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Ulipristal Use in Chinese Population

NCT02825719 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-04-09

No results posted yet for this study

Summary

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.

Conditions

  • Fibroid

Interventions

DRUG

Ulipristal acetate

Ulipristal acetate 5mg daily will be prescribed

OTHER

Placebo pills

Placebo pills will be prescribed

DRUG

Ferrous sulphate

Ferrous sulphate 300mg three times a day will be prescribed if haemoglobin level is less than 10g/dL.

DRUG

Tranexamic Acid

Tranexamic Acid 500mg four times a day on request basis will be prescribed if patient complained of menorrhagia.

Sponsors & Collaborators

  • Queen Mary Hospital, Hong Kong

    lead OTHER

Principal Investigators

  • Ernest H. Y. Ng · The University of Hong Kong, HONG KONG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-02
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02825719 on ClinicalTrials.gov