NCT04132349

Ulipristal Acetate in Symptomatic Uterine Fibroid

The Effectiveness and Safety of Ulipristal Acetate in Women With Symptomatic Uterine Fibroid

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Mỹ Đức Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effectiveness and safety of ulipristal acetae (UPA) in women with symptomatic uterine fibroids. Those who fulfilled inclusion/exclusion criteria will be treated UPA at daily dose of 5mg.

Detailed description

There is increasing evidence approving role of medical therapy in treatment of symptomatic uterine fibroid, in the context of women's desire to preserve fertility or not to undergo operation. Among these hormonal therapies, ulipristal acetate (UPA) is an orally administered selective progesterone receptor modulator commonly prescribed for treatment of uterine fibroid. This agent acts on causing apoptosis of the muscle cells inside the tumor and reducing the tumor matrix in case of uterine fibroid. UPA at daily dose of 5 mg has been shown to decrease menstrual blood loss and reduce tumor size after 13 consecutive weeks of treatment.

Conditions

• Uterine Fibroid
• Heavy Menstrual Bleeding

Interventions

Type	Name	Description
DRUG	Ulipristal Acetate 5 mg	Ulipristal acetate (from Cenexi manufacturer, France) at daily dose of 5mg in 3 consecutive months course

Timeline

• Start date: 2019-10-23
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2019-10-18
• Last updated: 2020-04-13

Locations

1 site across 1 country: Vietnam