Clinical trial NCT05151016: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Adenomyosis
Mifepristone
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
Collaborators: name: Ningbo Women & Children's Hospital
name: Jiaxing Maternity and Child Health Care Hospital
name: The Affiliated Hospital of Medical School, Ningbo University
name: Qilu Hospital of Shandong University
name: Obstetrics & Gynecology Hospital of Fudan University
name: The First Affiliated Hospital with Nanjing Medical University
name: Anhui Provincial Hospital
First posted: 2021-12-09
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from Baseline in Pain on the Visual Analogue Scale (VAS) at week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Pictorial blood loss assessment chart（PBAC）
timeFrame: Baseline and week 24
measure: Change from baseline in uterine size at week 24
timeFrame: Baseline and week 24
measure: Change from baseline in hemoglobin at week 24
timeFrame: Baseline and week 24
measure: Change from baseline in CA125 at week 24
timeFrame: Baseline and week 24
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's Hospital of Zhejiang Medical University
state: Zhejiang
Study officials:
References: