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NCT05151016: LUOMITTOA

Long-term Use of Mifepristone in the Treatment of Adenomyosis

Status unknown EARLY_PHASE1 Last updated 9 December 2021
What this trial tests

EARLY_PHASE1 trial testing mifepristone in Adenomyosis in 140 participants. Status unknown.

Timeline
1 December 2021
Primary endpoint
31 December 2023
31 December 2023

Quick facts

Lead sponsorWomen's Hospital School Of Medicine Zhejiang University
PhaseEARLY_PHASE1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment140
Start date1 December 2021
Primary completion31 December 2023
Estimated completion31 December 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Women's Hospital School Of Medicine Zhejiang University

Who can join

Adults 18 to 50, female only, with Adenomyosis or Mifepristone. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Current Medical Therapy for Adenomyosis: From Bench to Bedside.
    Etrusco A, Barra F, Chiantera V, Ferrero S, et al · · 2023 · cited 53× · PMID 37837497 · DOI 10.1007/s40265-023-01957-7

Verify or expand the search:

Other trials of mifepristone

Trials testing the same drug.

Other recruiting trials for Adenomyosis

Currently open trials in the same condition.

Other Women's Hospital School Of Medicine Zhejiang University trials

Trials by the same sponsor.

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