NCT06834594 · Children's Mercy Hospital Kansas City
Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome
(BOOST)
What this study is about
This is a single-site open label non-randomly assigned 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).
View original scientific description
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).
Interventions
DRUG
Micronized progesterone 200 MG
Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle
DRUG
Micronized Progesterone 100 MG
Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.
Primary outcome measures
Menstrual bleeding patterns as assessed by the Pictorial Bleeding Assessment Chart (PBAC)
Time frame: From enrollment to end of treatment at day 90.
PBAC is one of the most common scoring systems used in the literature to quantify menstrual blood loss (MBL) using a pictorial scoring system, with a higher score representing a larger MBL and a score \>100 qualifying as heavy menstrual bleeding
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Kansas City, Missouri
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 4, 2025 · Source of record for eligibility and locations