Comparing progesterone options for endometrial protection in young women on estrogen therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to compare endometrial thickness in adolescent and young adult patients on estrogen replacement therapy who are treated with either oral micronized progesterone or the etonogestrel implant. Participants will undergo two pelvic ultrasounds and complete surveys to assess satisfaction, side effects, and adherence to the treatment. The study will characterize endometrial thickness before and after six months of treatment, providing insights into the effectiveness of these progesterone therapies for endometrial protection. The study is being conducted at Children's Hospital Colorado, where eligible patients will be recruited from various clinics.

Why it matters

Who can join: the full rules

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

Where it's running

• Childrens Hospital Colorado
  Aurora, Colorado, United States Recruiting

Study contacts

• Study coordinator: Julie C Friedman, MD
• Email: julie.friedman@cuanschutz.edu
• Phone: 720-777-2667

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.