Clinical trial · Interventional
Ulipristal Use in Chinese Population
Pilot Study on the Pre-operative Use of Ulipristal on Fibroid in Chinese Population
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Ulipristal was withdrawal from the market
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibroid | Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ferrous sulphate | Drug | — | UNRESOLVED |
| Placebo pills | Other | — | UNRESOLVED |
| Tranexamic Acid | Drug | — | UNRESOLVED |
| Ulipristal acetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ulipristal
- 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.
- interventionNames
- Drug: Ulipristal acetate
- Drug: Ferrous sulphate
- Drug: Tranexamic Acid
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- 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.
- interventionNames
- Other: Placebo pills
- Drug: Ferrous sulphate
- Drug: Tranexamic Acid
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDParker 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
- BACKGROUNDJacobson 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
- BACKGROUNDJacoby 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
- BACKGROUNDLethaby 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
- BACKGROUNDBlithe 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
- BACKGROUNDNieman 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
- RESULTDonnez 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.