Endometrial Cancer study: Wegovy vs Mirena
Official title Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Low-grade Cancer of the Endometrium
ClinicalTrials.gov ID: NCT06073184
What this study is testing
What is Wegovy?
This is an investigational weekly injection being studied to help treat endometrial cancer in patients who want to keep their fertility. It is designed to help the body manage blood sugar and reduce appetite to promote weight loss.
Also referred to as Semaglutide.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if combining a weight-loss medication with a standard hormone treatment improves health and fertility outcomes for women with early uterine issues.
- Who it's for
- The study is looking for young women who have obesity and either early uterine cancer or abnormal uterine cell growth, and who wish to preserve their ability to have children.
- What's involved
- Participants will receive a hormone-releasing device placed in the uterus and take a weight-loss medication. They will undergo regular medical tests to monitor their condition.
- Time commitment
- The source text does not specify the total duration of the study or the exact number of required visits.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 41, women only
You may be able to join if
- 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...
- ECOG status \<2
- Desire for fertility preservation
You likely can't join if
- 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 41 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.