What is this study trying to find out about hormone replacement therapy?

This study is exploring how two types of progesterone treatments affect the thickness of the uterine lining in adolescent and young adult females on estrogen replacement therapy. Researchers want to understand differences in endometrial thickness, bleeding patterns, side effects, and treatment adherence. The University of Colorado, Denver is leading this study to help improve care in this patient group.

Who may be eligible for this hormone replacement therapy clinical trial?

Females assigned at birth aged 12 to 25 years with a uterus, diagnosed with primary ovarian insufficiency or hypogonadotropic hypogonadism, and on estradiol therapy for at least 3 months may be eligible. Participants must not be currently on progesterone or have stopped it at least 90 days prior and must agree to start progesterone therapy. Please review eligibility criteria for more details.

Is there any cost to participate in this hormone replacement therapy clinical trial?

Study-related care, including ultrasounds and surveys, is provided at no cost. However, personal travel or other expenses to attend study visits may not be covered and can vary for each participant.

Actively Recruiting

Age: 12Years - 25Years

FEMALE

ID06357442

Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Continuous Oral Micronized Progesterone Versus the Etonogestrel Implant a Prospective Pilot Study

Led by University of Colorado, Denver · Updated on 2024-12-06

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to compare the thickness of the endometrial lining in adolescent and young adult females on estrogen replacement therapy using two types of progesterone treatments daily oral micronized progesterone and the etonogestrel implant. The study focuses on patients aged 12 to 25 years with specific diagnoses requiring estrogen therapy, addressing gaps in knowledge about endometrial protection and bleeding patterns in this group. Participants will choose between two progesterone therapies oral micronized progesterone taken daily at 100mg or the etonogestrel implant placed in a clinic. The study will last six months, during which participants will continue their estrogen therapy and start their selected progesterone treatment. Two pelvic ultrasounds will be performed, one at the start and one after six months of progesterone use, to measure changes in endometrial thickness. Throughout the study, participants will complete surveys about bleeding patterns, side effects, satisfaction, and adherence to their progesterone treatment. The study team will track medication use through pill counts or photos for those on oral progesterone. All ultrasound and survey data will be securely stored and analyzed to assess the mean change in endometrial thickness and other patient-reported outcomes over six months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 12Years - 25Years

FEMALE

Eligibility Criteria

You may qualify if you...

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 orally (1-2mg) or transdermally (0.05-0.1mg) for at least 3 months
Never used progesterone therapy or stopped it at least 90 days prior to enrollment
Willing to start progesterone therapy

You will not qualify if you...

Uterine abnormalities such as M�fcllerian anomaly or uterine fibroids
Unable to clearly measure the endometrial lining on ultrasound
History of chemotherapy or radiation therapy
Unable to complete study questionnaires

Research Team

Julie C Friedman, MD

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