Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-02-24 @ 11:01 AM
Study NCT ID:
NCT06834594
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014424', 'term': 'Turner Syndrome'}, {'id': 'D016649', 'term': 'Primary Ovarian Insufficiency'}], 'ancestors': [{'id': 'D006059', 'term': 'Gonadal Dysgenesis'}, {'id': 'D012734', 'term': 'Disorders of Sex Development'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D058533', 'term': 'Sex Chromosome Disorders of Sex Development'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025064', 'term': 'Sex Chromosome Disorders'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011374', 'term': 'Progesterone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-02-14', 'studyFirstSubmitQcDate': '2025-02-14', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Menstrual bleeding patterns as assessed by the Pictorial Bleeding Assessment Chart (PBAC)', 'timeFrame': 'From enrollment to end of treatment at day 90.', 'description': 'PBAC is one of the most common scoring systems used in the literature to quantify menstrual blood loss (MBL) using a pictorial scoring system, with a higher score representing a larger MBL and a score \\>100 qualifying as heavy menstrual bleeding'}], 'secondaryOutcomes': [{'measure': 'Menstrual distress questionnaire (MEDI-Q)', 'timeFrame': 'From enrollment to end of treatment at day 90.', 'description': 'The Menstrual distress questionnaire (MEDI-Q) is a valid and reliable instrument for the assessment of menstrual distress and its impact on psychological well-being. This tool can be utilized in research and clinical settings to comprehensively investigate the impact of menstruation on various populations'}, {'measure': 'Endometrial thickness.', 'timeFrame': 'On study day 90 +/- 14 days.', 'description': 'Endometrial thickness measured by transabdominal pelvic ultrasound.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Turner syndrome', 'Primary ovarian insufficiency', 'Hormone replacement therapy'], 'conditions': ['Turner Syndrome', 'Primary Ovarian Insufficiency (Poi)']}, 'referencesModule': {'references': [{'pmid': '38748847', 'type': 'BACKGROUND', 'citation': 'Gravholt CH, Andersen NH, Christin-Maitre S, Davis SM, Duijnhouwer A, Gawlik A, Maciel-Guerra AT, Gutmark-Little I, Fleischer K, Hong D, Klein KO, Prakash SK, Shankar RK, Sandberg DE, Sas TCJ, Skakkebaek A, Stochholm K, van der Velden JA; International Turner Syndrome Consensus Group; Backeljauw PF. Clinical practice guidelines for the care of girls and women with Turner syndrome. Eur J Endocrinol. 2024 Jun 5;190(6):G53-G151. doi: 10.1093/ejendo/lvae050.'}, {'pmid': '39660328', 'type': 'BACKGROUND', 'citation': 'Panay N, Anderson RA, Bennie A, Cedars M, Davies M, Ee C, Gravholt CH, Kalantaridou S, Kallen A, Kim KQ, Misrahi M, Mousa A, Nappi RE, Rocca WA, Ruan X, Teede H, Vermeulen N, Vogt E, Vincent AJ; ESHRE, ASRM, CREWHIRL, and IMS Guideline Group on POI. Evidence-based guideline: premature ovarian insufficiency. Hum Reprod Open. 2024 Dec 9;2024(4):hoae065. doi: 10.1093/hropen/hoae065. eCollection 2024.'}, {'pmid': '37094554', 'type': 'BACKGROUND', 'citation': 'Dowlut-McElroy T, Kanakatti Shankar R. Hormone Replacement Therapy after Pubertal Induction in Adolescents and Young Adults with Turner Syndrome: A Survey Study. Horm Res Paediatr. 2024;97(1):62-69. doi: 10.1159/000530724. Epub 2023 Apr 24.'}, {'pmid': '35272055', 'type': 'BACKGROUND', 'citation': 'Dowlut-McElroy T, Shankar RK. The Care of Adolescents and Young Adults with Turner Syndrome: A Pediatric and Adolescent Gynecology Perspective. J Pediatr Adolesc Gynecol. 2022 Aug;35(4):429-434. doi: 10.1016/j.jpag.2022.02.002. Epub 2022 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'This is a single-site open label non-randomized study comparing effects of sequential versus continuous use of progesterone supplementation amongst Turner Syndrome (TS) patients with primary ovarian insufficiency (POI) prescribed hormone replacement therapy (HRT).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Turner Syndrome and Primary Ovarian Insufficiency.\n* Prescribed adult dosing\\* of transdermal or oral estradiol for estrogen replacement therapy.\n\n \\*Adult dosing of will be defined per published clinical practice guidelines from the 2023 International Turner Syndrome Meeting (i.e. 50-200μg/day of transdermal estradiol, or (i.e. 50-200μg/day of transdermal estradiol or 2-4mg/day oral estradiol).\n* Have achieved menarche.\n\nExclusion Criteria:\n\n* Disclosure of sexual activity and desire for contraception.\n* Having a levonorgestrel-releasing intrauterine device or etonogestrel arm implant in place.\n* Having received depot medroxyprogesterone within one year prior to study recruitment.\n* Non-English or non-Spanish speaking.'}, 'identificationModule': {'nctId': 'NCT06834594', 'acronym': 'BOOST', 'briefTitle': 'Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome: A Non-randomized Prospective Trial (The BOOST Study)', 'orgStudyIdInfo': {'id': 'STUDY00003252'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sequential progesterone supplementation', 'description': 'Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle.', 'interventionNames': ['Drug: Micronized progesterone 200 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous progesterone supplementation:', 'description': 'Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.', 'interventionNames': ['Drug: Micronized Progesterone 100 MG']}], 'interventions': [{'name': 'Micronized progesterone 200 MG', 'type': 'DRUG', 'otherNames': ['Sequential'], 'description': 'Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle', 'armGroupLabels': ['Sequential progesterone supplementation']}, {'name': 'Micronized Progesterone 100 MG', 'type': 'DRUG', 'otherNames': ['Continuous'], 'description': 'Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.', 'armGroupLabels': ['Continuous progesterone supplementation:']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Allie Ranallo', 'role': 'CONTACT', 'email': 'alranallo@cmh.edu', 'phone': '816-394-2574'}, {'name': 'Andrea Manlove', 'role': 'CONTACT', 'email': 'almanlove@cmh.edu', 'phone': '+1-816-731-7326'}, {'name': 'Tazim Dowlut-McElroy, M.D., M.S.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Madeline Ross, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Joseph Cernich, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'centralContacts': [{'name': 'Allie Ranallo', 'role': 'CONTACT', 'email': 'alranallo@cmh.edu', 'phone': '+1-816-394-7534'}, {'name': 'Andrea Manlove', 'role': 'CONTACT', 'email': 'almanlove@cmh.edu', 'phone': '+1-816-731-7326'}], 'overallOfficials': [{'name': 'Tazim Dowlut-McElroy, M.D., M.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Kansas City"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Protect confidentiality of individuals with this rare disease (Turner syndrome).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}