Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Micronized progesterone 200 MG, Micronized Progesterone 100 MG.
- Who it may be relevant to
- Registry conditions: Turner Syndrome, Primary Ovarian Insufficiency (Poi). Basic parameters: 12 years — 20 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome: A Non-randomized Prospective Trial (The BOOST Study)
Overview
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).
Interventions
- Drug Micronized progesterone 200 MG
Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle - Drug Micronized Progesterone 100 MG
Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.
Primary outcome measures
- Menstrual bleeding patterns as assessed by the Pictorial Bleeding Assessment Chart (PBAC) [Time frame: From enrollment to end of treatment at day 90.]
Secondary outcome measures (2)
- Menstrual distress questionnaire (MEDI-Q) [Time frame: From enrollment to end of treatment at day 90.]
- Endometrial thickness. [Time frame: On study day 90 +/- 14 days.]
Eligibility criteria
Inclusion criteria
- Diagnosis of Turner Syndrome and Primary Ovarian Insufficiency.
- 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
- Disclosure of sexual activity and desire for contraception.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Children's Mercy Hospital — Kansas City
Publications
- 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 PMID 38748847
- 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 39660328
- 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 37094554
- 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. PMID 35272055
Identifiers
NCT: NCT06834594 · STUDY00003252