Ulipristal Use in Chinese Population

Phase 4TerminatedNCT02825719

Queen Mary Hospital, Hong Kong31 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Interventions

Ulipristal acetateDRUG

Ulipristal acetate 5mg daily will be prescribed

Placebo pillsOTHER

Placebo pills will be prescribed

Ferrous sulphateDRUG

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

Tranexamic AcidDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Through study completion, an average of 14weeks

Secondary Outcomes

Change of haemoglobin level

The change of haemoglobin level after completion of 12 weeks course will be recorded.

Time frame: Through study completion, an average of 14weeks

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.

Time frame: Through study completion, an average of 14weeks

Intraoperative blood loss

The amount of blood loss at hysterectomy will be recorded.

Time frame: 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

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.

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

Side effects

The side effects including nausea, vomiting, headache, dyspepsia will be recorded.

Time frame: Through study completion, an average of 14weeks

Histology of the operative specimen

Presence of malignancy or hyperplasia in the operative specimen will be recorded.

Time frame: After completion of 12 weeks course of treatment

Ulipristal Use in Chinese Population

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes