Bleeding patterns with sequential versus continuous progesterone in adolescents with Turner syndrome
Official title: Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome: A Non-randomized Prospective Trial (The BOOST Study)
Run by Children's Mercy Hospital Kansas City · NCT06834594 · Data updated 2026-11-12
This study will test whether taking progesterone continuously or in a sequential (monthly) schedule changes bleeding patterns in adolescents with Turner syndrome who are on estrogen replacement therapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years to 20 Years |
| Sex | Women only |
| Enrollment | 40 (estimated) |
| Sponsor | Children's Mercy Hospital Kansas City Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Status | Recruiting |
| Started | July 31, 2025 |
| Main results expected | July 30, 2028 |
| Study ends | July 31, 2028 |
| Registry record updated | August 25, 2026 |
| Trial ID | NCT06834594 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adolescents with Turner syndrome and primary ovarian insufficiency who have achieved menarche and are prescribed adult-dose transdermal or oral estradiol are the intended participants.
✕Probably not a fit
Patients who desire contraception, who have levonorgestrel IUDs or etonogestrel implants, who received depot medroxyprogesterone in the past year, or who are not English- or Spanish-speaking would not be eligible and would not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-site, open-label, non-randomized study at a pediatric center compares bleeding outcomes when adolescents with Turner syndrome and primary ovarian insufficiency use either continuous or sequential micronized progesterone alongside prescribed adult-dose estradiol. Participants who have achieved menarche and meet estradiol dosing per guidelines will be assigned to one of two progesterone regimens (micronized progesterone 100 mg or 200 mg formulations and dosing schedules). Study staff will track bleeding patterns and related symptoms over the treatment periods and record safety and tolerability. The design excludes patients using certain contraceptives or recent depot progestins and requires English or Spanish language fluency.
Why it matters
Potential benefit: If successful, the results could help clinicians choose a progesterone schedule that produces more predictable or better-tolerated bleeding for adolescents with Turner syndrome on HRT.
How similar studies have gone: Progesterone scheduling has been explored in other hypogonadal or HRT populations, but direct data in adolescents with Turner syndrome are limited, so this is a relatively understudied application.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Children's Mercy Hospital
Kansas City, Missouri, United States Recruiting
Study contacts
- Principal investigator: Tazim Dowlut-McElroy, M.D., M.S. — Children's Mercy Kansas City
- Study coordinator: Allie Ranallo
- Email: alranallo@cmh.edu
- Phone: +1-816-394-7534
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.