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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.

Recruitingn/aAges 12 Years - 25 YearsFemaleUniversity of Colorado, Denver
NCT06357442 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 * Con

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
Childrens Hospital Colorado
Aurora, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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