NCT05172999CompletedPhase 2/3
Loxenatide Plus LNG-IUS in Endometrial Atypical Hyperplasia
A Randomized Controlled Pilot Study of Polyethylene Glycol Loxenatide Plus LNG-IUS in Women With Endometrial Atypical Hyperplasia
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
To study if polyethylene glycol loxenatide plus levonorgestrel-releasing intrauterine system (LNG-IUS) will improve response rates in patients with endometrial atypical hyperplasia.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 12 Dec 2021
- Start date
- 8 Jan 2022
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Fudan University
- Diseases
- Obesity
- NCT number
- NCT05172999
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 30
- From 8 Jan 2022 to the primary completion date, 30 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those who require hysterectomy or other methods other than conservative treatment with drugs
Other illness
- Diagnosed as type 2 diabetes
- 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
- Currently suffering from pelvic inflammatory disease or diagnosed as pelvic inflammatory disease
- Lower reproductive system infection
- 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 falling off
Other
- Diabetic ketoacidosis
- Known or suspected pregnancy
- abnormal cervical dysplasia
- Congenital or acquired uterine abnormalities, including fibroids that deform the uterine cavity
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Obstetrics&Gynecology Hospital of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.