RECRUITING

Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators hypothesize that combined treatment with the GLP-1R agonist semaglutide 2.4 mg and levonorgestrel intrauterine device (LNG-IUD), compared to LNG-IUD alone, will result in improved likelihood of uterine preservation, sustained weight loss, improved endometrial and metabolomic response to progestin, and improved quality of life in premenopausal women with endometrial hyperplasia who desire uterine preservation.

Official Title

Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia

Quick Facts

Study Start:2025-04-30

Study Completion:2032-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05829460

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Diagnosis of histologically confirmed complex atypical endometrial hyperplasia. * Patients with a previous diagnosis of AEH who are already being followed with conservative management with oral or LNG-IUD progestin therapy are eligible provided they have not previously been on a GLP-1R agonist within 3 months prior to enrollment. * For patients with a previous diagnosis of AEH who have been placed on progestin prior to study entry, the duration of IUD or oral progestin use prior to trial entry should be less than or equal to 6 months. * Premenopausal woman with a uterus. * At least 18 years of age and no more than 45 years of age. * Interested in uterine preservation/fertility-sparing treatment. * BMI ≥ 30 kg/m2. * Prior or current receipt of progestin is allowed as above. Willingness to undergo placement of LNG-IUD at the time of study entry. * Prior or current receipt of metformin is allowed. * Ability to understand and willingness to sign an IRB approved written informed consent document.	* Prior use of GLP-1 receptor agonist (exenatide, liraglutide, or other) or pramlintide or any DPP-4 inhibitor in the 3 months prior to date of registration. * History of type 1 or type 2 diabetes, and/or the following biochemical indications: fasting plasma glucose ≥ 126 mg/dL, HbA1c ≥ 6.5%, two-hour plasma glucose ≥ 200 mg/dL during an oral glucose tolerance test (OGTT), or random glucose ≥ 200 mg/dL in the presence of symptoms * Acute decompensation of glycemic control. * Concomitant use of other weight management drugs or drugs for short-term weight loss. * History of surgery or use of a device to treat obesity. * Uncontrolled thyroid disease * Acute coronary or cerebrovascular event in the previous 60 days. * Currently planned coronary, carotid, or peripheral artery revascularization. * Chronic heart failure (NYHA class IV). * Evidence of renal dysfunction as defined by creatinine clearance \< 60 ml/minute. * History of solid organ transplant or awaiting solid organ transplant. * Diagnosis of any malignant neoplasm or current, active treatment with chemotherapy or radiation. * Family or personal history of multiple endocrine neoplasia syndrome type 2 (MEN 2) or familial medullary thyroid carcinoma (MTC). * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to progestin, semaglutide, or other agents used in the study. * History of diabetic retinopathy. * Recent history of pancreatitis, defined as less than 6 months prior to enrollment. * History of suicidal attempts or active suicidal ideation. * Significant active psychiatric disease, including recent psychiatric inpatient admission or use of any psychiatric medications that are not stabilized. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. * Pregnant and/or breastfeeding. Participants must have a negative serum pregnancy test within 7 days of date of registration. * Patients with HIV are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL, they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration, or they are receiving anti-retrovirals that affect progestin levels. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.

Inclusion Criteria

Exclusion Criteria

* Diagnosis of histologically confirmed complex atypical endometrial hyperplasia.
* Patients with a previous diagnosis of AEH who are already being followed with conservative management with oral or LNG-IUD progestin therapy are eligible provided they have not previously been on a GLP-1R agonist within 3 months prior to enrollment.
* For patients with a previous diagnosis of AEH who have been placed on progestin prior to study entry, the duration of IUD or oral progestin use prior to trial entry should be less than or equal to 6 months.
* Premenopausal woman with a uterus.
* At least 18 years of age and no more than 45 years of age.
* Interested in uterine preservation/fertility-sparing treatment.
* BMI ≥ 30 kg/m2.
* Prior or current receipt of progestin is allowed as above. Willingness to undergo placement of LNG-IUD at the time of study entry.
* Prior or current receipt of metformin is allowed.
* Ability to understand and willingness to sign an IRB approved written informed consent document.

* Prior use of GLP-1 receptor agonist (exenatide, liraglutide, or other) or pramlintide or any DPP-4 inhibitor in the 3 months prior to date of registration.
* History of type 1 or type 2 diabetes, and/or the following biochemical indications: fasting plasma glucose ≥ 126 mg/dL, HbA1c ≥ 6.5%, two-hour plasma glucose ≥ 200 mg/dL during an oral glucose tolerance test (OGTT), or random glucose ≥ 200 mg/dL in the presence of symptoms
* Acute decompensation of glycemic control.
* Concomitant use of other weight management drugs or drugs for short-term weight loss.
* History of surgery or use of a device to treat obesity.
* Uncontrolled thyroid disease
* Acute coronary or cerebrovascular event in the previous 60 days.
* Currently planned coronary, carotid, or peripheral artery revascularization.
* Chronic heart failure (NYHA class IV).
* Evidence of renal dysfunction as defined by creatinine clearance \< 60 ml/minute.
* History of solid organ transplant or awaiting solid organ transplant.
* Diagnosis of any malignant neoplasm or current, active treatment with chemotherapy or radiation.
* Family or personal history of multiple endocrine neoplasia syndrome type 2 (MEN 2) or familial medullary thyroid carcinoma (MTC).
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to progestin, semaglutide, or other agents used in the study.
* History of diabetic retinopathy.
* Recent history of pancreatitis, defined as less than 6 months prior to enrollment.
* History of suicidal attempts or active suicidal ideation.
* Significant active psychiatric disease, including recent psychiatric inpatient admission or use of any psychiatric medications that are not stabilized.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
* Pregnant and/or breastfeeding. Participants must have a negative serum pregnancy test within 7 days of date of registration.
* Patients with HIV are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL, they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration, or they are receiving anti-retrovirals that affect progestin levels. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.

Contacts and Locations

Study Contact

Andrea R Hagemann, M.D., MSCI

CONTACT

314-362-1763

hagemanna@wustl.edu

Principal Investigator

Andrea R Hagemann, M.D., MSCI

PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Andrea R Hagemann, M.D., MSCI, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-30

Study Completion Date2032-04-30

Study Record Updates

Study Start Date2025-04-30

Study Completion Date2032-04-30

Terms related to this study

Additional Relevant MeSH Terms

Endometrial Hyperplasia