Actively Recruiting
Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant.
Led by University of Colorado, Denver · Updated on 2024-12-06
34
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 to 25 years at baseline
- Female assigned at birth with a uterus
- Diagnosis of primary ovarian insufficiency or hypogonadotropic hypogonadism requiring estrogen replacement therapy
- Receiving oral estradiol (1-2 mg) or transdermal estradiol (0.05-0.1 mg) for at least 3 months
- Never used progesterone therapy or stopped it at least 90 days before enrollment
- Willing to start progesterone therapy
You will not qualify if you...
- Uterine abnormalities such as M�fcllerian anomaly or uterine fibroids
- Unable to clearly see the endometrial lining on ultrasound
- History of chemotherapy or radiation therapy
- Unable to complete study questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Childrens Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
J
Julie C Friedman, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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