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Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant.

NCT06357442 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 34

Last updated 2024-12-06

No results posted yet for this study

Summary

The goal of this observational study is to compare endometrial stripe thickness in adolescent and young adult (AYA) patients with a uterus on estrogen replacement therapy using oral progesterone versus the etonogstrel implant for endometrial protection.

The main questions it aims to answer are:

Aim 1: Characterize the mean endometrial thickness in AYA on estrogen hormone replacement therapy before initiation of progesterone therapy

Aim 2: Characterize the mean changes and variability in endometrial thickness in AYA treated for 6 months with either the etonogestrel implant or continuous oral progesterone

Aim 3: Assess satisfaction, side effects, bleeding patterns, any progesterone modifications, and adherence in AYA treated for 6 months with either etonogestrel implant or continuous progesterone

Participants will be asked to:

* Get two pelvic ultrasounds
* Fill out two surveys
* Continue their current hormone replacement therapy
* Initiate one of two progesterone therapies (prometrium 100mg daily or Nexplanon)

Researchers will compare the change in endometrial thickness after 6 months of progesterone use to see if there is a significant difference in the mean change between the prometrium and Nexplanon groups.

Conditions

  • Primary Ovarian Insufficiency
  • Hypogonadotropic Hypogonadism
  • Hormone Replacement Therapy

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Eligibility

Min Age
12 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2026-07-01
Completion
2026-07-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06357442 on ClinicalTrials.gov