Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome: A Non-randomized Prospective Trial (The BOOST Study)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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).
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 12
Maximum Age: 20
Healthy Volunteers: f
View:
• 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.
Locations
United States
Missouri
Children's Mercy Hospital
RECRUITING
Kansas City
Contact Information
Primary
Allie Ranallo
alranallo@cmh.edu
+1-816-394-7534
Backup
Andrea Manlove
almanlove@cmh.edu
+1-816-731-7326
Time Frame
Start Date: 2025-07-31
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 40
Treatments
Active_comparator: Sequential progesterone supplementation
Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle.
Active_comparator: Continuous progesterone supplementation:
Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.
Related Therapeutic Areas
Sponsors
Leads: Children's Mercy Hospital Kansas City