Loxenatide Plus LNG-IUS in Endometrial Atypical Hyperplasia (NCT05172999) | Clinical Trial Compass
CompletedPhase 2/3
Loxenatide Plus LNG-IUS in Endometrial Atypical Hyperplasia
China30 participantsStarted 2022-01-08
Plain-language summary
To study if polyethylene glycol loxenatide plus levonorgestrel-releasing intrauterine system (LNG-IUS) will improve response rates in patients with endometrial atypical hyperplasia.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion Criteria:
* BMI (body mass index) ≥28kg/m2
* Consent informed and signed
* Pathologically confirmed as endometrial atypical hyperplasia
* Have a strong desire to reproduce and ask for fertility preservation or those who insist on keeping the uterus despite no reproductive requirements
* Have good compliance and follow-up conditions, and patients are willing to follow up in Obstetrics and Gynecology Hospital of Fudan University in time
Exclusion Criteria:
* Diagnosed as type 2 diabetes
* Diabetic ketoacidosis
* History of acute pancreatitis
* Have a history or family history of medullary thyroid carcinoma; multiple endocrine neoplasia syndrome type 2 (MEN2)
* Combined with severe medical disease or severely impaired liver and kidney function
* Patients with other types of endometrial cancer or other malignant tumors of the reproductive system; patients with breast cancer or other hormone- dependent tumors that cannot be used with progesterone
* Those who require hysterectomy or other methods other than conservative treatment with drugs
* Known or suspected pregnancy
* Currently suffering from pelvic inflammatory disease or diagnosed as pelvic inflammatory disease
* Lower reproductive system infection
* abnormal cervical dysplasia
* Congenital or acquired uterine abnormalities, including fibroids that deform the uterine cavity
* Allergic to any parts of LNG-IUS components
* The uterine cavity is too large (average diameter is over 7cm) or the history of LNG-IUS fal…
What they're measuring
1
Pathological complete response (CR) rates
Timeframe: From date of randomization until the date of CR, assessed up to 32 weeks.