Bleeding patterns with sequential versus continuous progesterone in adolescents with Turner syndrome
Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome: A Non-randomized Prospective Trial (The BOOST Study)
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 |
| Enrollment | 40 (estimated) |
| Ages | 12 Years to 20 Years |
| Sex | Female |
| Sponsor | Children's Mercy Hospital Kansas City Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Trial ID | NCT06834594 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Kansas City, Missouri
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.