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NCT02825719

Ulipristal Use in Chinese Population

Terminated Phase 4 Last updated 9 April 2020
What this trial tests

Phase 4 trial testing Ulipristal acetate in Fibroid in 31 participants. Terminated before completion.

Timeline
2 December 2015
Primary endpoint
31 March 2020
31 March 2020

Quick facts

Lead sponsorQueen Mary Hospital, Hong Kong
PhasePhase 4
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment31
Start date2 December 2015
Primary completion31 March 2020
Estimated completion31 March 2020
Sites1 location across Hong Kong

Drugs / interventions tested

Conditions studied

Sponsor

Queen Mary Hospital, Hong Kong

Who can join

18 and older, female only, with Fibroid. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Uterine leiomyomas is the commonest benign tumour of the female genital tract. It lead to menorrhagia, anaemia, pain and pressure symptoms. Due to the enlarged uterus, the use of minimal invasive surgery is limited. There is also increase risk of intraoperative blood transfusion. Ulipristal acetate (UPA) is a selective progesterone-receptor modulator (SPRM). Preoperative use of Ulipristal for 12 weeks has been shown to decrease uterine bleeding, fibroid volume, pre-operative anaemia and symptoms severity. However there is still lacking evidence in terms of long term safety and efficacy, especially in Chinese population. The aim of the present study is to evaluate the effect and safety on preoperative use of Ulipristal on fibroid.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Selective Progesterone Receptor Modulators-Mechanisms and Therapeutic Utility.
    Islam MS, Afrin S, Jones SI, Segars J. · · 2020 · cited 97× · PMID 32365199 · DOI 10.1210/endrev/bnaa012
  2. Progesterone Signaling and Uterine Fibroid Pathogenesis; Molecular Mechanisms and Potential Therapeutics.
    Ali M, Ciebiera M, Vafaei S, Alkhrait S, et al · · 2023 · cited 30× · PMID 37190026 · DOI 10.3390/cells12081117

Verify or expand the search:

Other trials of Ulipristal acetate

Trials testing the same drug.

Other recruiting trials for Fibroid

Currently open trials in the same condition.

Other Queen Mary Hospital, Hong Kong trials

Trials by the same sponsor.

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