RecruitingPhase 4NCT06834594

Bleeding Patterns in Sequential and Continuous Progesterone Supplementation 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)


Sponsor

Children's Mercy Hospital Kansas City

Enrollment

40 participants

Start Date

Jul 31, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 12 YearsMax Age: 20 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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.

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Interventions

DRUGMicronized progesterone 200 MG

Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle

DRUGMicronized Progesterone 100 MG

Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.


Locations(1)

Children's Mercy Hospital

Kansas City, Missouri, United States

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NCT06834594


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