Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07107334 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia

StatusRecruiting
PhasePhase 2
Started2026-04-07
View on ClinicalTrials.gov ↗

Amendment history

2026-06-04
Study Status, Arms and Interventions, Eligibility v5
Eligibility criteria+129 characters
Inclusion Criteria: Adults ≥ 18 years old A pathological diagnosis with in the past 34 months consistent with grade 1 endometrioid endometrial adenocarcinoma or endometrial intraepithelial neoplasiaEIN For subjects with a diagnosis of endometrial intraepithelia [...] re enrollment acceptance. ECOG Performance Status of 0 to 3 NoFor those with endometrial cancer, no extrauterine involvement or myometrial invasion by MRI (preferred) or transvaginal ultrasound with in the last 3 months BMI ≥ 30 kg/m2 and one of the following (per medical record [...] ior to study enrollment, as documented in the medical record [...]
2026-04-08
Study Status, Contacts/Locations v4
Start dateestimated 2026-03→confirmed 2026-04-07
Study sitescontacts updated at 1 of 1 site
2026-03-17
Study Status, Study Design, Arms and Interventions v3
Enrollment target30→20
2026-02-16
Not Yet Recruiting→Recruiting Study Identification, Study Status, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
Eligibility criteria+703 characters
[...] ial adenocarcinoma or endometrial intraepithelial neoplasia For subjects with a diagnosis of endometrial intraepithelial neoplasia/grade 1 endometrioid endometrial adenocarcinoma prior to enrollment in the study, and with a diagnosis made outside this institution, the diagnostic material originating from outside the study site will undergo in-house pathology [...] ECOG Performance Status of 0 to 3 No extrauterine involvemen [...] in the last 3 months BMI ≥ 30 kg/m2 and one of the following (per medical record or self-report): Multiple medical co-morbidities (defined as American Socie [...] s [ASA] score ≥ 3) at ph [...]
2025-12-11
Study Status v1
Start date2025-11→2026-03
2025-07-30
Original filing
This study will explore the use of glucagon-like peptide 1 receptor agonist (GLP-1RA) used concurrently with levonorgestrel intrauterine device in patients with poor surgical candidacy for a hysterectomy or patients who are pursuing fertility sparing. GLP-1RA are a class of medications that mimic the natural hormone glucagon-like peptide-1. These medications trigger the pancreas to release insulin which can help lower blood sugar levels and delay gastric emptying. The recent FDA approval of GLP-1RAs has changed the landscape for pharmacotherapy for weight loss. These hormone-based obesity medications are novel and revolutionary in obesity medicine. Liraglutine, semaglutide, and tirzepatide have become exceedingly popular for their effects on weight loss and obesity-related comorbidities. More recently, GLP-1RAs have exhibited risk reduction of various obesity associated cancers, including endometrial cancer but their exact role in prevention and treatment has yet to be measured.
Trial Details
NCT Number NCT07107334
Lead Sponsor University of Florida
Conditions Endometrioid Endometrial Adenocarcinoma
Enrollment 20 participants
Start Date 2026-04-07
Primary Completion 2028-11 (estimated)
Study Completion 2029-11 (estimated)
Updated on ClinicalTrials.gov 2026-06-08