Ulipristal Use in Chinese Population

NCT02825719 | Terminated Phase 4

• 1 other identifier: UW 15-022
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibroid

Keywords

Fibroid; Ulipristal; Selective progesterone receptor modulator; Chinese

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 14weeks

Secondary Outcomes (6)

• Change of haemoglobin level

  Through study completion, an average of 14weeks

• Change of fibroid volume

  Through study completion, an average of 14weeks

• Intraoperative blood loss

  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

  After completion of 12 weeks course of treatment and before the scheduled operation

• Side effects

  Through study completion, an average of 14weeks

Study Arms (2)

Ulipristal

EXPERIMENTAL

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.

Drug: Ulipristal acetate; Drug: Ferrous sulphate; Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo pills; Drug: Ferrous sulphate; Drug: Tranexamic Acid

Interventions

Ulipristal acetate DRUG

Ulipristal acetate 5mg daily will be prescribed

Also known as: Esyma

Ulipristal

Placebo pills OTHER

Placebo pills will be prescribed

Placebo

Ferrous sulphate DRUG

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

Also known as: Ferasul

Placebo; Ulipristal

Tranexamic Acid DRUG

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

Also known as: Transamin

Placebo; Ulipristal

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary Hospital, Hong Kong: lead

Study Sites (1)

Department of Obstetrics and Gynaecology, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (7)

• 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.

  PMID: 17430732 BACKGROUND

• 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.

  PMID: 16738152 BACKGROUND

• 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.

  PMID: 20168105 BACKGROUND

• 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.

  PMID: 11405968 BACKGROUND

• 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.

  PMID: 14667994 BACKGROUND

• 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.

  PMID: 21055739 BACKGROUND

• 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.

  PMID: 22296075 RESULT

MeSH Terms

Conditions

Leiomyoma

Interventions

ulipristal acetate; ferrous sulfate; Tranexamic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Ernest H. Y. Ng

  The University of Hong Kong

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 29, 2016
• First Posted: July 7, 2016
• Study Start: December 2, 2015
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)