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
University of Colorado, Denver
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.
Description
Study Design and Research Methods This study is a prospective, observational pilot study to assess the acceptability of study procedures and describe initial trends in our outcomes of interest, including endometrial stripe thickness among patients on estrogen replacement therapy after six months of either continuous oral micronized progesterone or etonogestrel implant. Participants will self-select into one of two study arms: (1) oral micronized progesterone (Prometrium), 100mg daily; or (2) etonogestrel implant (Nexplanon). Recruitment and Enrollment Providers will identify eligible patients…
Eligibility
- Age range
- 12–25 years
- Sex
- Female
- Healthy volunteers
- No
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 ul…
Location
- Childrens Hospital ColoradoAurora, Colorado