Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT02162160
Status:
COMPLETED
Last Update Posted:
2015-11-26
First Post:
2013-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbiological Impact of an Intimate Cream and Its Suitability to Contribute to the Feeling of Softness and Freshness in the Intimate Area of Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059268', 'term': 'Atrophic Vaginitis'}], 'ancestors': [{'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-25', 'studyFirstSubmitDate': '2013-11-21', 'studyFirstSubmitQcDate': '2014-06-10', 'lastUpdatePostDateStruct': {'date': '2015-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of at least one LN bacteria strain in the intimate area of women in the intervention group', 'timeFrame': 'the end of a 10 days crème-usage', 'description': 'Bacterial Culture of LN bacterial strains'}], 'secondaryOutcomes': [{'measure': 'Obtain information about the coliform bacteria flora in respect to E. coli flora in the external intimate area', 'timeFrame': 'at the end of creme usage and 10 days after finished crème-usage (9-11 days after).', 'description': 'Measured by bacterial Culture and subtyping by PCR'}, {'measure': 'subjective feeling of dryness and freshness in the intimate of women', 'timeFrame': 'the end of the 10 days crème-usage (Day 8-10) and 10 days after finished crème-usage (9-11 days after)', 'description': 'Assessed through self adminstered questionnair with grading of feeling of dryness and freshness on a scale from 0 (no dryness and feeling fresh) to 5 (max dryness and absolutely not feeling fresh)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['probiotic', 'post-menopausal', 'atrophic vaginitis'], 'conditions': ['Post Menopausal Dryness in the Intimate Area of Women']}, 'descriptionModule': {'briefSummary': 'Generate more information on the use of the Probiotic Intimate Crème regarding feeling of dryness and freshness in the intimate area, as well as to evaluate the Lactobacillus flora and presence of coliform bacteria in respect to E. coli in the intimate area of women before use of the crème and at the end of a 10 days crème-usage (day 8-10), as well as 10 days after (9-11 days) finished crème-usage.\n\nThe hypothesis is that lactobacilli can survive in the intimate area of postmenopausal women with use of a probiotic creme.', 'detailedDescription': "The rational for using probiotics is that the humans are colonized by a numbers of microorganisms from birth. These microorganisms are the natural flora of the human body. This bacterial ecology may be imbalanced due different circumstances: excessive hygiene, use of antibiotics or other drugs, use of alcohol, smoking, stress, diabetes and many other factors. The natural bacterial flora in the external part of the genital tract might be promoted by help of intimate products containing probiotics.\n\nThe study objectives Generate more information on the use of the Probiotic Intimate Crème regarding feeling of dryness and freshness in the intimate area, as well as to evaluate the Lactobacillus flora and presence of coliform bacteria in respect to E. coli in the intimate area of women before and at the end of a 10 days crème-usage (day 8-10), as well as 10 (9-11) days after finished crème-usage.\n\nThe primary endpoint of the study Presence of at least one LN bacteria strain in the intimate area of women in the intervention group compared to the intimate area of women in the control group at the end of a 10 days crème-usage (Day 8-10), as well as 10 (9-11) days after finished crème-usage. The primary endpint will be measured by bacterial Culture.\n\nNone-parametric statistical analyses.\n\nSecondary endpoints Obtain information about the coliform bacteria flora in respect to E. coli flora in the external intimate area before and at the end of the 10 days crème-usage (Day 8-10), as well as 10 days after finished crème-usage (9-11 days after).\n\nObtain information about the subjective feeling of dryness and freshness in the intimate of women before and at the end of the 10 days crème-usage (Day 8-10), as well as 10 days after finished crème-usage (9-11 days after).\n\nOnly descriptive statistics.\n\nBlinding The active and comparative test product will be filled into white tubes with identical appearance.\n\nThe study will be conducted with double-blind design when neither the personnel at the clinic and the participants knows which product they are submitted/received. The study will also be blinded for the laboratory personnel analyzing the samples.\n\nRandomization procedure The women will be randomly assigned to active or comparative test products. Based on a computer-generated list, before start of the study, nine tubes containing Probiotic Intimate Crème (the active product) and 9 tubes containing Soothing crème (the control product) will be randomly assigned to a number between 1 to 18, and the tubes labeled with the numbers. The numbered but otherwise visually identical tubes will delivered to the clinic before start of the study.