Actively Recruiting
Led by University of Colorado, Denver · Updated on 2024-12-06
34
Participants Needed
1
Research Sites
N/A
Total Duration
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
Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant.
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants complete a baseline survey and undergo a transabdominal pelvic ultrasound to measure endometrial thickness before starting progesterone therapy.
1 visit (in-person) for ultrasound and survey
Duration - 6 months
Participants begin their selected progesterone therapy: daily oral micronized progesterone or etonogestrel implant, and continue therapy for 6 months.
1 clinic visit for implant insertion or prescription; ongoing daily oral medication for oral progesterone group
Duration - 6 months (concurrent with treatment)
Participants complete brief questionnaires at 3 and 6 months after starting progesterone therapy to report bleeding patterns, side effects, satisfaction, and adherence. A second pelvic ultrasound is performed at 6 months to measure endometrial thickness.
2 questionnaire timepoints (remote or in-person), 1 in-person ultrasound visit at 6 months
Total: 1 location
1
Childrens Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
J
Julie C Friedman, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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