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Search / Trial NCT06834594

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

Launched by CHILDREN'S MERCY HOSPITAL KANSAS CITY · Feb 14, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Turner Syndrome Primary Ovarian Insufficiency Hormone Replacement Therapy

ClinConnect Summary

This clinical trial is studying how different ways of using progesterone supplements affect bleeding patterns in girls and young women with Turner Syndrome and primary ovarian insufficiency, which means their ovaries don't produce enough hormones. The trial compares two methods: one where progesterone is taken in a sequence with estrogen, and another where it is taken continuously. The goal is to see which method is better for managing bleeding.

To be eligible for this study, participants must be female, diagnosed with Turner Syndrome and primary ovarian insufficiency, and already receiving hormone replacement therapy with estrogen. They should have started their periods (menarche) as well. Participants can expect to take progesterone as part of their treatment plan and will be monitored for how it affects their bleeding patterns. It's important to note that this trial is not yet recruiting participants, and those who are currently using certain types of birth control or have recently received specific hormone treatments may not be eligible to join.

Gender

FEMALE

Eligibility 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.

About Children's Mercy Hospital Kansas City

Children's Mercy Hospital Kansas City is a renowned pediatric healthcare institution dedicated to advancing the health and well-being of children through innovative research and clinical trials. As a leading sponsor of clinical trials, the hospital focuses on developing and testing new treatments and therapies that address a wide range of pediatric conditions. With a commitment to excellence in patient care and a collaborative approach to research, Children's Mercy is at the forefront of pediatric medicine, striving to improve outcomes and enhance the quality of life for children and their families.

Locations

Kansas City, Missouri, United States

Patients applied

0 patients applied

Trial Officials

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

Principal Investigator

Children's Mercy Kansas City

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported