Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Low-grade Cancer of the Endometrium

Sponsor
University Health Network, Toronto
Study ID
NCT06073184
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 41 Years
Healthy Volunteers
Not accepted

Interventions

  • Mounjaro — DRUG
    Weekly subcutaneous injection of 2.5mg tirzepatide at baseline with dose escalation by 2.5mg every 4 weeks to reach 15mg or the maximum tolerated dose, by Week 20
  • Mirena — DRUG
    Levonorgestrel-releasing Intrauterine System (52mg) to deliver up to 20 mcg levonorgestrel per day

Study Details

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.

Key Dates

Start date
Aug 31, 2025
Status verified
Jun 2025
Primary completion
Feb 28, 2027
Completion
Feb 29, 2032

Study Design

Enrollment
71 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide and Progestin Intrauterine Device
    All patients will receive a progestin intrauterine device and tirzepatide subcutaneous injections

Primary Outcome Measure

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

Central Contacts

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