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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Adenomyosis; Mifepristone
• Intervention / Treatment: Drug: mifepristone; Drug: Triptorelin Acetate

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Xinmei Zhang, M.D.; Phone Number: (+86)18957110072; Email: zxm20130729@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Women's Hospital of Zhejiang Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: mifepristone; mifepristone tablets，10mg，One tablet daily, oral treatment	Drug: mifepristone; Mifepristone tablets, 10mg, 1 tablet daily, taken orally (beginning on the third day of Menstruation) for 24 weeks
ACTIVE_COMPARATOR: Triptorelin Acetate; dafinil, 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks.	Drug: Triptorelin Acetate; dafinil, 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Pain on the Visual Analogue Scale (VAS) at week 24	The VAS is the most commonly used instrument assessing pain in clinical practice. It reflects the patient's subjective perception of pain. Possible scores range from 0 (no pain) to 10 (worst possible pain). The last observation carry forward was used for missing data. Change=(Week 24 Score - Baseline Score)	Baseline and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pictorial blood loss assessment chart（PBAC）	Recording the use of tampons and sanitary towels by placing a tally mark under the day next to the box. Record clots by indicating whether they are the size of a 1p or 50pcoin in the clots/ flooding row under the relevant day. E.g. under day1 you may say 50p*1 and 1p*3. Record any incidences of flooding by placing a tally mark in the clots/ flooding row under the relevant day. A lightly stained towel (pic 1) will score 1 point, a moderately stained towel (pic 2) 5 points, a towel which is saturated with blood(pic 3) will score 20 points. A lightly stained tampon (pic 4) will score 1 point, a moderately stained tampon (pic 5) 5 points and a tampon that is fully saturated will score 10 points. A clot the size of 1p scores 1 point, a 50p sized clot scores 5 pointsand flooding also scores 5 points. Finally, total up the scores. A score of100 or greater may indicate a heavy period. Change=Week 24 Score - Baseline Score	Baseline and week 24
Change from baseline in uterine size at week 24	Uterine size usually reflects the size of the adenomyosis lesion, and is measured in cubic centimeters. Change=(Week 24 Uterine Size - Baseline Uterine Size)*0.5236	Baseline and week 24
Change from baseline in hemoglobin at week 24	Hemoglobin, measured in grams per liter, reflects a patient's level of menstrual blood loss. Change=(Week 24 Hemoglobin Content - Baseline Hemoglobin Content)	Baseline and week 24
Change from baseline in CA125 at week 24	CA125 is measured in micrograms per liter. Change=(Week 24 Hemoglobin Content - Baseline Hemoglobin Content)	Baseline and week 24

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Qilu Hospital of Shandong University; Obstetrics & Gynecology Hospital of Fudan University; Jiaxing Maternity and Child Health Care Hospital; Anhui Provincial Hospital; Ningbo Women & Children's Hospital; The Affiliated Hospital of Medical School, Ningbo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (ACTUAL): December 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 9, 2021
• Last Update Submitted That Met QC Criteria: November 26, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases; Adenomyosis; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Abortifacient Agents; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Triptorelin Pamoate; Mifepristone
• Other Study ID Numbers: 20210229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No