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MPA Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia

Primary Purpose

Endometrial Hyperplasia Without Atypia

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Medroxyprogesterone Acetate
Dydrogesterone 10 MG
Sponsored by
Xiaojun Chen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Hyperplasia Without Atypia

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pathologically confirmed diagnosis of endometrial hyperplasia without atypia;
  • Consent informed and signed;
  • Able to follow treatment and take therapy in Obstetrics and Gynecology of Fudan University

Exclusion Criteria:

  • Liver disease or liver tumor (benign or malignant)
  • Kidney disease or kidney tumor (benign or malignant)
  • Other malignancies in reproductive organs
  • Breast cancer or other progesterone-dependent tumors
  • History of endometrial atypical hyperplasia or endometrial cancer
  • Any contradictions against progesterone
  • Under treatment of progestin therapy or oral conceptive drugs one month before enrollment.
  • Pregnancy or suspicion of pregnancy
  • Ask for other treatment

Sites / Locations

  • Obstetrics and Gynecology Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Medroxyprogesterone Acetate

dydrogesterone

Arm Description

EH patients will take MPA (Medroxyprogesterone Acetate) 10mg daily from tenth day of menstruation for 15 days for 3months. Endometrial Biopsy (Pipelle) will be performed every 3 months to examine the endometrium. All of the findings will be recorded.

EH patients will take dydrogesterone 10 mg, 2 tablets twice daily from tenth day of menstruation for 15 days for 3-6 months. Endometrial Biopsy (Pipelle) will be performed every 3-month to examine the endometrium. All of the findings will be recorded.

Outcomes

Primary Outcome Measures

Pathological complete response (CR) rates
The CR rates will be calculated after 3 and 6-month therapy based on the following formula: (Number of participants who got CR)/(All enrolled participants). The CR rates will be compared between two therapies (MPA VS dydrogesterone), also between two lesions (SH VS CH).

Secondary Outcome Measures

Median time of pathological complete response (CR)
Median time of histologic regression from endometrial hyperplasia without atypia to normal endometrium, and comparison will be performed between two treatments and two lesions (SH vs CH).
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Adverse events related with MPA (Medroxyprogesterone acetate ) or dydrogesterone include acne, irregular bleeding, breast tenderness, decreased scalp hair, difficulty falling or remaining asleep, stomach pain, and weight loss or gain, depression and mood changes. Severe side effects include thrombus and impaired liver and kidney function. The investigators will record any symptoms, evaluate the correlation and count the events. And comparison will be performed between two treatments and two lesions (SH vs CH).
Relapse rates
All enrolled patients will be followed up for 2 years. During the following-up period, if patients recur after complete regression, they will be counted and the number of recurrence will be divided by number of patients followed up, then we can get the relapse rates.Comparison will be performed between two treatments and two lesions (SH vs CH).
Rate of pregnancy
For patients have a desire for fertility, pregnancies, births and related outcomes will be counted, and the rate of pregnancy will be counted as number of pregnancies/ number of patients trying to fertility in the following period. Comparison will be performed between two treatments and two lesions (SH vs CH).
Compliance
The investigators designed a questionnaire to evaluate the compliance through treatment. Comparison will be performed between two treatments and two lesions (SH vs CH).
cost
Treatment-related cost in each patient during the period beginning from randomization to the date of CR.Comparison will be performed between two treatments and two lesions (SH vs CH).

Full Information

First Posted
September 10, 2018
Last Updated
February 15, 2023
Sponsor
Xiaojun Chen
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1. Study Identification

