## Protocol Section
### Identification Module
**NCT ID:** NCT06417736

**Brief Title:** Prospective Study for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women

**Official Title:** Prospective Clinical Study of Fertility-sparing Treatment With a Membrane-inhibiting Formula Combined With Oral Progestins for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women

#### Organization Study ID Info
**ID:** PRO2023-3614
#### Organization
**Class:** OTHER
**Full Name:** Women's Hospital School Of Medicine Zhejiang University
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-07-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-12-01

**Type:** ACTUAL

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Women's Hospital School Of Medicine Zhejiang University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The goal of this clinical trial is to evaluate the effect and adverse side effects of membrane-inhibiting formula plus oral progestins as fertility-preserving treatment in patients with early-stage endometrial cancer and endometrial hyperplasia research questions：When taken with oral progestins, does the drug membrane-inhibiting formula shorten the time required for complete endometrial remission? What medical problems do participants have when taking drug membrane-inhibiting formula plus oral progestins? Efficacy, side effects, recurrence, pregnancy, and time to obtain pregnancy in different molecular classifications of POLE-mutated, mismatch repair-deficient(MMRd), p53 wild type(p53wt), and p53-abnormal(p53abn).

Participants will: Take drug membrane-inhibiting formula plus oral progestins every day Visit the clinic once every 3 months for checkups, tests, and hysteroscopy Keep a diary of examination results and pathology

### Conditions Module

**Conditions:**

- Endometrial Cancer Stage I

- Endometrial Hyperplasia

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 75

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Megestrol acetate(160mg/day) and membrane-inhibiting formula, 24weeks

**Intervention Names:**

- Drug: Megestrol Acetate 40 MG

**Label:** membrane-inhibiting formula combined with oral progestins

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- membrane-inhibiting formula combined with oral progestins

**Description:** 160mg/one time/day

**Name:** Megestrol Acetate 40 MG

**Other Names:**

- membrane-inhibiting formula

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** Efficacy in different molecular classification of POLE-mutated, mismatch repair-deficient(MMRd), p53 wild type(p53wt),and p53-abnormal(p53abn)

**Measure:** CR in different molecular classification

**Time Frame:** baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment

#### Primary Outcomes

**Description:** The treatment response:complete response,no endometrial lesion

**Measure:** 24-week complete response(CR) rate

**Time Frame:** baseline,12 weeks after treatment,and 24 weeks of treatment

#### Secondary Outcomes

**Description:** The treatment response:complete response,no endometrial lesion

**Measure:** 36-week CR rate

**Time Frame:** baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment

**Description:** The treatment response:complete response,no endometrial lesion

**Measure:** 48-week CR rate

**Time Frame:** baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment

**Description:** analyze the safety of the drug

**Measure:** treatment-related adverse events

**Time Frame:** baseline,12 weeks after treatment,and 24 weeks of treatment

**Description:** cumulative recurrent rate

**Measure:** recurrent rate

**Time Frame:** baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment

**Description:** long term fertility results

**Measure:** pregnancy rate

**Time Frame:** 1-year after CR

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 1.18-45 years old with a strong desire to preserve fertility; 2. pathologically diagnosed with primary grade1 or grade2 endometrioid endometrial carcinoma and hyperplasia 3.no signs of suspicious myometrial invasion by enhanced magnetic resonance imaging (MRI) 4. no signs of suspicious extrauterine metastasis by enhanced computed tomography and CT scan of the Lungs

Exclusion Criteria:

* 1.have contraindication for pregnancy. 2.no fertility requiremen 3.have myometrial invasion or extrauterine metastasis 4.pathologically diagnosed with primary grade3 endometrioid endometrial carcinoma or non-endometrioid endometrial carcinoma 5.Any disease or symptom that may affect the implementation of the study or the interpretation of the results

**Gender Based:** True

**Gender Description:** female

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** 5516015@zju.edu.cn

**Name:** Yang Li, Doctor

**Phone:** 0086-18268165386

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hangzhou

**Contacts:**

***Contact 1:***

- **Email:** 5516015@zju.edu.cn

- **Name:** Li Yang

- **Phone:** 0086-18268165386

- **Role:** CONTACT

**Country:** China

**Facility:** Women's Hospital School of Medicine Zhejiang University

**State:** Zhejiang

**Status:** RECRUITING

**Zip:** 321006

#### Overall Officials

**Official 1:**

**Affiliation:** Women's Hospital School Of Medicine Zhejiang University

**Name:** Yang Li, Doctor

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000014594

- Term: Uterine Neoplasms

- ID: D000005833

- Term: Genital Neoplasms, Female

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000014591

- Term: Uterine Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M10016

- Name: Hyperplasia

- Relevance: HIGH

- As Found: Hyperplasia

- ID: M7876

- Name: Endometrial Hyperplasia

- Relevance: HIGH

- As Found: Endometrial Hyperplasia

- ID: M19235

- Name: Endometrial Neoplasms

- Relevance: HIGH

- As Found: Endometrial Carcinoma

- ID: M17342

- Name: Uterine Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8945

- Name: Genital Neoplasms, Female

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17339

- Name: Uterine Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016889

- Term: Endometrial Neoplasms

- ID: D000004714

- Term: Endometrial Hyperplasia

- ID: D000006965

- Term: Hyperplasia

### Intervention Browse Module - Ancestors

- ID: D000003278

- Term: Contraceptives, Oral, Hormonal

- ID: D000003276

- Term: Contraceptives, Oral

- ID: D000003271

- Term: Contraceptive Agents, Female

- ID: D000003270

- Term: Contraceptive Agents

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000080066

- Term: Contraceptive Agents, Hormonal

- ID: D000003280

- Term: Contraceptives, Oral, Synthetic

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000019167

- Term: Appetite Stimulants

- ID: D000000697

- Term: Central Nervous System Stimulants

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CNSSti

- Name: Central Nervous System Stimulants

### Intervention Browse Module - Browse Leaves

- ID: M11518

- Name: Megestrol

- Relevance: HIGH

- As Found: Nor

- ID: M21272

- Name: Megestrol Acetate

- Relevance: HIGH

- As Found: EPI

- ID: M14244

- Name: Progestins

- Relevance: LOW

- As Found: Unknown

- ID: M6494

- Name: Contraceptive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M6500

- Name: Contraceptives, Oral

- Relevance: LOW

- As Found: Unknown

- ID: M6502

- Name: Contraceptives, Oral, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M6495

- Name: Contraceptive Agents, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2116

- Name: Contraceptive Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M4029

- Name: Central Nervous System Stimulants

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008535

- Term: Megestrol

- ID: D000019290

- Term: Megestrol Acetate

### Misc Info Module

- Version Holder: 2024-05-31
