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NCT Number: NCT06834594

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

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).

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Key information

Conditions

Turner Syndrome Adnexal Diseases Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Gonadal Disorders Gonadal Dysgenesis Heart Defects, Congenital Heart Diseases Male Urogenital Diseases Ovarian Diseases Primary Ovarian Insufficiency Primary Ovarian Insufficiency (Poi) Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Urogenital Abnormalities Urogenital Diseases

Age range

12 year–20 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location status: Recruiting

Location contact

Allie Ranallo

CONTACT

[email protected]

816-394-2574

Andrea Manlove

CONTACT

[email protected]

+1-816-731-7326

Joseph Cernich, M.D.

SUB_INVESTIGATOR

Madeline Ross, M.D.

SUB_INVESTIGATOR

Tazim Dowlut-McElroy, M.D., M.S.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Micronized progesterone 200 MG

Drug

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

Other names: Sequential

Micronized Progesterone 100 MG

Drug

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

Other names: Continuous

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Endometrial thickness.

    Time frame: On study day 90 +/- 14 days.

    Endometrial thickness measured by transabdominal pelvic ultrasound.

Study contacts

Contact information is provided by the study sponsor or research team.

Allie Ranallo

CONTACT

[email protected]

+1-816-394-7534

Andrea Manlove

CONTACT

[email protected]

+1-816-731-7326

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

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

Acronym: BOOST

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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