- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02825719
Ulipristal Use in Chinese Population
Pilot Study on the Pre-operative Use of Ulipristal on Fibroid in Chinese Population
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- Department of Obstetrics and Gynaecology, Queen Mary Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Ulipristal acetate 5mg daily will be prescribed
Other Names:
Ferrous sulphate 300mg three times a day will be prescribed if haemoglobin level is less than 10g/dL.
Other Names:
Tranexamic Acid 500mg four times a day on request basis will be prescribed if patient complained of menorrhagia.
Other Names:
|
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:
Tranexamic Acid 500mg four times a day on request basis will be prescribed if patient complained of menorrhagia.
Other Names:
Placebo pills will be prescribed
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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
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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.
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Through study completion, an average of 14weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of haemoglobin level
Time Frame: Through study completion, an average of 14weeks
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The change of haemoglobin level after completion of 12 weeks course will be recorded.
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Through study completion, an average of 14weeks
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Change of fibroid volume
Time Frame: Through study completion, an average of 14weeks
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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.
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Through study completion, an average of 14weeks
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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.
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The amount of blood loss at hysterectomy will be recorded.
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After completion of 12 weeks course, the intraoperative blood loss at the time of performance of hysterectomy will be assessed.
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Conversion to less invasive intervention options
Time Frame: After completion of 12 weeks course of treatment and before the scheduled operation
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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.
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After completion of 12 weeks course of treatment and before the scheduled operation
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Side effects
Time Frame: Through study completion, an average of 14weeks
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The side effects including nausea, vomiting, headache, dyspepsia will be recorded.
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Through study completion, an average of 14weeks
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Histology of the operative specimen
Time Frame: After completion of 12 weeks course of treatment
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Presence of malignancy or hyperplasia in the operative specimen will be recorded.
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After completion of 12 weeks course of treatment
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ernest H. Y. Ng, The University of Hong Kong, HONG KONG
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Connective Tissue Diseases
- Neoplasms, Connective Tissue
- Neoplasms, Muscle Tissue
- Leiomyoma
- Myofibroma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Fibrin Modulating Agents
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Tranexamic Acid
- Ulipristal acetate
Other Study ID Numbers
- UW 15-022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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