Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome (BOOST)

August 27, 2025 updated by: Children's Mercy Hospital Kansas City

Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome: A Non-randomized Prospective Trial (The BOOST Study)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tazim Dowlut-McElroy, M.D., M.S.
        • Sub-Investigator:
          • Madeline Ross, M.D.
        • Sub-Investigator:
          • Joseph Cernich, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sequential progesterone supplementation
Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle.
Drug: Micronized progesterone 200 MG
Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle
Other Names:
  • Sequential
Active Comparator: Continuous progesterone supplementation:
Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.
Drug: Micronized Progesterone 100 MG
Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.
Other Names:
  • Continuous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to end of treatment at day 90.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menstrual distress questionnaire (MEDI-Q)
Time Frame: From enrollment to end of treatment at day 90.
The Menstrual distress questionnaire (MEDI-Q) is a valid and reliable instrument for the assessment of menstrual distress and its impact on psychological well-being. This tool can be utilized in research and clinical settings to comprehensively investigate the impact of menstruation on various populations
From enrollment to end of treatment at day 90.
Endometrial thickness.
Time Frame: On study day 90 +/- 14 days.
Endometrial thickness measured by transabdominal pelvic ultrasound.
On study day 90 +/- 14 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Investigators

  • Principal Investigator: Tazim Dowlut-McElroy, M.D., M.S., Children's Mercy Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2025

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

February 19, 2025

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003252

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Protect confidentiality of individuals with this rare disease (Turner syndrome).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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