Fibroid Clinical Trial
Official title:
Pilot Study on the Pre-operative Use of Ulipristal on Fibroid in Chinese Population
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.
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