What this study is
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.
Study details
- Official title
- 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
- Sponsor
- University of Colorado, Denver
- Conditions
- Primary Ovarian Insufficiency · Hypogonadotropic Hypogonadism · Hormone Replacement Therapy
- Enrolling
- 34 people
- Starts
- 2024-07-01
- Est. completion
- 2026-07-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 12 Years – 25 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Uterine abnormality (e.g., Müllerian Anomaly, uterine fibroids)
- Inability to characterize the endometrial lining on ultrasound
- History of chemotherapy or radiation therapy
- Inability to complete study questionnaire
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openChildrens Hospital Colorado
Aurora, Colorado, United States
- Julie Friedman, MD · Contact720-777-2667julie.friedman@cuanschutz.edu
Recruiting
Study team
Sponsor
University of Colorado, Denver
Study ID 23-2305
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.