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Evaluation of Therapeutic Effect and Safety of Mifepristone in the Treatment of Adenomyosis (ETESRTA)

Primary Purpose

Adenomyosis

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Mifepristone

Placebo

About this trial

This is an interventional treatment trial for Adenomyosis focused on measuring Adenomyosis, mifepristone, the selective progesterone receptor modulators, treatment

Eligibility Criteria

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

Inclusion Criteria:

B-ultrasound or magnetic resonance imaging (MRI) examination confirmed that the subject has adenomyosis, and the uterus is less than 10 weeks of pregnancy;
Visual analogue scale (VAS) of adenomyosis-associated pain> 0 points; with or without menorrhagia (PBAC≥100 points);
Women between 18 and 50 years old who currently have no childbearing requirements;
Normal or cervical cytology results without clinical significance (results within 6 months before the screening period);
Willing to choose a barrier method of contraception if contraception is needed;
Be tested voluntarily and sign the informed consent.
No menopause

No menopause

Exclusion Criteria:

HB<90G/L
Undiagnosed abnormal vaginal bleeding or endometrial lesions;
Pregnancy and lactation women and those who are preparing to give birth when taking the medication or within 6 months of stopping the medication;
Malignant tumors (including the reproductive system and other systems);
The patients with severe heart, liver, kidney disease and adrenocortical insufficiency;
The results of follow-up laboratory test indicate abnormal clinical significance;
The allergic persons or those who have been allergic to multiple drugs, or are allergic to active ingredients or any excipients of the study drug;
Suffering from any disease or condition that may cause the study drug to alter absorption, accumulate excessively, affect metabolism, or change the excretion pattern;
Having clinically significant depression within the current or most recent year;
People who regularly take analgesics due to other underlying diseases;
Ketoconazole, itraconazole, erythromycin, rifampicin, corticosteroids (hydrocortisone, prednisone, dexamethasone, etc.), and some anticonvulsants (phenytoin, phenobarbital, carbamazepine, etc.), griseofulvin, non-steroidal anti-inflammatory drugs (aspirin, acetaminophen, etc.) that are being used and cannot be stopped during the study;
Previous use of hormone drugs, including: a. use of GnRH agonists within 6 months before the screening period; b. use of progestins or danazol and other long-acting hormones within 3 months before the screening period; c. use of oral contraceptive-like short-acting hormones within one month before the screening period;
Patients who participated in other clinical trials within 3 months before the screening, or who are considered inappropriate to participate in the study by other investigators.

Sites / Locations

Women's Hospital of Zhejiang Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

study group

control group

Arm Description

mifepristone tablets ，10mg，One tablet daily, oral treatment

placebo，10mg，One tablet daily, oral treatment

Outcomes

Primary Outcome Measures

changes in chronic pelvic pain associated with adenomyosis

To evaluate the visual analogue scale (VAS) changes.By using 10-cm visual analogue scales (0 = no pain, 10 = worst pain). Women will be asked to give the pain score at each follow up (i.e.Baseline ,taking medicine for 1-month, 2-month, 3-month, post treatment 1- month )

Secondary Outcome Measures

changes in uterine bleeding

To evaluate the pictorial blood loss assessment chart (PBAC) changes

improvement of anemia

To evaluate the hemoglobin changes,

Size of uterus

To evaluate the uterine volume changes

Full Information

NCT ID

NCT03520439

First Posted

April 27, 2018

Last Updated

October 1, 2019

Sponsor

xinmei zhang

Collaborators

Anhui Province Cancer Hospital, Huzhou Maternity and Child Care Hospital, Jiaxing Maternity and Child Health Care Hospital, Jinhua Municipal Central Hospital, The Central Hospital of Lishui City, The Affiliated Hospital of Medical School of Ningbo University, Ningbo Maternity and Child Care Hospital, The People's Hospital of Quzhou, Shaoxing Women and Children's Hospital, First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Sir Run Run Shaw Hospital, Taizhou First People's Hospital, Zhoushan Maternity and Infant Hospital, Shaoxing People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03520439

Brief Title

Evaluation of Therapeutic Effect and Safety of Mifepristone in the Treatment of Adenomyosis

Acronym

ETESRTA

Official Title

Mifepristone Versus Placebo to Treat Adenomyosis: a Double-blind, Multicentre，Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

May 19, 2018 (Actual)

Primary Completion Date

July 31, 2019 (Actual)

Study Completion Date

October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

xinmei zhang

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This clinical trial is designed to study the effectiveness and safety of mifepristone in the treatment of symptomatic adenomyosis with multi center, random, double blind and controlled clinical trials. This multicenter study is performed in 150 subjects who are diagnosed as adenomyosis . Twelve weeks of randomization, allocation concealment, double-blind, placebo-controlled, parallel grouping. Subjects are randomly assigned to one of two treatment groups and received one of the following treatments: Mifepristone tablets of 10mg, 1 tablet daily, oral Placebo, 1 tablet daily, oral

