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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Childrens Hospital Colorado

Aurora, Colorado, United States, 80045