Ulipristal Use in Chinese Population

Queen Mary Hospital

Status and phase: Terminated; Phase 4

Conditions: Fibroid

Treatments: Drug: Ferrous sulphate; Drug: Ulipristal acetate; Other: Placebo pills; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02825719

UW 15-022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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31 participants in 2 patient groups, including a placebo group

Ulipristal

Experimental group

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.

Treatment:

Drug: Tranexamic Acid

Drug: Ulipristal acetate

Drug: Ferrous sulphate

Placebo

Placebo Comparator group

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.

Treatment:

Other: Placebo pills

Drug: Tranexamic Acid

Drug: Ferrous sulphate