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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.

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

Who can join

Ages 12 to 25 · Women

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

About the study

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.

Sponsor: University of Colorado, Denver · Participants: 34 · Started: Jul 1, 2024

Contact the study team

• Julie C Friedman, MD · Phone: 720-777-2667

Official record on ClinicalTrials.gov — NCT06357442

Locations in the U.S.

Conditions

• Primary Ovarian Insufficiency
• Hypogonadism

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.