Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03520439
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : June 13, 2018
Sponsor:
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
Information provided by (Responsible Party):
xinmei zhang, Women's Hospital School Of Medicine Zhejiang University

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

Condition or disease Intervention/treatment Phase
Adenomyosis Drug: Mifepristone Drug: Placebo Phase 2 Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
Official Title: Mifepristone Versus Placebo to Treat Adenomyosis: a Double-blind, Multicentre,Randomized Clinical Trial
Actual Study Start Date : May 19, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: study group
mifepristone tablets ,10mg,One tablet daily, oral treatment
Drug: Mifepristone
Oral mifepristone 10mg (first menstrual third days), 1 times a day, 12 weeks, fasting or taking 2 hours after eating
Other Name: RU486

Placebo Comparator: control group
placebo,10mg,One tablet daily, oral treatment
Drug: Placebo
Oral Placebo Oral Tablet 1# (first menstrual third days), 1 times a day, 12 weeks, fasting or taking 2 hours after eating




Primary Outcome Measures :
  1. changes in chronic pelvic pain associated with adenomyosis [ Time Frame: Baseline ,taking medicine for 1-month, 2-month, 3-month and post treatment 1- month(approximately 16 weeks) ]
    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 :
  1. changes in uterine bleeding [ Time Frame: Baseline ,taking medicine for 1-month, 2-month, 3-month and post treatment 1- month(approximately 16 weeks) ]
    To evaluate the pictorial blood loss assessment chart (PBAC) changes

  2. improvement of anemia [ Time Frame: Baseline ,taking medicine for 1-month, 3-month (approximately 16 weeks) ]
    To evaluate the hemoglobin changes,

  3. Size of uterus [ Time Frame: Baseline ,taking medicine for 1-month, 3-month (approximately 16 weeks) ]
    To evaluate the uterine volume changes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

No menopause

Exclusion Criteria:

  1. HB<90G/L
  2. Undiagnosed abnormal vaginal bleeding or endometrial lesions;
  3. Pregnancy and lactation women and those who are preparing to give birth when taking the medication or within 6 months of stopping the medication;
  4. Malignant tumors (including the reproductive system and other systems);
  5. The patients with severe heart, liver, kidney disease and adrenocortical insufficiency;
  6. The results of follow-up laboratory test indicate abnormal clinical significance;
  7. 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;
  8. Suffering from any disease or condition that may cause the study drug to alter absorption, accumulate excessively, affect metabolism, or change the excretion pattern;
  9. Having clinically significant depression within the current or most recent year;
  10. People who regularly take analgesics due to other underlying diseases;
  11. 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;
  12. 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;
  13. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520439


Contacts
Layout table for location contacts
Contact: Xinmei Zhang, M.D. (+86)18957110072 zxm20130729@163.com

Locations
Layout table for location information
China, Zhejiang
Women's Hospital of Zhejiang Medical University Recruiting
Hangzhou, Zhejiang, China
Contact: Xinmei H Zhang    8618957110072 ext 8618957110072    zxm20130729@163.com   
Sponsors and Collaborators
xinmei zhang
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

Layout table for additonal information
Responsible Party: xinmei zhang, Director, Women's Hospital School Of Medicine Zhejiang University
ClinicalTrials.gov Identifier: NCT03520439     History of Changes
Other Study ID Numbers: MF2018
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: May 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by xinmei zhang, Women's Hospital School Of Medicine Zhejiang University:
Adenomyosis
mifepristone
the selective progesterone receptor modulators
treatment

Additional relevant MeSH terms:
Layout table for MeSH terms
Adenomyosis
Uterine Diseases
Genital Diseases, Female
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents