Recruiting
Phase 2

pIUD with Weight-Loss Drug

Sponsor:

GynOncTrials

Code:

NCT06073184

Conditions

Endometrial Cancer

Atypical Hyperplasia

Fertility Perservation

Eligibility Criteria

Sex: Female

Age: 18 - 41

Healthy Volunteers: Not accepted

Interventions

Wegovy

Mirena

Study Details

Brief summary:

The incidence of endometrial cancer is increasing at an alarming rate. This trend parallels the rising rate of obesity, the most significant risk factor for endometrial cancer. Young women with obesity and endometrial cancer or atypical hyperplasia who want to maintain their fertility are treated with progestin therapy, such as progestin intra-uterine device (pIUD), which is associated with a mediocre response rate and high recurrence rate, and does not address the underlying cause, obesity. Therefore, the investigators want to assess whether the addition of a weight-loss drug to pIUD will improve their oncologic, reproductive and metabolic outcomes.

Conditions

Endometrial Cancer

Atypical Hyperplasia

Fertility Perservation

Study ID

NCT06073184

Start date

Sep 17, 2026

Status verified date

Sep, 2026

Completion date

Feb, 2032

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 41

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • BMI ≥ 27
  • Diagnosis of grade 1 endometrioid endometrial cancer or atypical hyperplasia made by either endometrial biopsy or dilation and curettage
  • For those with endometrial cancer, clinical FIGO 2009 stage 1A disease without evidence of metastatic disease beyond the uterus and no myometrial invasion by MRI or CT
  • ECOG status <2
  • Desire for fertility preservation
  • Ability to understand and willing to sign a written informed consent document

Exclusion Criteria:

  • Evidence of myometrial invasion or extra-uterine disease on imaging
  • High grade or p53 mutated (p53mut) endometrial cancer
  • Estrogen receptor negative endometrial cancer (positivity defined as moderate/strong staining>10%)
  • Mismatch repair deficient (MMRd) endometrial cancer
  • History of other malignancies except if curatively treated with no evidence of disease for >5 years
  • Previous surgical treatment of obesity
  • Current use of weight loss medication (no use in last 2 months)
  • Medical comorbidity with end-organ dysfunction
  • History of suicide attempts or current suicidal thoughts or behaviours
  • Currently taking insulin or insulin secretagogue (e.g., sulfonylurea)
  • Diabetic retinopathy
  • Gastroparesis or problems with food digestion
  • History of tachycardia (e.g., sinus tachycardia, supraventricular tachycardia, atrial fibrillation, atrial flutter, or ventricular tachycardia)
  • Contraindications to pIUD or semaglutide.

  • Hypersensitive to WEGOVY or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container
  • Personal or family history of medullary thyroid carcinoma (MTC)
  • Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • Pregnant or breast-feeding
  • Current or recurrent pelvic inflammatory disease
  • Lower genital tract infection
  • Postpartum endometritis
  • Uterine anomalies including fibroids if they distort the uterine cavity
  • Cervical malignancy
  • Known or suspected progestin-dependent neoplasia, including breast cancer
  • Cervicitis
  • Untreated cervical dysplasia
  • Active liver disease or dysfunction
  • Actual benign or malignant liver tumors
  • Sceptic abortion within the previous three months
  • Hypersensitivity to levonorgestrel or any of the other ingredients in the formulation or components of MIRENA.
  • Bacterial endocarditis
  • Established immunodeficiency
  • Acute malignancies affecting blood or leukemias
  • Recent trophoblastic disease while hCG levels are elevated
  • Previously inserted intrauterine device (IUD) that has not been removed
  • Conditions associated with increased susceptibility to pelvic infections
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.

Study Design

Enrollment

71 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Semaglutide and Progestin Intrauterine Device

All patients will receive a progestin intrauterine device and semaglutide subcutaneous injections

Interventions

Wegovy

Weekly subcutaneous injection of 0.25 mg semaglutide at baseline with dose escalation every 4 weeks to reach 2.4 mg or the maximum tolerated dose, by Week 16

Mirena

Levonorgestrel-releasing Intrauterine System (52mg) to deliver up to 20 mcg levonorgestrel per day

Primary outcome measure

  • Assessment of Complete Pathologic Response [ Time Frame: 48 weeks ]

Central Contacts and Locations

Central contacts

Vanessa Ballin

416-946-4501vanessa.ballin@uhn.ca

Locations

Princess Margaret Cancer Centre, University Health Network

Recruiting

Toronto, Ontario, Canada

More Information

Sponsor

GynOncTrials

Last update posted

Oct 5, 2026

Last verified

Sep, 2026

Keywords

  • pIUD
  • semaglutide
  • WEGOVY
  • atypical hyperplasia
  • endometrial cancer
  • fertility preservation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by GynOncTrials on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.