Clinical trial NCT02825719: Ulipristal Use in Chinese Population
Official title: Pilot Study on the Pre-operative Use of Ulipristal on Fibroid in Chinese Population
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Fibroid
Keywords: Fibroid
Ulipristal
Selective progesterone receptor modulator
Chinese
Lead sponsor: Queen Mary Hospital, Hong Kong
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of uterine bleeding
timeFrame: Through study completion, an average of 14weeks
Secondary outcomes:
measure: Change of haemoglobin level
timeFrame: Through study completion, an average of 14weeks
measure: Change of fibroid volume
timeFrame: Through study completion, an average of 14weeks
measure: Intraoperative blood loss
timeFrame: After completion of 12 weeks course, the intraoperative blood loss at the time of performance of hysterectomy will be assessed.
measure: Conversion to less invasive intervention options
timeFrame: After completion of 12 weeks course of treatment and before the scheduled operation
measure: Side effects
timeFrame: Through study completion, an average of 14weeks
measure: Histology of the operative specimen
timeFrame: After completion of 12 weeks course of treatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Obstetrics and Gynaecology, Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong, HONG KONG
name: Ernest H. Y. Ng
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.