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

NCT03520439 | Completed Phase 2

• 1 other identifier: MF2018
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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:

1. 1.Mifepristone tablets of 10mg, 1 tablet daily, oral
2. 2.Placebo, 1 tablet daily, oral

Conditions

Adenomyosis

Keywords

Adenomyosis; mifepristone; the selective progesterone receptor modulators; treatment

Outcome Measures

Primary Outcomes (1)

• 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 )

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

Secondary Outcomes (3)

• changes in uterine bleeding

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

• improvement of anemia

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

• Size of uterus

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

Study Arms (2)

study group

EXPERIMENTAL

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

Drug: Mifepristone

control group

PLACEBO COMPARATOR

placebo，10mg，One tablet daily, oral treatment

Drug: Placebo

Interventions

Mifepristone DRUG

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

Also known as: RU486

study group

Placebo DRUG

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

control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Women's Hospital of Zhejiang Medical University

Hangzhou, Zhejiang, China

Location

Related Publications (1)

• Che X, Wang J, Sun W, He J, Wang Q, Zhu D, Zhu W, Zhang J, Dong J, Xu J, Zheng F, Zhou J, Zhao W, Lin Q, Ye L, Zhao X, Xu Z, Chen Y, Wang J, Wu W, Zhai L, Zhou Y, Zheng J, Zhang X. Effect of Mifepristone vs Placebo for Treatment of Adenomyosis With Pain Symptoms: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2317860. doi: 10.1001/jamanetworkopen.2023.17860.

  PMID: 37307001 DERIVED

MeSH Terms

Conditions

Adenomyosis

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 9, 2018
• Study Start: May 19, 2018
• Primary Completion: July 31, 2019
• Study Completion: October 1, 2019
• Last Updated: October 3, 2019

Record last verified: 2019-10

Locations

CN (1)