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RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Glucagon-like peptide 1 receptor agonist for Endometrioid Endometrial Adenocarcinoma

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.

Official registry: https://clinicaltrials.gov/study/NCT07107334 · University of Florida · enrollment listed as 20

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Glucagon-like peptide 1 receptor agonist. The registry lists allocation as na. 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.

They plan to enroll about 20 people at Gainesville. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Pilot Study to Estimate Early Clinical Efficacy Signals of a Glucagon-like Peptide 1 Receptor Agonist (GLP-1RA) Administration in Conjunction With Levonorgestrel Intrauterine Device (LNG-IUD) in Obese Patients With Endometrioid Intraepithelial Neoplasia

Interventions: Glucagon-like peptide 1 receptor agonist

Primary outcome (registry wording): Time from start of GLP-1RA to clearance of staging hysterectomy

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Women only
  • Adults ≥ 18 years old
  • A pathological diagnosis with in the past 4 months consistent with grade 1 endometrioid endometrial adenocarcinoma or EIN
  • how well you can do daily activities (ECOG score) of 0 to 3
  • For those with endometrial cancer, no extrauterine involvement or myometrial invasion by MRI (preferred) or transvaginal ultrasound
  • body-mass index (BMI) ≥ 30 kg/m2 and one of the following (per medical record or self-report):
  • Multiple medical co-morbidities (defined as American Society of Anesthesiologists \[ASA\] score ≥ 3) at physician discretion
  • Subject has had appropriate age-related breast examinations and imagining prior to study enrollment, as documented in the medical record or via investigator confirmation

Public study contact (from the registry)

Amber N Batie

(352) 273-8457

amberbatie@ufl.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07107334 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07107334?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07107334?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary