Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT05483634
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-09
First Post:
2022-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Compare Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2022-07-31', 'studyFirstSubmitQcDate': '2022-07-31', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale (VAS)', 'timeFrame': '2022/8/10-2024/2/28', 'description': 'Changes in GSM symptoms include vaginal dryness, dyspareunia, itching, burning, dysuria'}, {'measure': 'Vaginal health index score (VHIS)', 'timeFrame': '2022/8/10-2024/2/28', 'description': 'One of the most commonly used scores for the evaluation of vaginal elasticity, secretions, pH, the presence of petechiae on the epithelial mucosa, and hydration'}, {'measure': 'Female Sexual Function Index (FSFI)', 'timeFrame': '2022/8/10-2024/2/28', 'description': 'A brief multidimensional scale for assessing sexual function in women.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Menopause', 'Platelet-rich Plasma', 'Estrogen Replacement Therapy', 'Vaginal Atrophy']}, 'referencesModule': {'references': [{'pmid': '27472999', 'type': 'BACKGROUND', 'citation': 'Gandhi J, Chen A, Dagur G, Suh Y, Smith N, Cali B, Khan SA. Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management. Am J Obstet Gynecol. 2016 Dec;215(6):704-711. doi: 10.1016/j.ajog.2016.07.045. Epub 2016 Jul 26.'}, {'pmid': '28778337', 'type': 'BACKGROUND', 'citation': 'Pitsouni E, Grigoriadis T, Falagas ME, Salvatore S, Athanasiou S. Laser therapy for the genitourinary syndrome of menopause. A systematic review and meta-analysis. Maturitas. 2017 Sep;103:78-88. doi: 10.1016/j.maturitas.2017.06.029. Epub 2017 Jun 27.'}, {'pmid': '30103082', 'type': 'BACKGROUND', 'citation': 'Pitsouni E, Grigoriadis T, Douskos A, Kyriakidou M, Falagas ME, Athanasiou S. Efficacy of vaginal therapies alternative to vaginal estrogens on sexual function and orgasm of menopausal women: A systematic review and meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2018 Oct;229:45-56. doi: 10.1016/j.ejogrb.2018.08.008. Epub 2018 Aug 6.'}, {'pmid': '30798700', 'type': 'BACKGROUND', 'citation': 'Najjarzadeh M, Mohammad Alizadeh Charandabi S, Mohammadi M, Mirghafourvand M. Comparison of the effect of hyaluronic acid and estrogen on atrophic vaginitis in menopausal women: A systematic review. Post Reprod Health. 2019 Jun;25(2):100-108. doi: 10.1177/2053369119830818. Epub 2019 Feb 24. No abstract available.'}, {'pmid': '35194935', 'type': 'BACKGROUND', 'citation': 'Saleh DM, Abdelghani R. Clinical evaluation of autologous platelet rich plasma injection in postmenopausal vulvovaginal atrophy: A pilot study. J Cosmet Dermatol. 2022 Oct;21(10):4269-4275. doi: 10.1111/jocd.14873. Epub 2022 Mar 7.'}]}, 'descriptionModule': {'briefSummary': 'The definition of Genitourinary Syndrome of Menopause (GSM) is the decline of estrogens during menopause results in symptoms and clinical signs from both systems. Estrogen and other hormones production decrease after menopause because the ovaries lose their effectiveness, leading to mucosal atrophy, reduced vaginal moisture, dysuria, urgency, recurrent infection, burning, pruritus and dyspareunia.\n\nThe treatment included vaginal estrogen supplement, vaginal hyaluronic acid supplement, vaginal laser, platelet rich plasma, etc. Observational cohort study will be used for study design, and questionnaire, pelvic examination, vaginal pap smear with maturation index (MI), vaginal pH, and other methods will be used for evaluation of the effectiveness and side effects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Menopause for one year Age above 45 with symptoms of GSM', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with menopause\n* Patients with symptoms of genitourinary syndrome of menopause\n\nExclusion Criteria:\n\n* Genitourinary bleeding or infection without definitive diagnosis\n* Coagulopathy\n* Allergy to medication or therapy related with the treatment\n* Chronic disease that might influence outcome\n* Using medication that might influence outcome in 30 days\n* Using hormone or steroid within 8 weeks'}, 'identificationModule': {'nctId': 'NCT05483634', 'briefTitle': 'Compare Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause', 'organization': {'class': 'OTHER', 'fullName': 'Mackay Memorial Hospital'}, 'officialTitle': 'Compare the Effectiveness and Side Effects of Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause', 'orgStudyIdInfo': {'id': '19MMHIS340e'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Genital urinary symptoms of menopause', 'description': 'Menopause for one year, or age above 45 with symptoms of GSM', 'interventionNames': ['Drug: Vaginal estrogen supplement', 'Procedure: Platelet-rich plasma injection']}], 'interventions': [{'name': 'Vaginal estrogen supplement', 'type': 'DRUG', 'description': 'Daily vaginal estrogen supplement, then twice per week. Continue for three months.', 'armGroupLabels': ['Genital urinary symptoms of menopause']}, {'name': 'Platelet-rich plasma injection', 'type': 'PROCEDURE', 'description': 'Monthly platelet-rich plasma injection for three months', 'armGroupLabels': ['Genital urinary symptoms of menopause']}]}, 'contactsLocationsModule': {'locations': [{'zip': '104', 'city': 'Taipei', 'country': 'Taiwan', 'contacts': [{'name': 'Hui-Hsuan Lau, MD', 'role': 'CONTACT', 'email': 'huihsuan1220@gmail.com', 'phone': '+88625433535'}], 'facility': 'MacKay Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Hui-Hsuan Lau', 'role': 'CONTACT', 'email': 'huihsuan1220@gmail.com', 'phone': '+886-25433535'}], 'overallOfficials': [{'name': 'Hui-Hsuan Lau', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mackay Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mackay Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Hui-Hsuan Lau, MD', 'investigatorAffiliation': 'Mackay Memorial Hospital'}}}}