Ulipristal Use in Chinese Population

• Status: Terminated
• Trial end date: 2020-03-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queen Mary Hospital, Hong Kong
• Treatments: Tranexamic Acid; Ulipristal acetate

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