Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Continuous Oral Micronized Progesterone Versus the Etonogestrel Implant: a Prospective Pilot Study

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 12
Maximum Age: 25
Healthy Volunteers: f
View:

• Age 12-25 years at baseline

• Female assigned at birth, with uterus

• Diagnosis of primary ovarian insufficiency or hypogonadotropic hypogonadism, requiring estrogen replacement therapy

• Receiving estradiol therapy-oral (1-2mg) or transdermal (0.05-0.1mg)-for at least 3 months

• Never used progesterone therapy or discontinued progesterone therapy at least 90-days prior to enrollment

• Consents to initiating progesterone therapy

Locations
United States
Colorado
Childrens Hospital Colorado
RECRUITING
Aurora
Contact Information
Primary
Julie C Friedman, MD
julie.friedman@cuanschutz.edu
720-777-2667
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 34
Treatments
Daily oral micronized progesterone
On estrogen replacement therapy using 100mg oral daily micronized progesterone
Etonogestrel implant (Nexplanon)
On estrogen replacement therapy with etonogestrel implant in place
Sponsors
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov

Similar Clinical Trials