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NCT06834594 | NOT YET RECRUITING | Turner Syndrome

Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome
Sponsor:

Children's Mercy Hospital Kansas City

Information provided by (Responsible Party):

Tazim Dowlut-Melroy

Brief 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).

Condition or disease

Turner Syndrome

Primary ovarian insufficiency (then)

Intervention/treatment

Micronized progesterone 200 MG

Micronized Progesterone 100 MG

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome: A Non-randomized Prospective Trial (The BOOST Study)
Actual Study Start Date : 2025-05-13
Estimated Primary Completion Date : 2026-04-30
Estimated Study Completion Date : 2026-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 12 Years to 20 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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.
Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome

Location Details

NCT06834594

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How to Participate

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Locations

Not yet recruiting

United States, Missouri

Children's Mercy Hospital

Kansas City, Missouri, United States, 64108