Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome
NCT ID: NCT06834594
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
40 participants
INTERVENTIONAL
2025-07-31
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sequential progesterone supplementation
Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle.
Micronized progesterone 200 MG
Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle
Continuous progesterone supplementation:
Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.
Micronized Progesterone 100 MG
Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.
Interventions
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Micronized progesterone 200 MG
Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle
Micronized Progesterone 100 MG
Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prescribed adult dosing\* of transdermal or oral estradiol for estrogen replacement therapy.
\*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).
* Have achieved menarche.
Exclusion Criteria
* Having a levonorgestrel-releasing intrauterine device or etonogestrel arm implant in place.
* Having received depot medroxyprogesterone within one year prior to study recruitment.
* Non-English or non-Spanish speaking.
12 Years
20 Years
FEMALE
No
Sponsors
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Children's Mercy Hospital Kansas City
OTHER
Responsible Party
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Principal Investigators
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Tazim Dowlut-McElroy, M.D., M.S.
Role: PRINCIPAL_INVESTIGATOR
Children's Mercy Kansas City
Locations
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Children's Mercy Hospital
Kansas City, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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STUDY00003252
Identifier Type: -
Identifier Source: org_study_id
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