Detailed Description

Adenomyosis is a common benign disease of Gynecology, with secondary progressive dysmenorrhea and menorrhagia as the main clinical manifestations, which seriously harm the physical and mental health of the patients. Most patients have the desire to retain the uterus. Therefore, the treatment of drug conservative treatment is dominant in the treatment of adenomyosis. However, the current clinical treatment of adenomyosis still has some limitations and needs to be improved. Therefore, it is imperative to expand the clinical medication of adenomyosis. Mifepristone is defined as a selective progesterone receptor modulator. Under specific conditions, it plays the role of anti progestin, inhibits endometrial proliferation, inhibits ovulation, and can cause reversible amenorrhea. In recent years, it has been widely used in of uterine leiomyoma and endometriosis. Adenomyosis is also closely related to hormone related diseases, especially endometriosis. At present, the study of mifepristone in the treatment of adenomyosis is more extensive in China. A large number of domestic literature reports that low dose mifepristone for the treatment of adenomyosis is safe and effective for the treatment of adenomyosis . During the treatment of mifepristone, most of the patients had amenorrhea, obviously alleviating dysmenorrhea and reducing the menstrual volume, reducing the uterine and lesion volume of the patients with adenomyosis . However, most of the domestic literature is a small sample case control study or retrospective study. There is no randomized double blind control study. There is no clinical study on the application of mifepristone to adenomyosis in foreign countries. Therefore, the clinical evidence is inadequate, and a high quality randomized controlled trial is still needed. The purpose of this study is to demonstrate the effectiveness and safety of mifepristone (10mg) in the treatment of symptomatic adenomyosis with multi center, random, double blind and controlled clinical trials. It is a new clinical study for the old medicine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenomyosis

Keywords

Adenomyosis, mifepristone, the selective progesterone receptor modulators, treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The appearance of Mifepristone Tablets and placebo tablets is the same (size, shape and color). In different treatment groups, the packaging of research drugs is the same, so that researchers or subjects or applicants can not know the assigned treatment.

Allocation

Randomized

Enrollment

134 (Actual)

8. Arms, Groups, and Interventions

Arm Title

study group

Arm Type

Experimental

Arm Description

mifepristone tablets ，10mg，One tablet daily, oral treatment

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

placebo，10mg，One tablet daily, oral treatment

Intervention Type

Drug

Intervention Name(s)

Mifepristone

Other Intervention Name(s)

RU486

Intervention Description

Oral mifepristone 10mg (first menstrual third days), 1 times a day, 12 weeks, fasting or taking 2 hours after eating

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral Placebo Oral Tablet 1# (first menstrual third days), 1 times a day, 12 weeks, fasting or taking 2 hours after eating

Primary Outcome Measure Information:

Title

changes in chronic pelvic pain associated with adenomyosis

Description

Time Frame

Baseline ,taking medicine for 1-month, 2-month, 3-month and post treatment 1- month（approximately 16 weeks）

Secondary Outcome Measure Information:

Title

changes in uterine bleeding

Description

To evaluate the pictorial blood loss assessment chart (PBAC) changes

Time Frame

Baseline ,taking medicine for 1-month, 2-month, 3-month and post treatment 1- month（approximately 16 weeks）

Title

improvement of anemia

Description

To evaluate the hemoglobin changes,

Time Frame

Baseline ,taking medicine for 1-month, 3-month （approximately 16 weeks）

Title

Size of uterus

Description

To evaluate the uterine volume changes

Time Frame

Baseline ,taking medicine for 1-month, 3-month （approximately 16 weeks）

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: B-ultrasound or magnetic resonance imaging (MRI) examination confirmed that the subject has adenomyosis, and the uterus is less than 10 weeks of pregnancy; Visual analogue scale (VAS) of adenomyosis-associated pain> 0 points; with or without menorrhagia (PBAC≥100 points); Women between 18 and 50 years old who currently have no childbearing requirements; Normal or cervical cytology results without clinical significance (results within 6 months before the screening period); Willing to choose a barrier method of contraception if contraception is needed; Be tested voluntarily and sign the informed consent. No menopause No menopause Exclusion Criteria: HB<90G/L Undiagnosed abnormal vaginal bleeding or endometrial lesions; Pregnancy and lactation women and those who are preparing to give birth when taking the medication or within 6 months of stopping the medication; Malignant tumors (including the reproductive system and other systems); The patients with severe heart, liver, kidney disease and adrenocortical insufficiency; The results of follow-up laboratory test indicate abnormal clinical significance; The allergic persons or those who have been allergic to multiple drugs, or are allergic to active ingredients or any excipients of the study drug; Suffering from any disease or condition that may cause the study drug to alter absorption, accumulate excessively, affect metabolism, or change the excretion pattern; Having clinically significant depression within the current or most recent year; People who regularly take analgesics due to other underlying diseases; Ketoconazole, itraconazole, erythromycin, rifampicin, corticosteroids (hydrocortisone, prednisone, dexamethasone, etc.), and some anticonvulsants (phenytoin, phenobarbital, carbamazepine, etc.), griseofulvin, non-steroidal anti-inflammatory drugs (aspirin, acetaminophen, etc.) that are being used and cannot be stopped during the study; Previous use of hormone drugs, including: a. use of GnRH agonists within 6 months before the screening period; b. use of progestins or danazol and other long-acting hormones within 3 months before the screening period; c. use of oral contraceptive-like short-acting hormones within one month before the screening period; Patients who participated in other clinical trials within 3 months before the screening, or who are considered inappropriate to participate in the study by other investigators.

Facility Information:

Facility Name

Women's Hospital of Zhejiang Medical University

City

Hangzhou

State/Province

Zhejiang

Country

China

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Therapeutic Effect and Safety of Mifepristone in the Treatment of Adenomyosis

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