Ulipristal Use in Chinese Population

Fibroid Clinical Trial

Official title:

Pilot Study on the Pre-operative Use of Ulipristal on Fibroid in Chinese Population

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02825719
• Other study ID #: UW 15-022
• Status: Terminated
• Phase: Phase 4
• Start date: December 2, 2015
• Est. completion date: March 31, 2020

Study information

• Verified date: April 2020
• Source: Queen Mary Hospital, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibroid
• Leiomyoma

Intervention

Drug:
• Ulipristal acetate
Ulipristal acetate 5mg daily will be prescribed

Other:
• Placebo pills
Placebo pills will be prescribed

Drug:
• Ferrous sulphate
Ferrous sulphate 300mg three times a day will be prescribed if haemoglobin level is less than 10g/dL.
• Tranexamic Acid
Tranexamic Acid 500mg four times a day on request basis will be prescribed if patient complained of menorrhagia.

Locations

Country	Name	City	State
Hong Kong	Department of Obstetrics and Gynaecology, Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (7)

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. — View 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. 2 — View Citation

Jacobson GF, Shaber RE, Armstrong MA, Hung YY. Hysterectomy rates for benign indications. Obstet Gynecol. 2006 Jun;107(6):1278-83. — View 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):1041-8. doi: 10.1097/AOG.0b013e3181b9d222. — View 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. Review. Update in: Cochrane Database Syst Rev. 2017 Nov 15;11:CD000547. — View 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. — View Citation

Parker WH. Etiology, symptomatology, and diagnosis of uterine myomas. Fertil Steril. 2007 Apr;87(4):725-36. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of haemoglobin level	The change of haemoglobin level after completion of 12 weeks course will be recorded.	Through study completion, an average of 14weeks
Secondary	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.	Through study completion, an average of 14weeks
Secondary	Intraoperative blood loss	The amount of blood loss at hysterectomy will be recorded.	After completion of 12 weeks course, the intraoperative blood loss at the time of performance of hysterectomy will be assessed.
Secondary	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.	After completion of 12 weeks course of treatment and before the scheduled operation
Secondary	Side effects	The side effects including nausea, vomiting, headache, dyspepsia will be recorded.	Through study completion, an average of 14weeks
Secondary	Histology of the operative specimen	Presence of malignancy or hyperplasia in the operative specimen will be recorded.	After completion of 12 weeks course of treatment