Long-term Use of Mifepristone in the Treatment of Adenomyosis

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.

Conditions

• Adenomyosis
• Mifepristone

Interventions

DRUG

mifepristone

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

Sponsors & Collaborators

• Ningbo Women & Children's Hospital

  collaborator OTHER

• Jiaxing Maternity and Child Health Care Hospital

  collaborator OTHER

• The Affiliated Hospital of Medical School, Ningbo University

  collaborator UNKNOWN

• Qilu Hospital of Shandong University

  collaborator OTHER

• Obstetrics & Gynecology Hospital of Fudan University

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Anhui Provincial Hospital

  collaborator OTHER_GOV

• Women's Hospital School Of Medicine Zhejiang University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-01

Primary Completion

2023-12-31

Completion

2023-12-31

Countries

• China

Study Locations