Comparing progesterone options for endometrial protection in young women on estrogen therapy
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
This study is testing whether oral progesterone or a hormone implant is better at protecting the uterus in young women who are taking estrogen therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 34 (estimated) |
| Ages | 12 Years to 25 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06357442 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are females aged 12-25 with primary ovarian insufficiency or hypogonadotropic hypogonadism who require estrogen replacement therapy.
Not a fit: Patients with uterine abnormalities or those who have undergone chemotherapy or radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the most effective progesterone therapy for endometrial protection in young women undergoing hormone replacement therapy.
How similar studies have performed: While similar studies have explored hormone replacement therapies, this specific comparison of progesterone options in this age group is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.