Long-term Use of Mifepristone in the Treatment of Adenomyosis (LUOMITTOA)

Women's Hospital School Of Medicine Zhejiang University

Status and phase: Unknown; Early Phase 1

Conditions: Adenomyosis; Mifepristone

Treatments: Drug: Triptorelin Acetate; Drug: mifepristone

Study type: Interventional

Funder types: Other

Identifiers

NCT05151016

20210229

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

mifepristone

Experimental group

Description:

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

Treatment:

Drug: mifepristone

Triptorelin Acetate

Active Comparator group

Description:

dafinil, 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks.

Treatment:

Drug: Triptorelin Acetate