NCT06834594PHASE4Recruiting
Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome
Children's Mercy Hospital Kansas City
Start Date
7/31/2025
Completion Date
7/31/2026
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 Criteria
Age Range: 12 years to 20 years
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.
Interventions
DRUG
Micronized progesterone 200 MG
DRUG
Micronized Progesterone 100 MG
Conditions
Turner SyndromePrimary Ovarian Insufficiency (Poi)
Locations
Children's Mercy Hospital
Kansas City, Missouri 64108
United States