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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Obstetrics and Gynecology Hospital, Fudan UniversityShanghaiChinaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.