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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06357442
Status
Recruiting
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Conditions

  • Hormone Replacement Therapy
  • Hypogonadotropic Hypogonadism
  • Primary Ovarian Insufficiency

Eligibility Criteria

Sex
FEMALE
Age
12 Years - 25 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jul 1, 2024
Status verified
Dec 2024
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
34 participants (estimated)

Arms

  • Arm: Daily oral micronized progesterone
    On estrogen replacement therapy using 100mg oral daily micronized progesterone
  • Arm: Etonogestrel implant (Nexplanon)
    On estrogen replacement therapy with etonogestrel implant in place

Primary Outcome Measure

Mean change in endometrial thickness after 6 months of progesterone therapy [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Childrens Hospital ColoradoAuroraColorado80045
Julie Friedman, MD
[email protected]
720-777-2667

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By research site
Childrens Hospital Colorado· Aurora, CO

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