NCT06357442 Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant.
| NCT ID | NCT06357442 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Primary Ovarian Insufficiency |
| Study Type | OBSERVATIONAL |
| Enrollment | 34 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-07-01 |
Trial Parameters
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Brief 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 Criteria
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