Clinical practice guidelines for the care of girls and women with Turner syndrome.
Claus H Gravholt, Niels H Andersen, Sophie Christin-Maitre...
https://pubmed.ncbi.nlm.nih.gov/38748847Actively Recruiting
Phase 4
Age: 12Years - 20Years
FEMALE
ID06834594
Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome: A Non-randomized Prospective Trial (The BOOST Study)
Led by Children's Mercy Hospital Kansas City · Updated on 2025-09-04
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two different progesterone supplementation methods in adolescents and young women with Turner Syndrome who also have primary ovarian insufficiency and are prescribed hormone replacement therapy. This Phase 4, single-site, open-label, non-randomized study compares sequential versus continuous use of progesterone to understand differences in menstrual bleeding patterns. Participants receive either oral micronized progesterone 200 mg for the first 12 days of a 30 to 31-day cycle (sequential supplementation) or oral micronized progesterone 100 mg daily throughout the entire 30 to 31-day cycle (continuous supplementation). Both regimens are studied over a 90-day treatment period. During the study, participants will track menstrual bleeding using the Pictorial Bleeding Assessment Chart, complete a menstrual distress questionnaire, and have endometrial thickness measured near the end of treatment. Researchers will assess these outcomes from enrollment through the 90-day treatment to understand how each progesterone regimen affects menstrual patterns and related symptoms.
CONDITIONS
Brief Title
Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome
Who Can Participate
Age: 12Years - 20Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Diagnosis of Turner Syndrome and Primary Ovarian Insufficiency.
- Prescribed adult dosing of transdermal or oral estradiol for estrogen replacement therapy (50-200 µg/day transdermal estradiol or 2-4 mg/day oral estradiol).
- Have achieved menarche.
- Female participants aged 12 to 20 years.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 90 days
Participants receive oral micronized progesterone either sequentially for the first 12 days of a 30 to 31-day cycle or continuously at a lower daily dose throughout the 30 to 31-day cycle.
Visits at enrollment and periodic assessments during treatment
Trial Site Locations
Total: 1 location
1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
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Research Team
A
Allie Ranallo
A
Andrea Manlove
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Evidence-based guideline: premature ovarian insufficiency.
Nick Panay, Richard A Anderson, Amy Bennie...
https://pubmed.ncbi.nlm.nih.gov/39660328Hormone Replacement Therapy after Pubertal Induction in Adolescents and Young Adults with Turner Syndrome: A Survey Study.
Tazim Dowlut-McElroy, Roopa Kanakatti Shankar
https://pubmed.ncbi.nlm.nih.gov/37094554The Care of Adolescents and Young Adults with Turner Syndrome: A Pediatric and Adolescent Gynecology Perspective.
Tazim Dowlut-McElroy, Roopa Kanakatti Shankar
https://pubmed.ncbi.nlm.nih.gov/35272055