Ulipristal Use in Chinese Population

April 7, 2020 updated by: Lui Man Wa, Queen Mary Hospital, Hong Kong

Pilot Study on the Pre-operative Use of Ulipristal on Fibroid in Chinese Population

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.

Study Overview

Detailed Description

Uterine leiomyomas is the commonest benign tumour of the female genital tract. It is often asymptomatic, but can also lead to anaemia, pain and pressure symptoms. It is the commonest indication for hysterectomy, especially abdominal hysterectomy. Currently, the use of hormonal treatment is associated with side effects including gastrointestinal upset, bloating, weight gain and thromboembolic risks. The main stay for treatment relies on surgery.

Furthermore, the use of minimal invasive surgeries is limited by the size of the fibroids. Preoperative use of Gonadotrophic Releasing Hormone analogues (GnRHa) is effective in shrinkage of the uterine leiomyomas and reduction of uterine bleeding. However, postmenopausal symptoms including hot flushes, vaginal dryness are profound.

Ulipristal acetate (UPA), previously named CDB-2914, is a selective progesterone-receptor modulator (SPRM). It binds to the progesterone receptors with high affinity. It inhibits follicular development and ovulation, while it has no significant effects on estradiol levels and antiglucocorticoid activity. Preoperative use of Ulipristal for symptomatic uterine fibroids has been investigated in randomized controlled study with improvement in terms of uterine bleeding, fibroids volume, pre-operative anaemia and symptoms severity. However there is still lacking evidence in terms of long term safety and efficacy. Also there is lack of evidence in Chinese population.

The aim of the present study is to evaluate the effect and safety on preoperative use of Ulipristal on fibroid.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hong Kong, Hong Kong
        • Department of Obstetrics and Gynaecology, Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Scheduled for hysterectomy for symptomatic fibroid
  • Be a Chinese
  • Pre-menopausal
  • With a Pictorial bleeding assessment chart score > 100 during menstruation at the preceding month
  • Non-pregnant
  • With a body-mass index between 18 to 30.

Exclusion Criteria:

  • History of uterine surgery (apart from Caesarean section or cervical conization), endometrial ablation or uterine artery embolization
  • History of gynaecological malignancies
  • History of endometrial hyperplasia
  • Known haemoglobinopathy (e.g. thalassaemia)
  • Known severe coagulation disorder
  • Has one or more ovarian cysts >= 4 cm in diameter diagnosed by ultrasound
  • History of use of Selective Progesterone Receptor Modulator (SPRM)
  • Current (within 12 months) problem with alcohol or drug abuse.
  • Known allergy to SPRM or ferrous sulphate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ulipristal
Patients will be prescribed Ulipristal acetate 5mg daily for 12 weeks before operation. If the patients have anaemia with haemoglobin less than 10g/dL, ferrous sulphate 300mg three times a day will be prescribed as well. Tranexamic Acid 500mg four times a day will be prescribed on request basis.
Ulipristal acetate 5mg daily will be prescribed
Other Names:
  • Esyma
Ferrous sulphate 300mg three times a day will be prescribed if haemoglobin level is less than 10g/dL.
Other Names:
  • Ferasul
Tranexamic Acid 500mg four times a day on request basis will be prescribed if patient complained of menorrhagia.
Other Names:
  • Transamin
Placebo Comparator: Placebo
Patients will be prescribed placebo pills daily for 12 weeks before operation. If the patients have anaemia with haemoglobin less than 10g/dL, ferrous sulphate 300mg three times a day will be prescribed as well. Tranexamic Acid 500mg four times a day will be prescribed on request basis.
Ferrous sulphate 300mg three times a day will be prescribed if haemoglobin level is less than 10g/dL.
Other Names:
  • Ferasul
Tranexamic Acid 500mg four times a day on request basis will be prescribed if patient complained of menorrhagia.
Other Names:
  • Transamin
Placebo pills will be prescribed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of uterine bleeding
Time Frame: Through study completion, an average of 14weeks
Pictorial bleeding assessment chart will be used for assessment of uterine bleeding. Patients will be assessed before the start of treatment, after completion of 6 weeks course and after completion of 12 weeks course. The change of uterine bleeding after completion of 12 weeks course of treatment will be recorded.
Through study completion, an average of 14weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of haemoglobin level
Time Frame: Through study completion, an average of 14weeks
The change of haemoglobin level after completion of 12 weeks course will be recorded.
Through study completion, an average of 14weeks
Change of fibroid volume
Time Frame: Through study completion, an average of 14weeks
The fibroid volume will be measured using ultrasonography before start of treatment, after 6 weeks course of treatment and after completion of 12 weeks course of treatment.
Through study completion, an average of 14weeks
Intraoperative blood loss
Time Frame: After completion of 12 weeks course, the intraoperative blood loss at the time of performance of hysterectomy will be assessed.
The amount of blood loss at hysterectomy will be recorded.
After completion of 12 weeks course, the intraoperative blood loss at the time of performance of hysterectomy will be assessed.
Conversion to less invasive intervention options
Time Frame: After completion of 12 weeks course of treatment and before the scheduled operation
2 weeks before scheduled operation, patients will be assessed by the operation team and the most suitable route of hysterectomy will be discussed again. The possibility of conversion to less invasive intervention options including from laparotomy to laparoscopy will be recorded.
After completion of 12 weeks course of treatment and before the scheduled operation
Side effects
Time Frame: Through study completion, an average of 14weeks
The side effects including nausea, vomiting, headache, dyspepsia will be recorded.
Through study completion, an average of 14weeks
Histology of the operative specimen
Time Frame: After completion of 12 weeks course of treatment
Presence of malignancy or hyperplasia in the operative specimen will be recorded.
After completion of 12 weeks course of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Ernest H. Y. Ng, The University of Hong Kong, HONG KONG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2015

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

May 29, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (Estimate)

July 7, 2016

Study Record Updates

Last Update Posted (Actual)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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