Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-01-02 @ 12:29 PM
Study NCT ID:
NCT03185169
Status:
TERMINATED
Last Update Posted:
2018-07-26
First Post:
2017-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GSM (Genitourinary Syndrome Of Menopause) Management In Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D004414', 'term': 'Dyspareunia'}, {'id': 'D053159', 'term': 'Dysuria'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C085472', 'term': 'Replens'}, {'id': 'D000074263', 'term': 'Coconut Oil'}], 'ancestors': [{'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Observational, prospective open label trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'whyStopped': 'Study design change required protocol/ICF changes, deemed more appropriate to terminate study and apply knowledge gained to potential future study design', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-23', 'studyFirstSubmitDate': '2017-05-26', 'studyFirstSubmitQcDate': '2017-06-09', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of GSM signs and/or symptoms', 'timeFrame': '1 month', 'description': 'To show improvement of GSM signs and/or symptoms at month 1 compared to baseline period of administration of the study intervention. This will be measured by administering the Quality of Life DIVA (Day-to-Day Impact of Vaginal Aging) questionnaire.'}, {'measure': 'Improvement of GSM signs and/or symptoms', 'timeFrame': '3 months', 'description': 'To show improvement of GSM signs and/or symptoms at month 3 compared to baseline period of administration of the study intervention. This will be measured by administering the Quality of Life DIVA (Day-to-Day Impact of Vaginal Aging) questionnaire.'}, {'measure': 'Improvement of GSM signs and/or symptoms', 'timeFrame': '6 months', 'description': 'To show improvement of GSM signs and/or symptoms at month 6 compared to baseline period of administration of the study intervention. This will be measured by administering the Quality of Life DIVA (Day-to-Day Impact of Vaginal Aging) questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Sexual health of breast cancer survivors who are sexually active who are enrolled in this study', 'timeFrame': '6 months', 'description': "This study will investigate the sexual health of breast cancer survivors who are sexually active and using Replens™, Preseed™, coconut oil, or the patient's personal lubricant of choice prior to intercourse by the FSFI (Female Sexual Function Index) questionnaire. The percent change, from baseline to 6 months, in painful sexual activity will be explored."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer survivor', 'postmenopausal', 'dysuria', 'dyspareunia', 'vaginal dryness', 'urinary tract infections', 'urinary frequency', 'urinary urgency', 'genital burning', 'genital itching', 'genital dryness'], 'conditions': ['Genitourinary Abnormality', 'Breast Cancer Female', 'Vaginal Abnormality', 'Urinary Tract Infections', 'Dyspareunia', 'Dysuria']}, 'referencesModule': {'references': [{'pmid': '24983271', 'type': 'BACKGROUND', 'citation': 'Huang AJ, Gregorich SE, Kuppermann M, Nakagawa S, Van Den Eeden SK, Brown JS, Richter HE, Walter LC, Thom D, Stewart AL. Day-to-Day Impact of Vaginal Aging questionnaire: a multidimensional measure of the impact of vaginal symptoms on functioning and well-being in postmenopausal women. Menopause. 2015 Feb;22(2):144-54. doi: 10.1097/GME.0000000000000281.'}, {'pmid': '12592244', 'type': 'BACKGROUND', 'citation': 'Davila GW, Singh A, Karapanagiotou I, Woodhouse S, Huber K, Zimberg S, Seiler J, Kopka SL. Are women with urogenital atrophy symptomatic? Am J Obstet Gynecol. 2003 Feb;188(2):382-8. doi: 10.1067/mob.2003.23.'}, {'pmid': '25104582', 'type': 'BACKGROUND', 'citation': 'Larmo PS, Yang B, Hyssala J, Kallio HP, Erkkola R. Effects of sea buckthorn oil intake on vaginal atrophy in postmenopausal women: a randomized, double-blind, placebo-controlled study. Maturitas. 2014 Nov;79(3):316-21. doi: 10.1016/j.maturitas.2014.07.010. Epub 2014 Jul 21.'}, {'pmid': '19436226', 'type': 'BACKGROUND', 'citation': 'Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berube R, Belanger P, Berger L, Gilbert L, Martel C, Balser J. Serum steroid levels during 12-week intravaginal dehydroepiandrosterone administration. Menopause. 2009 Sep-Oct;16(5):897-906. doi: 10.1097/gme.0b013e31819e8930.'}, {'pmid': '8293835', 'type': 'BACKGROUND', 'citation': 'Nachtigall LE. Comparative study: Replens versus local estrogen in menopausal women. Fertil Steril. 1994 Jan;61(1):178-80. doi: 10.1016/s0015-0282(16)56474-7.'}, {'pmid': '10782451', 'type': 'BACKGROUND', 'citation': "Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597."}, {'pmid': '23481118', 'type': 'RESULT', 'citation': 'Erekson EA, Yip SO, Wedderburn TS, Martin DK, Li FY, Choi JN, Kenton KS, Fried TR. The Vulvovaginal Symptoms Questionnaire: a questionnaire for measuring vulvovaginal symptoms in postmenopausal women. Menopause. 