Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial H… (NCT05829460) | Clinical Trial Compass
WithdrawnPhase 2
Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia
Stopped: Low accrual
0Started 2025-03-12
Plain-language summary
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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of histologically confirmed non-atypical endometrial hyperplasia (EH) or complex atypical endometrial hyperplasia (AEH).
* Patients with a previous diagnosis of EH or 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 EH or 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.
Exclusion Criteria:
* 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 diabetes.
* History of type 2 diabetes requiring use of insulin.
* Acute decompensation of glycemic control.
* Concomitant use of other weight management drugs or drugs for short-term weight loss.
* His…
What they're measuring
1
Number of patients with endometrial hyperplasia free biopsy with uterine preservation