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Observational Study of Progesterone for Endometrial Protection

This observational study is looking at how well two different progesterone treatments protect the lining of the uterus (endometrial thickness) in young women. You might be eligible if you are 12-25 years old, were assigned female at birth, have a uterus, and are on estrogen replacement therapy for conditions like primary ovarian insufficiency or hypogonadotropic hypogonadism. The study compares daily oral micronized progesterone (Prometrium) with the etonogestrel implant (Nexplanon). Researchers want to see how endometrial thickness changes after 6 months of using either treatment. They also want to understand your satisfaction, side effects, and bleeding patterns. The study is currently unclear on its status and plans to enroll 34 participants.

Study design
This is a prospective, observational pilot study involving 34 participants. You would self-select into one of two groups: daily oral micronized progesterone or the etonogestrel implant.
What's involved
You would be followed for 6 months to assess changes in endometrial thickness and other factors. Providers will identify eligible patients at routine appointments.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured after 6 months of progesterone therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06357442

Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant.

Recruiting
Not specifiedAges 12–25Observational
University of Colorado, Denver
~34 participants
Updated 2024-12-06 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean change in endometrial thickness after 6 months of progesterone therapy
Measured over 6 months

Conditions

Primary Ovarian Insufficiency
Hypogonadotropic Hypogonadism
Hormone Replacement Therapy

Explore related trials

Hypogonadotropic HypogonadismPrimary Ovarian Failure

Where it's being run

1 sites across 1 states
Colorado1

Who to contact

Julie C Friedman, MD
[email protected]
720-777-2667
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Mean change in endometrial thickness after 6 months of progesterone therapy6 months

    Measure the mean change and variability in endometrial thickness (mm) in AYA treated for 6 months with either the etonogestrel implant or continuous oral progesterone via transabdominal pelvic ultrasound.