\n\nDuring the first visit, the participants will receive a tube consecutively in numerical order, as they are included in the study, i.e. according to their participant number.\n\nThe computer-generated randomization list and the product labeling will be carried out by people who don't have direct contact with the study participants.\n\nSample collection\n\nVaginal samples:\n\nThe samples will be taken by rolling sterile swabs over the upper third part of the lateral vaginal wall.\n\nLabial samples:\n\nFor labial sampling, on the left side of the vulva near the vaginal orifice, the labia minor and major will be held apart and a sterile swab will be gently rubbed back and forth five times during rotation. The labial examination area will be approximately 2 cm2.\n\nThe swabs will then be placed in a prepared transport medium and sent to laboratory for analyses.\n\n6.12. Study outline\n\nVisit 1:\n\n1. Women visiting the clinic will be recruited to the study. After obtained information (Appendix 1) and signed informed consent the women will be clinically examined for any clinical symptoms of Candida vaginitis (ocular examination) and bacterial vaginosis (Amsel's criteria). The dryness of the mucus membranes will be also examined and the vaginal pH measured using a pH-stick.\n2. Women fulfilling the inclusion criteria will be randomized to 10 days use of test product (Probiotic Intimate Crème) or control product (Soothing Cream, ACO); 2 times daily, every morning and evening at bed time.\n3. The women will receive detailed instructions about how to use the study products.\n4. They will also asked to return the empty tube or remaining product at the end of study (Visit 3)\n5. The women will answer a questioner regarding their subjective feeling of dryness and freshness in their intimate are and rate their feeling on a ten-point scale.\n6. Samples with sterile swabs will be collected from vagina, labia and perineum (Sample 1-L, Sample 1-V) and sent to an independent laboratory for analyses.\n\nVisit 2:\n\n1. The 8th-10th day of the intimate crème-usage period, the women will return to the clinic. The dryness of their mucus membranes will be clinically examined and the vaginal pH.\n2. They will answer a questioner regarding their subjective feeling of dryness and freshness in their intimate are and rate their feeling on a on a ten-point scale. They will also answer questions regarding their purchase intentions and intentions to recommend the product to other women.\n3. Vaginal and labial swabs will be collected (Sample 2-L, Sample 2-V) and send to an independent laboratory for analyses.\n\nVisit 3:\n\n1. 9-11 days after the 10 days crème-usage period, the women will return to the clinic. The dryness of their mucus membranes will be clinically examined and the vaginal pH measured.\n2. They will answer a questioner regarding their subjective feeling of dryness and freshness in their intimate are and rate their feeling on a ten-point scale. They will also answer questions regarding their purchase intentions and intentions to recommend the product to other women.\n3. Vaginal and labial swabs will be collected. (Sample 3-L, Sample 3-V) and sent to an independent laboratory for analyses.\n\nDuring each visit, data will be recorded in the CRF."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy women 45-65 years old\n* with subjective dryness in the intimate area\n* postmenopausal with last menstruation more than or equal to 3 years prior to entering the study\n* being willing to abstain sexual intercourse during the study period\n\nExclusion Criteria:\n\n* yeast infection or bacterial vaginosis\n* use of antibiotics or antifungals\n* use of estrogen\n* participation in Another study'}, 'identificationModule': {'nctId': 'NCT02162160', 'briefTitle': 'Microbiological Impact of an Intimate Cream and Its Suitability to Contribute to the Feeling of Softness and Freshness in the Intimate Area of Women', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Microbiological Impact of a Cream and the Feeling of Softness and Freshness in the Intimate Area of Women', 'orgStudyIdInfo': {'id': 'KI DS 2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic creme', 'description': 'Women receing probiotic creme', 'interventionNames': ['Device: probiotic creme']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Women receiving a moisturizer', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'probiotic creme', 'type': 'DEVICE', 'otherNames': ['Ellen AB'], 'description': 'Probiotic creme applied', 'armGroupLabels': ['Probiotic creme']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Creme without probiotics applied in same manner', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18288', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Dept of Obstetrics and Gynecology, Dnderyds Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Helena Kopp Kallner, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant, MD, PhD', 'investigatorFullName': 'Helena Kopp Kallner', 'investigatorAffiliation': 'Karolinska Institutet'}}}}