Unique Protocol Identification Number
NCT03675139
Brief Title
MPA Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia
Official Title
Medroxyprogesterone Acetate (MPA) Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
May 14, 2022 (Actual)
Study Completion Date
May 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaojun Chen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To compare the efficacy of Medroxyprogesterone Acetate with dydrogesterone in patients having endometrial hyperplasia (EH) without atypia.
Detailed Description
Patients pathologically diagnosed with nonatypical simple or complex EH will be enrolled. Exclusion criteria include malignancy, liver disease or liver tumor (benign or malignant), kidney disease or kidney tumor (benign or malignant), any contradictions against progesterone, history of endometrial atypical hyperplasia or endometrial cancer, any progesterone-dependent tumors, ask for other treatment. A detailed history including menstruation, fertility, other diseases and family history will be collected. Basic information including age, waist circumstances, hip circumstances and blood pressure will also be collected. Blood tests including fasting blood glucose (FBG), postprandial blood glucose (PBG), fasting insulin (FINS), SHBG, sex hormone levels, blood lipids, liver and kidney functions will be performed before taking progesterone orally. All enrolled and consent informed patients will be randomized into two groups, A and B, using computer-generated random numbers. Patients in group A will orally take MPA (Medroxyprogesterone Acetate) (angonghuangtitong, Xianju pharmaceuticals, China)10mg daily from tenth day of menstruation for 15 days for 3-6months. While patients in group B will take dydrogesterone (duphaston; Abbott Healthcare Products B.V, the Netherlands) 10 mg, 2 tablets twice daily from fifth day of menstruation for 20 days for 3-6 months. Endometrial Biopsy (Pipelle) will be performed every 3 months to examine the endometrium. Complete response (CR) is defined as the reversion of EH to proliferative or secretory endometrium; partial response (PR) is defined as regression to disordered proliferative endometrium (DPE) or simple hyperplasia without atypic (only for complex hyperplasia); no response (NR) is defined as the persistence of the disease; and progressive disease (PD) is defined as the progression of endometrial lesions. Another 3-month therapy will be continued if the patients get NR. The longest treatment periods will be 6 months. If the patient gets PD or NR after 6 months therapy, new options must be put. At least 3-month maintenance therapy will be recommended for patients get CR. And all of the enrolled patients will be followed up for 2 years. All data of the therapy, reverse events, side effects, pregnancy and long-term outcomes will be collected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Hyperplasia Without Atypia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
471 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medroxyprogesterone Acetate
Arm Type
Experimental
Arm Description
EH patients will take MPA (Medroxyprogesterone Acetate) 10mg daily from tenth day of menstruation for 15 days for 3months. Endometrial Biopsy (Pipelle) will be performed every 3 months to examine the endometrium. All of the findings will be recorded.
Arm Title
dydrogesterone
Arm Type
Experimental
Arm Description
EH patients will take dydrogesterone 10 mg, 2 tablets twice daily from tenth day of menstruation for 15 days for 3-6 months. Endometrial Biopsy (Pipelle) will be performed every 3-month to examine the endometrium. All of the findings will be recorded.
Intervention Type
Drug
Intervention Name(s)
Medroxyprogesterone Acetate
Other Intervention Name(s)
Provera
Intervention Description
At a dosage of 10mg/day
Intervention Type
Drug
Intervention Name(s)
Dydrogesterone 10 MG
Other Intervention Name(s)
Duphaston
Intervention Description
At a dosage of 20 mg/day
Primary Outcome Measure Information:
Title
Pathological complete response (CR) rates
Description
The CR rates will be calculated after 3 and 6-month therapy based on the following formula: (Number of participants who got CR)/(All enrolled participants). The CR rates will be compared between two therapies (MPA VS dydrogesterone), also between two lesions (SH VS CH).
Time Frame
From date of randomization until the date of CR, assessed up to 6 months
Secondary Outcome Measure Information:
Title
Median time of pathological complete response (CR)
Description
Median time of histologic regression from endometrial hyperplasia without atypia to normal endometrium, and comparison will be performed between two treatments and two lesions (SH vs CH).
Time Frame
From date of randomization until the date of CR, assessed up to 6 months
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Adverse events related with MPA (Medroxyprogesterone acetate ) or dydrogesterone include acne, irregular bleeding, breast tenderness, decreased scalp hair, difficulty falling or remaining asleep, stomach pain, and weight loss or gain, depression and mood changes. Severe side effects include thrombus and impaired liver and kidney function. The investigators will record any symptoms, evaluate the correlation and count the events. And comparison will be performed between two treatments and two lesions (SH vs CH).
Time Frame
up to 2 years after the treatment for each patient
Title
Relapse rates
Description
All enrolled patients will be followed up for 2 years. During the following-up period, if patients recur after complete regression, they will be counted and the number of recurrence will be divided by number of patients followed up, then we can get the relapse rates.Comparison will be performed between two treatments and two lesions (SH vs CH).
Time Frame
up to 2 years after the treatment for each patient
Title
Rate of pregnancy
Description
For patients have a desire for fertility, pregnancies, births and related outcomes will be counted, and the rate of pregnancy will be counted as number of pregnancies/ number of patients trying to fertility in the following period. Comparison will be performed between two treatments and two lesions (SH vs CH).
Time Frame
up to 2 years after the treatment for each patient
Title
Compliance
Description
The investigators designed a questionnaire to evaluate the compliance through treatment. Comparison will be performed between two treatments and two lesions (SH vs CH).
Time Frame
up to 2 years after the treatment for each patient
Title
cost
Description
Treatment-related cost in each patient during the period beginning from randomization to the date of CR.Comparison will be performed between two treatments and two lesions (SH vs CH).
Time Frame
From date of randomization until the date of CR, assessed up to 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically confirmed diagnosis of endometrial hyperplasia without atypia; Consent informed and signed; Able to follow treatment and take therapy in Obstetrics and Gynecology of Fudan University Exclusion Criteria: Liver disease or liver tumor (benign or malignant) Kidney disease or kidney tumor (benign or malignant) Other malignancies in reproductive organs Breast cancer or other progesterone-dependent tumors History of endometrial atypical hyperplasia or endometrial cancer Any contradictions against progesterone Under treatment of progestin therapy or oral conceptive drugs one month before enrollment. Pregnancy or suspicion of pregnancy Ask for other treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojun Chen, PhD
Organizational Affiliation
Obstetrics & Gynecology Hospital of Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Obstetrics and Gynecology Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China

12. IPD Sharing Statement

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MPA Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia

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