Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia

NCT05675787 | Recruiting Phase 2 DMC

• 1 other identifier: 2022PHB416
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the treatment efficacy of medroxyprogesterone acetate plus atorvastatin in patients with atypical endometrial hyperplasia (AEH) and early endometrial carcinoma (EEC) for conservative treatment.

Conditions

Atypical Endometrial Hyperplasia; Endometrial Carcinoma Stage I

Keywords

Endometrial Carcinoma; Atypical Endometrial Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Pathological cumulative complete response rate;

  3 to 4 months: From date of initial therapy until the date of CR or date of hysterectomy,

  assessed up to 4 months

Secondary Outcomes (7)

• Pathological cumulative complete response rate;

  assessed up to 8 months

• The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue

  assessed up to 4 months

• Overall complete response rate

  up to 2 years

• Pathological response rate classified by different blood lipid level

  up to 2 years;

• Relapse rate

  up to 15 months after the end of treatment

Study Arms (2)

Experimental group

EXPERIMENTAL

MPA + Atorvastatin

Drug: Medroxyprogesterone acetate + Atorvastatin

Control groups

NO INTERVENTION

MPA

Interventions

Medroxyprogesterone acetate + Atorvastatin DRUG

MPA (at a dosage of 250-500 mg/day,) + Atorvastatin (at a dosage of 20 mg/day), by mouth,

Experimental group

Eligibility Criteria

• Age: 17 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Have a confirmed pathological diagnosis based upon hysteroscopy: histologically prove AEH or well-differentiated EEC G1 without myometrial invasion: 1. Untreated patients; 2. Patients with persistent lesions after one course (12 weeks) of progesterone therapy; 3. Patients who did not achieve complete remission after 2 courses (24 weeks) of progesterone therapy;
• No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound
• Have a desire for remaining reproductive function or uterus
• Good compliance with adjunctive treatment and follow-up

You may not qualify if:

• Hypersensitivity or contradiction for using MPA or atorvastatin
• Pregnancy or potential pregnancy
• Confirmed diagnosis of any cancer in reproductive system
• Already diagnosed with hyperlipidemia and using lipid-lowering drugs
• Acute liver disease or liver tumor (benign or malignant) or renal dysfunction
• Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
• With other factors of reproductive dysfunction;
• Strong request for uterine removal or other conservative treatment
• Smoker (\>15 cigarettes a day)
• Drinker (\>20 grams a day)

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Wang Jianliu

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Endometrial Hyperplasia; Endometrial Neoplasms

Interventions

Medroxyprogesterone Acetate; Atorvastatin

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Central Study Contacts

WANG JIANLIU, PhD/MD

CONTACT

+861088324383; wangjianliu1203@163.com

HE YIJIAO, PhD

CONTACT

+8618301512017; heyijiao2017@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Doctoral supervisor, Chief physician, Vice President

Model Details: Participants are assigned to one of two groups in parallel for the duration of the study: Control group and Experimental group;

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 9, 2023
• Study Start: January 6, 2023
• Primary Completion: August 31, 2025
• Study Completion: October 31, 2025
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)