NCT05316467TerminatedPhase 2/3
Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma
Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma: Two Single-arm, Prospective and Open-label Clinical Study
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Reason given: no enough enrolled patients
Brief summary (registry, in English)
To investigate the efficacy of weight management plus megestrol acetate in obese patients with early endometrioid carcinoma(EEC)asking for fertility-sparing treatment
- Status (registry)
- Terminated
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 9 Mar 2022
- Start date
- 1 May 2022
- Primary completion date
- 28 Feb 2026
- Lead sponsor
- Xiaojun Chen
- Diseases
- Endometrial cancer, Obesity
- NCT number
- NCT05316467
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 have received high doses of high potency progestin or oral contraceptives within the last 3 months (or those on maintenance medication).
Other illness
- Patients with non-endometrioid endometrial carcinoma, endometrioid endometrial carcinoma G2/G3 or other malignant tumors of the reproductive system; imaging suggests myometrial invasion, cervical involvement or extra-uterine involvement.
- 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.
- Deep vein thrombosis, stroke, myocardial infarction.
Lab values
- Combined with severe medical disease or liver or kidney dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels elevate to 3 times or more of the upper limit of normal, kidney dysfunction (creatinine clearance <30 mL/min)
Other
- Those who require hysterectomy or other methods other than conservative treatment.
- Known or suspected pregnancy.
- Those who has contraindications to use progestin.
- Severe joint lesions that prevent walking or movement.
Who the study is looking for
- 18 years≤age≤45years
- BMI (body mass index) ≥24kg/m2
- Consent informed and signed
- Pathologically confirmed as endometrial carcinoma Patients with endometrial specimens obtained by endometrial biopsy, diagnostic curettage or hysteroscopy and diagnosed histologically as endometrioid carcinoma, G1. If specimens are from other hospitals, they must be counseled or reconfirmed by the Department of Pathology of the Obstetrics and Gynecology Hospital of Fudan University.
- Imaging Assessment Enhanced MRI of the pelvis and enhanced CT of the upper abdomen must be performed in 2 weeks prior to starting treatment to assess the lesions confined to the endometrial layer without clear myometrial infiltration or extrauterine involvement.
- 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 and Gynecology Hospital, Fudan University | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.