Long-term Use of Mifepristone in the Treatment of Adenomyosis

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Brief Title

Long-term Use of Mifepristone in the Treatment of Adenomyosis

Official Title

A Multicenter Randomized Clinical Trial of Mifepristone Versus GnRHa for the Treatment of Adenomyosis

Brief Summary

      The design was a prospective, randomized, positive-control, parallel-group, multicenter
      clinical trial. The study included a randomized, parallel-group treatment for 24 weeks in 140
      subjects from eight hospitals in seven cities across the country who were diagnosed with
      Adenomyosis and associated symptoms (dysmenorrhea, with or without heavy menstrual flow) ,
      the subjects were randomly assigned to the following two groups:

        1. Study Group: mifepristone tablets, 10 mg, 1 tablet daily, taken orally (beginning on the
           third day of Menstruation) for 24 weeks;

        2. Control Group: dafinil (Triptorelin Acetate) , 3.75 mg, first injection on the third day
           of menstruation, followed by intramuscular injection every 28 days for 24 weeks.
    


Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Change from Baseline in Pain on the Visual Analogue Scale (VAS) at week 24

Secondary Outcome

 Pictorial blood loss assessment chart(PBAC)

Condition

Adenomyosis

Intervention

mifepristone

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

140

Start Date

December 1, 2021

Completion Date

December 31, 2023

Primary Completion Date

December 31, 2023

Eligibility Criteria

        Inclusion criteria.

          -  Female, over 18 years old and not menopausal, agree to tripriline acetate and
             mifepristone treatment and informed consent

          -  Patients were diagnosed as adenomyosis by postoperative pathology, or those who did
             not undergo surgery but were diagnosed by auxiliary examination, such as
             ultrasonography and MRI.

          -  Dysmenorrhea with or Without Menorrhagia

          -  Requiring preservation of the uterus or fertility

          -  No other hormonal treatment for Adenomyosis was received in the three months prior to
             treatment

          -  Normal or non-clinically significant cervical cytology results (6 months before the
             screening period)

        Exclusion criteria.

          -  Pelvic pain and vaginal bleeding of unknown or non-Adenomyosis causes

          -  Benign Lesions such as endometrial polyp, submucous Myoma or suspicious malignant
             tumors were diagnosed by ultrasonography

          -  Receiving other hormone drugs for Adenomyosis

          -  Use other drugs that interact with tripriline acetate and mifepristone, and can not be
             stopped

          -  Patients with severe heart, liver, kidney disease and Adrenal insufficiency; drug
             allergy or allergic constitution

          -  Participated in other clinical trials within 3 months, and other factors considered
             unsuitable for the trial

          -  Pregnant, lactating women and those who prepare for childbirth during the treatment or
             within six months after treatment

          -  Postmenopausal women.
      

Gender

Female

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

, (+86)18957110072, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05151016

Organization ID

20210229


Responsible Party

Sponsor

Study Sponsor

Women's Hospital School Of Medicine Zhejiang University

Collaborators

 Ningbo Women & Children's Hospital

Study Sponsor

, , 


Verification Date

November 2021