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

Launched by UNIVERSITY OF COLORADO, DENVER · Apr 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how different types of progesterone therapy affect the thickness of the endometrium (the lining of the uterus) in adolescent and young adult females who are receiving estrogen replacement therapy. The goal is to compare the effects of daily oral micronized progesterone (Prometrium) versus the etonogestrel implant (Nexplanon) over a six-month period. Researchers want to find out how thick the endometrial lining is before starting progesterone and how it changes with each treatment. They will also look at participants' satisfaction, any side effects, bleeding patterns, and how well they stick to the treatment plan.

To be eligible for this study, participants need to be between 12 and 25 years old, assigned female at birth, and have certain medical conditions like primary ovarian insufficiency or hypogonadotropic hypogonadism, which require them to take estrogen. They must have been on estrogen for at least three months and have not used progesterone therapy in the recent past. If they join the study, participants will have two pelvic ultrasounds, complete two surveys, continue their estrogen therapy, and start one of the two progesterone treatments. This trial is currently recruiting participants, so if you think you might qualify, it could be a great opportunity to contribute to important research in this area.

Gender

FEMALE

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