Long-term Use of Mifepristone in the Treatment of Adenomyosis

NCT05151016 | Unknown Early Phase 1

• 1 other identifier: 20210229
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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. 1.Study Group: mifepristone tablets, 10 mg, 1 tablet daily, taken orally (beginning on the third day of Menstruation) for 24 weeks;
2. 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.

Conditions

Adenomyosis; Mifepristone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pictorial blood loss assessment chart（PBAC）

  Baseline and week 24

• Change from baseline in uterine size at week 24

  Baseline and week 24

• Change from baseline in hemoglobin at week 24

  Baseline and week 24

• Change from baseline in CA125 at week 24

  Baseline and week 24

Study Arms (2)

mifepristone

EXPERIMENTAL

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

Drug: mifepristone

Triptorelin Acetate

ACTIVE COMPARATOR

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

Interventions

mifepristone DRUG

Mifepristone tablets, 10mg, 1 tablet daily, taken orally (beginning on the third day of Menstruation) for 24 weeks

mifepristone

Triptorelin Acetate DRUG

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

Triptorelin Acetate

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Women's Hospital of Zhejiang Medical University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Adenomyosis

Interventions

Mifepristone; Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Central Study Contacts

Xinmei Zhang, M.D.

CONTACT

(+86)18957110072; zxm20130729@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: December 9, 2021
• Study Start: December 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 9, 2021

Record last verified: 2021-11

Locations

CN (1)