2013 Sep;20(9):973-9. doi: 10.1097/GME.0b013e318282600b.'}], 'seeAlsoLinks': [{'url': 'https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071643.pdf', 'label': 'Guidance For Industry: Estrogen And Estrogen/Progestin Drug Products To Treat Vasomotor Symptoms And Vulvar And Vaginal Atrophy Symptoms--Recommendations For Clinical Evaluation'}]}, 'descriptionModule': {'briefSummary': 'The impact of treatment for GSM on the quality of life will be examined for postmenopausal women (defined as last menstrual period \\> 1 year ago or 6 months ago with FSH \\>40) who have been diagnosed with breast cancer.', 'detailedDescription': "Postmenopausal breast cancer survivors who report at least one GSM sign or symptom will be offered participation in an observational, prospective open label trial. Study duration will be 6 months.\n\nEvidence of GSM symptoms will be evaluated by a board certified gynecologist. Upon satisfying the prescreen requirements, the patient's information will be forwarded to the sub-investigator, who will confirm study eligibility and make the final determination verifying the diagnosis of GSM. Participants will be using commercially available Replens applied via prefilled applicator into the vagina and coconut oil applied at the vaginal introitus and vulva. Both are to be administered by the patient 2 times per week, interval between dosing to be approximately 2 days. Patients will be encouraged to apply Preseed, coconut oil, or patient's personal lubricant of choice into the vagina prior to sexual activity. Patients will record dosing on the Intake Diary. Outcome measures will include:\n\nQuality of Life DIVA (Day-to-Day Impact of Vaginal Aging) questionnaire will be administered at Baseline, at month 1, 3 and month 6. The FSFI (Female Sexual Function Index) questionnaire will also be used for sexually active patients at the same time points. This is an exploratory investigation. A planned paired T test will be applied to analyze the outcome and regroup after data has been collected on the first 14 patients."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female\n2. Postmenopausal women (defined as last menstrual period \\> 1 year ago or 6 months ago with FSH \\>40) who have been diagnosed with breast cancer including in situ carcinoma (DCIS, LCIS)\n3. Have self-identified GSM signs and objective symptoms on baseline screening\n4. Patients already using Replens™ or coconut oil will have a two week washout period prior to starting study treatment.\n5. Medical History review and Pelvic Exam by a board certified gynecologist for baseline assessment OR medical records review by a board certified gynecologist or delegated study staff to confirm diagnosis of GSM. If GSM is to be verified by medical record review, the sub-investigator will make the final determination of eligibility.\n\nExclusion Criteria:\n\n1. Use of any estrogen containing product within 4 weeks prior to screening\n2. Endometrial hyperplasia, endometrial cancer, or other gynecologic malignancy\n3. Patients with non GSM related signs and symptoms as verified by a board certified gynecologist will be excluded.\n4. Any concurrent illness or disorder that, per the opinion of the investigator, would preclude the patient from meeting the study requirements.'}, 'identificationModule': {'nctId': 'NCT03185169', 'acronym': 'GSM', 'briefTitle': 'GSM (Genitourinary Syndrome Of Menopause) Management In Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Alta Bates Summit Medical Center'}, 'officialTitle': 'GSM (Genitourinary Syndrome Of Menopause) Management In Breast Cancer Survivors', 'orgStudyIdInfo': {'id': 'GSM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Replens and coconut oil', 'description': "Commercially available Replens applied via prefilled applicator into the vagina and coconut oil applied at the vaginal introitus and vulva. Both are to be administered by the patient 2 times per week, interval between dosing to be approximately 2 days. Patients will be encouraged to apply Preseed, coconut oil, or patient's personal lubricant of choice into the vagina prior to sexual activity.", 'interventionNames': ['Combination Product: Replens and coconut oil']}], 'interventions': [{'name': 'Replens and coconut oil', 'type': 'COMBINATION_PRODUCT', 'armGroupLabels': ['Replens and coconut oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Summit Medical Center', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}], 'overallOfficials': [{'name': 'Uma Suryadevara, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alta Bates Summit Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alta Bates Summit Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Uma Suryadevara', 'investigatorAffiliation': 'Alta Bates Summit Medical Center'}}}}