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

Primary Purpose

Adenomyosis, Mifepristone

Status
Not yet recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
mifepristone
Triptorelin Acetate
Sponsored by
Women's Hospital School Of Medicine Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenomyosis

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Women's Hospital of Zhejiang Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mifepristone

Triptorelin Acetate

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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
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)
Change from baseline in CA125 at week 24
CA125 is measured in micrograms per liter. Change=(Week 24 Hemoglobin Content - Baseline Hemoglobin Content)

Full Information

First Posted
October 7, 2021
Last Updated
November 26, 2021
Sponsor
Women's Hospital School Of Medicine Zhejiang University
Collaborators
Ningbo Women & Children's Hospital, Jiaxing Maternity and Child Health Care Hospital, The Affiliated Hospital of Medical School, Ningbo University, Qilu Hospital of Shandong University, Obstetrics & Gynecology Hospital of Fudan University, The First Affiliated Hospital with Nanjing Medical University, Anhui Provincial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05151016
Brief Title
Long-term Use of Mifepristone in the Treatment of Adenomyosis
Acronym
LUOMITTOA
Official Title
A Multicenter Randomized Clinical Trial of Mifepristone Versus GnRHa for the Treatment of Adenomyosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's Hospital School Of Medicine Zhejiang University
Collaborators
Ningbo Women & Children's Hospital, Jiaxing Maternity and Child Health Care Hospital, The Affiliated Hospital of Medical School, Ningbo University, Qilu Hospital of Shandong University, Obstetrics & Gynecology Hospital of Fudan University, The First Affiliated Hospital with Nanjing Medical University, Anhui Provincial Hospital

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomyosis, Mifepristone

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mifepristone
Arm Type
Experimental
Arm Description
mifepristone tablets，10mg，One tablet daily, oral treatment
Arm Title
Triptorelin Acetate
Arm Type
Active Comparator
Arm Description
dafinil, 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
mifepristone
Intervention Description
Mifepristone tablets, 10mg, 1 tablet daily, taken orally (beginning on the third day of Menstruation) for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Triptorelin Acetate
Intervention Description
dafinil, 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks.
Primary Outcome Measure Information:
Title
Change from Baseline in Pain on the Visual Analogue Scale (VAS) at week 24
Description
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)
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Pictorial blood loss assessment chart（PBAC）
Description
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
Time Frame
Baseline and week 24
Title
Change from baseline in uterine size at week 24
Description
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
Time Frame
Baseline and week 24
Title
Change from baseline in hemoglobin at week 24
Description
Hemoglobin, measured in grams per liter, reflects a patient's level of menstrual blood loss. Change=(Week 24 Hemoglobin Content - Baseline Hemoglobin Content)
Time Frame
Baseline and week 24
Title
Change from baseline in CA125 at week 24
Description
CA125 is measured in micrograms per liter. Change=(Week 24 Hemoglobin Content - Baseline Hemoglobin Content)
Time Frame
Baseline and week 24

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinmei Zhang, M.D.
Phone
(+86)18957110072
Email
zxm20130729@163.com
Facility Information:
Facility Name
Women's Hospital of Zhejiang Medical University
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Long-term Use of Mifepristone in the Treatment of Adenomyosis

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