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Ulipristal Use in Chinese Population

Primary Purpose

Fibroid

Status
Terminated
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Ulipristal acetate
Placebo pills
Ferrous sulphate
Tranexamic Acid
Sponsored by
Queen Mary Hospital, Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibroid focused on measuring Fibroid, Ulipristal, Selective progesterone receptor modulator, Chinese

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Obstetrics and Gynaecology, Queen Mary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ulipristal

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change of uterine bleeding
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.

Secondary Outcome Measures

Change of haemoglobin level
The change of haemoglobin level after completion of 12 weeks course will be recorded.
Change of fibroid volume
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.
Intraoperative blood loss
The amount of blood loss at hysterectomy will be recorded.
Conversion to less invasive intervention options
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.
Side effects
The side effects including nausea, vomiting, headache, dyspepsia will be recorded.
Histology of the operative specimen
Presence of malignancy or hyperplasia in the operative specimen will be recorded.

Full Information

First Posted
May 29, 2016
Last Updated
April 7, 2020
Sponsor
Queen Mary Hospital, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02825719
Brief Title
Ulipristal Use in Chinese Population
Official Title
Pilot Study on the Pre-operative Use of Ulipristal on Fibroid in Chinese Population
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
Ulipristal was withdrawal from the market
Study Start Date
December 2, 2015 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Mary Hospital, Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibroid
Keywords
Fibroid, Ulipristal, Selective progesterone receptor modulator, Chinese

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ulipristal
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ulipristal acetate
Other Intervention Name(s)
Esyma
Intervention Description
Ulipristal acetate 5mg daily will be prescribed
Intervention Type
Other
Intervention Name(s)
Placebo pills
Intervention Description
Placebo pills will be prescribed
Intervention Type
Drug
Intervention Name(s)
Ferrous sulphate
Other Intervention Name(s)
Ferasul
Intervention Description
Ferrous sulphate 300mg three times a day will be prescribed if haemoglobin level is less than 10g/dL.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Transamin
Intervention Description
Tranexamic Acid 500mg four times a day on request basis will be prescribed if patient complained of menorrhagia.
Primary Outcome Measure Information:
Title
Change of uterine bleeding
Description
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.
Time Frame
Through study completion, an average of 14weeks
Secondary Outcome Measure Information:
Title
Change of haemoglobin level
Description
The change of haemoglobin level after completion of 12 weeks course will be recorded.
Time Frame
Through study completion, an average of 14weeks
Title
Change of fibroid volume
Description
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.
Time Frame
Through study completion, an average of 14weeks
Title
Intraoperative blood loss
Description
The amount of blood loss at hysterectomy will be recorded.
Time Frame
After completion of 12 weeks course, the intraoperative blood loss at the time of performance of hysterectomy will be assessed.
Title
Conversion to less invasive intervention options
Description
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.
Time Frame
After completion of 12 weeks course of treatment and before the scheduled operation
Title
Side effects
Description
The side effects including nausea, vomiting, headache, dyspepsia will be recorded.
Time Frame
Through study completion, an average of 14weeks
Title
Histology of the operative specimen
Description
Presence of malignancy or hyperplasia in the operative specimen will be recorded.
Time Frame
After completion of 12 weeks course of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernest H. Y. Ng
Organizational Affiliation
The University of Hong Kong, HONG KONG
Official's Role
Study Director
Facility Information:
Facility Name
Department of Obstetrics and Gynaecology, Queen Mary Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is to protect the privacy of individual patients
Citations:
PubMed Identifier
17430732
Citation
Parker WH. Etiology, symptomatology, and diagnosis of uterine myomas. Fertil Steril. 2007 Apr;87(4):725-36. doi: 10.1016/j.fertnstert.2007.01.093.
Results Reference
background
PubMed Identifier
16738152
Citation
Jacobson GF, Shaber RE, Armstrong MA, Hung YY. Hysterectomy rates for benign indications. Obstet Gynecol. 2006 Jun;107(6):1278-83. doi: 10.1097/01.AOG.0000210640.86628.ff.
Results Reference
background
PubMed Identifier
20168105
Citation
Jacoby VL, Autry A, Jacobson G, Domush R, Nakagawa S, Jacoby A. Nationwide use of laparoscopic hysterectomy compared with abdominal and vaginal approaches. Obstet Gynecol. 2009 Nov;114(5):1041-1048. doi: 10.1097/AOG.0b013e3181b9d222.
Results Reference
background
PubMed Identifier
11405968
Citation
Lethaby A, Vollenhoven B, Sowter M. Pre-operative GnRH analogue therapy before hysterectomy or myomectomy for uterine fibroids. Cochrane Database Syst Rev. 2001;(2):CD000547. doi: 10.1002/14651858.CD000547.
Results Reference
background
PubMed Identifier
14667994
Citation
Blithe DL, Nieman LK, Blye RP, Stratton P, Passaro M. Development of the selective progesterone receptor modulator CDB-2914 for clinical indications. Steroids. 2003 Nov;68(10-13):1013-7. doi: 10.1016/s0039-128x(03)00118-1.
Results Reference
background
PubMed Identifier
21055739
Citation
Nieman LK, Blocker W, Nansel T, Mahoney S, Reynolds J, Blithe D, Wesley R, Armstrong A. Efficacy and tolerability of CDB-2914 treatment for symptomatic uterine fibroids: a randomized, double-blind, placebo-controlled, phase IIb study. Fertil Steril. 2011 Feb;95(2):767-72.e1-2. doi: 10.1016/j.fertnstert.2010.09.059. Epub 2010 Nov 5.
Results Reference
background
PubMed Identifier
22296075
Citation
Donnez J, Tatarchuk TF, Bouchard P, Puscasiu L, Zakharenko NF, Ivanova T, Ugocsai G, Mara M, Jilla MP, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL I Study Group. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med. 2012 Feb 2;366(5):409-20. doi: 10.1056/NEJMoa1103182.
Results Reference
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Ulipristal Use in Chinese Population

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