wet Smear', 'timeFrame': 'Day 7-14', 'description': 'Proportion of patients having an absence of Candida hyphae in the wet smear at Day 7-14.'}, {'measure': 'Change in the Composite Vulvovaginal Signs and Symptoms (CVVS) Score From Screening to Day 7-14', 'timeFrame': 'From Screening to Day 7-14', 'description': 'Each of the following vulvovaginal signs and symptoms was individually scored using the scoring scale below. The CVVS score is the sum of the 6 individual scores. A lower CVVS score means fewer vulvovaginal signs and symptoms. Change from the score at screening to the score at Day 7-14 is presented.\n\n* Vulvovaginal signs: erythema, edema, or excoriation (Investigator-assessed)\n* Vulvovaginal symptoms: itching, burning, or irritation (Patient-assessed)\n\nScoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense)'}, {'measure': 'Change in the Composite Vulvovaginal Signs and Symptoms (CVVS) Score From Screening to Day 7-14 - Proportions', 'timeFrame': 'From Screening to Day 7-14', 'description': 'Proportion of patients having a reduction in composite vulvovaginal signs and symptoms (CVVS) score on Day 7-14 compared to screening. NB. If the patient used rescue medication between Day 7 and Day 14, Day 7 data was used.\n\nEach of the following vulvovaginal signs and symptoms was individually scored using the scoring scale below. The CVVS score is the sum of the 6 individual scores.\n\n* Vulvovaginal signs: erythema, edema, or excoriation\n* Vulvovaginal symptoms: itching, burning, or irritation\n\nScoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense)'}, {'measure': 'Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening', 'timeFrame': 'Day 1-7, Day 11, Day 14, Day 25', 'description': 'The number of participants reported as "Yes" for having a reduction in CVVS score compared to screening is presented.\n\nEach of the following vulvovaginal signs and symptoms was individually scored using the scoring scale below. A lower CVVS score means fewer vulvovaginal symptoms.\n\n• Vulvovaginal symptoms: itching, burning, or irritation\n\nScoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense).\n\nPlease note that assessments at Day 0 refer to the evening assessment post-treatment.'}, {'measure': 'Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening', 'timeFrame': 'Day 1-7, Day 11, Day 14, Day 25', 'description': 'Change in the sum of the 3 vulvovaginal symptoms scores (itching, burning, and irritation) on Days 1-7, Day 11, Day 14 and Day 25, compared to screening.\n\nVulvovaginal symptoms were individually scored using the scoring scale below.\n\n• Vulvovaginal symptoms: itching, burning, or irritation\n\nScoring scale: each score was objectively defined as 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense).\n\nPlease note that assessments at Day 0 refer to the evening assessment post-treatment.'}, {'measure': 'Usability, Measured by Patient Questionnaire on Day 6.', 'timeFrame': 'Day 6', 'description': 'Response to the question "is the vaginal pessary easy to use?"'}]}, '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 a multi-centre, multi-national study to evaluate the clinical performance and safety of treatment with Gedea Pessary in adult women with confirmed vulvovaginal candidiasis (VVC).\n\nThe study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms. A total of 26 patients are planned to be included in the study. On Day 0 (Screening, Visit 1), eligible patients will undergo a gynaecological examination, including collection of composite vulvovaginal signs-and-symptoms (CVVS) score data, and vaginal samples. Patients will be provided with 6 doses of Gedea Pessary that will be self-administered as a daily treatment (Days 0 to 5).\n\nPatients will visit the clinic on Day 7 (+2 days, Visit 2) for gynaecological examinations, including collection of CVVS data for the assessment of clinical cure and reporting of AEs and concomitant medications. On Day 14 (±2 days, Visit 3), patients that did not have a clinical and mycological cure Day 7 will re-visit the clinic for additional gynaecological examinations, including collection of CVVS data for the assessment of clinical cure. Rescue treatment will be offered during visits 2 and 3, if necessary. Patients will have a final telephone follow-up on Day 25 (±3 days, Visit 4), for for reporting of AEs, concomitant medications and potential menstruation onset. Vaginal sampling for culture and sequencing, as well as vaginal pH measurements will be performed at the clinic on Day 0, Day 7, and Day 14. On Day 25, patients will self-perform vaginal swabs at home for sequencing and vaginal culture. Patient questionnaires for assessing VVC symptoms, will be used during the treatment period (Days 0 to 5), 1 day after the treatment (Day 6) and on Days 11 and 25. Usability will be assessed on Day 7, also via the patient questionnaire. The patient questionnaire will be based on an electronic patient reported outcomes (ePRO) system, i.e. a mobile application (ViedocMe™).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Having decisional capacity and providing written informed consent.\n2. Adult, post-menarchal, pre-menopausal women, aged 18 years or older\n3. Diagnosis of VVC, defined as:\n\n * Having a white or creamy vaginal discharge\n * At least 2 of the following signs and symptoms of VVC that are characterised as at least moderate: itching, burning, irritation, oedema, erythema, or excoriation.\n * KOH or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts.\n4. Negative urine pregnancy test at Screening.\n5. Refrain from using any intravaginal products (i.e. contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) until Day 14.\n6. Refrain from sexual intercourse or use a condom until Day 7.\n7. Signed informed consent and willing and able to comply with all study requirements.\n\nExclusion Criteria:\n\n1. Patients with known or apparent signs of other infectious causes of vaginal infection (BV, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at Screening.\n2. Patients who are pregnant or breastfeeding.\n3. Patients who were treated for VVC within 14 days prior to Screening.\n4. Patients who are currently receiving anti-fungal therapy unrelated to VVC or has taken anti-fungal therapy within 14 days prior to Screening.\n5. Patients who have received an investigational drug in a clinical investigation within 30 days prior to Screening.\n6. Known/previous allergy or hypersensitivity to any product constituent or fluconazole.\n7. Any medical condition that in the Investigator's judgements would make the patient unsuitable for inclusion.\n8. More than 3 previous VVC infections during the last 12 months."}, 'identificationModule': {'nctId': 'NCT05507333', 'acronym': 'EpHect', 'briefTitle': 'Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gedea Biotech AB'}, 'officialTitle': 'An Open Labelled Study to Evaluate Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis', 'orgStudyIdInfo': {'id': 'CL4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Gedea pessary', 'description': 'Gedea pessary administration', 'interventionNames': ['Device: pHyph generation II']}], 'interventions': [{'name': 'pHyph generation II', 'type': 'DEVICE', 'otherNames': ['Gedea pessary'], 'description': 'Daily administration of the Gedea pessary during 6 days', 'armGroupLabels': ['Gedea pessary']}]}, 'contactsLocationsModule': {'locations': [{'zip': '405 45', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Carlanderska', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '141 86', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'KS Huddinge', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '182 88', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Danderyds sjukhus', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '75237', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'CTC MTC', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Helena Kopp-Kallner, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Obstetrics & Gynecology, Danderyd Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gedea Biotech AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}