Efficacy of ulipristal for treatment of women with symptomatic uterine fibroids

Uterine fibroids or leiomyomas are benign uterine neoplasms that arise from the smooth- muscle tissue.They constitute the most common tumor in women,being present in 20-40% of women of reproductive age.Ulipristal acetate a selective progesterone receptor modulator, is a new ,effective option for medical management of symptomatic uterine fibroids in women of reproductive age.
Aim: The purpose of the study was to study the efficacy of ulipristal acetate for treatment of symptomatic uterine fibroids.
Objectives:
1. To evaluate improvement in symptoms of menorrhagia and dysmenorrhea in women with fibroids after Ulipristal treatment
2. To evaluate reduction in size of fibroid by USG measurements after Ulipristal treatment.
3. Increase in haemoglobin of anemic women at the end of Ulipristal treatment course
4. Assessment of adverse event/side effects.
Study Design: Hospital based observational analytical study/open labeled uncontrolled clinical trial with prospective data collection.
Setting: This study was conducted in Asian Institute Of Medical Sciences,Faridabad
Methods: Women with of uterine fibroid associated symptom were included in the study after obtaining written informed consent.women were administered Ulipristal(5mg) starting from first day of menstrual cycle daily for 90 days and followed up monthly for a period of 6 months,
Result: 90 women were selected for the study out of which 12 dropped out and 2 women got operated in view of increase in size of fibroid and heavy bleeding. During the course of treatment amenorrhoea was achieved in 72 out of 78 patients (92.3%). Dysmenorrhoea was relieved in 47.8% of women,with a much higher relief in menstrual blood loss,94.6% as per PBAC score. The mean volume of the dominant fibroid prior to treatment was 194.29 cc and decreased to 141.53cc after three month treatment period indicating significantly lower volume after treatment. The mean haemoglobin level increased from an initial level of 9.8g/dl(6.7-13g/dl) to 12.7g/dl(10 -13.8g/dl) after three months of ulipristal acetate therapy.No major side effects of the drugs were noticed during the course of treatment.
Conclusions: Three months of ulipristal acetate therapy causes significant reduction in uterine bleeding,fibroid volume with improvement of haemoglobin level without any significant side effect.