Status:
RECRUITING
Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant.
Lead Sponsor:
University of Colorado, Denver
Conditions:
Primary Ovarian Insufficiency
Hypogonadotropic Hypogonadism
Eligibility:
FEMALE
12-25 years
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 versu...
Detailed 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, includ...
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
Key Trial Info
Start Date :
July 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06357442
Start Date
July 1 2024
End Date
July 1 2026
Last Update
December 6 2024
Active Locations (1)
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1
Childrens Hospital Colorado
Aurora, Colorado, United States, 80045