Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-14 @ 12:24 PM
Study NCT ID:
NCT01862861
Status:
COMPLETED
Last Update Posted:
2014-07-31
First Post:
2013-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-30', 'studyFirstSubmitDate': '2013-05-22', 'studyFirstSubmitQcDate': '2013-05-22', 'lastUpdatePostDateStruct': {'date': '2014-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy of bioidentical hormone replacement therapy in decreasing the severity of vasomotor symptoms.', 'timeFrame': '12 Week Study', 'description': 'The reduction of severity of vasomotor symptoms will be evaluated by utilizing the Menopause Rating Scale (MRS) from baseline to the end of study at 12 weeks.'}], 'secondaryOutcomes': [{'measure': 'To evaluate health-related quality of life (HrQol)', 'timeFrame': '12 Weeks', 'description': "The quality of life (HrQol) will be evaluated by utilizing the Women's Health Questionnaire (WHQ)at baseline and at end of study at 12 weeks."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bioidentical Hormone Replacement Therapy'], 'conditions': ['Menopause']}, 'referencesModule': {'references': [{'pmid': '23982041', 'type': 'BACKGROUND', 'citation': 'Wepfer ST. The science behind hormone replacement therapy, part ! Int J Pharm Compd. 2001 Nov-Dec;5(6):462-4. No abstract available.'}, {'pmid': '19179815', 'type': 'BACKGROUND', 'citation': 'Holtorf K. The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy? Postgrad Med. 2009 Jan;121(1):73-85. doi: 10.3810/pgm.2009.01.1949.'}, {'pmid': '23981968', 'type': 'BACKGROUND', 'citation': 'Lorentzen J. Hormone replacement therapy: part 1 - the evolution of hormone treatment. Int J Pharm Compd. 2001 Sep-Oct;5(5):336-8. No abstract available.'}, {'pmid': '21651797', 'type': 'BACKGROUND', 'citation': 'Ruiz AD, Daniels KR, Barner JC, Carson JJ, Frei CR. Effectiveness of compounded bioidentical hormone replacement therapy: an observational cohort study. BMC Womens Health. 2011 Jun 8;11:27. doi: 10.1186/1472-6874-11-27.'}, {'pmid': '21961716', 'type': 'BACKGROUND', 'citation': "Thurston RC, Joffe H. Vasomotor symptoms and menopause: findings from the Study of Women's Health across the Nation. Obstet Gynecol Clin North Am. 2011 Sep;38(3):489-501. doi: 10.1016/j.ogc.2011.05.006."}, {'pmid': '16735636', 'type': 'BACKGROUND', 'citation': "Gold EB, Colvin A, Avis N, Bromberger J, Greendale GA, Powell L, Sternfeld B, Matthews K. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. Am J Public Health. 2006 Jul;96(7):1226-35. doi: 10.2105/AJPH.2005.066936. Epub 2006 May 30."}, {'type': 'BACKGROUND', 'citation': "Levin ER, Hammes SR.Chapter 40. Estrogens and Progestins. In: Chabner BA, Bruton LL, Knollman BC, eds. Goodman & Gilman's The Pharmacological Basis of Therapeutics. 12nd ed. New York: McGraw-Hill; 2011. http://www.accesspharmacy.com/content.aspx?aID=16673417. Accessed September 28, 2012"}, {'type': 'BACKGROUND', 'citation': "Snyder PJ. Chapter41. Androgens. In: Chabner BA, Bruton LL, Knollman BC, eds. Goodman & Gillman's The Pharmacological Basis of Therapeutics. 12nd ed. New York: McGraw-Hill; 2011. http;//www.accesspharmacy.com/content.aspx?aID=16673856. Accessed September 28,2012."}, {'pmid': '15495039', 'type': 'BACKGROUND', 'citation': 'Maclennan AH, Broadbent JL, Lester S, Moore V. Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for hot flushes. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD002978. doi: 10.1002/14651858.CD002978.pub2.'}, {'pmid': '15555079', 'type': 'BACKGROUND', 'citation': 'Heinemann LA, DoMinh T, Strelow F, Gerbsch S, Schnitker J, Schneider HP. The Menopause Rating Scale (MRS) as outcome measure for hormone treatment? A validation study. Health Qual Life Outcomes. 2004 Nov 22;2:67. doi: 10.1186/1477-7525-2-67.'}, {'type': 'BACKGROUND', 'citation': "Hunter MS, The Women's Health Questionnaire (WHQ): the development, standardization and application of a measure of mid-aged women's emotional and physical health. Quality of Life Res. 2000;9(1):733-738."}, {'type': 'BACKGROUND', 'citation': 'Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2012.'}, {'pmid': '9699235', 'type': 'BACKGROUND', 'citation': 'Julious SA, Campbell MJ. Sample size calculations for paired or matched ordinal data. Stat Med. 1998 Jul 30;17(14):1635-42. doi: 10.1002/(sici)1097-0258(19980730)17:143.0.co;2-k.'}, {'pmid': '10379691', 'type': 'BACKGROUND', 'citation': 'Julious SA, Campbell MJ, Altman DG. Estimating sample sizes for continuous, binary, and ordinal outcomes in paired comparisons: practical hints. J Biopharm Stat. 1999 May;9(2):241-51. doi: 10.1081/BIP-100101174.'}]}, 'descriptionModule': {'briefSummary': 'Bioidentical Hormone Replacement Therapy (BHRT) to assess a change in the number of various menopausal symptoms such as hot flashes and night sweats in surgically or naturally induced peri or post-menopausal women.', 'detailedDescription': 'Participants will be receiving a customized bioidentical hormone regimen which may include a combination of estrogens, progesterone, and testosterone.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Peri-menopausal or post-menopausal women between the age of 30 and 65 years of age.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must be women who are in surgically or naturally induced menopause or perimenopause, as determined by their physician.\n* Participants must be starting a new regimen of bioidentical hormone replacement therapy.\n* Participants must be expected to receive therapy for at least 12 weeks.\n* Participants must be between 30 and 65 years of age.\n* Participants must be able to provide sound written informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf.\n\nExclusion Criteria:\n\n* Participants must not have prior hypersensitivity or adverse events to any of the components in the customized prescription.\n* Participants must not be pregnant or breastfeeding women.\n* Participants must not be managed outside the Medimix Specialty Pharmacy system with regard to their bioidentical hormone replacement therapy.\n* Participants must not be using another bioidentical hormone at the time of enrollment."}, 'identificationModule': {'nctId': 'NCT01862861', 'acronym': 'REVERT', 'briefTitle': 'Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medimix Specialty Pharmacy, LLC'}, 'officialTitle': 'Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study', 'orgStudyIdInfo': {'id': 'Medimix Pharm-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Peri or post-menopausal women.', 'description': 'Women with peri or post-menopausal vasomotor symptoms between 30 and 60 years of age.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'The Medimix Specialty Pharmacy, LLC', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Benjamin J Epstein, PharmD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Medimix Specialty Pharmacy, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medimix Specialty Pharmacy, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}