Ulipristal Acetate in Symptomatic Uterine Fibroid

• Status: Terminated
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: Female

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.

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

Details

• Lead Sponsor: Mỹ Đức Hospital
• Collaborator: HOPE Research Center, Ho Chi Minh City, Viet Nam
• Treatments: Ulipristal acetate

Criteria

Inclusion Criteria:

• Women aged 18-48

• Regular cycle of 22-35 days interval and FSH <=20 mUI/mL.

• >=1 uterine fibroid of 3<= d < 10cm (regardless of location), diagnosed by transvaginal ultrasound.

• Heavy menstrual bleeding (blood loss >80ml/cycle).

• Uterine size < 16 weeks of GA on clinical examination.

• Agree to participate in the study.

Exclusion Criteria:

• Previous or current treatment of uterus, cervix, ovarian or breast cancer.

• Previous endometrial ablation or uterine artery embolization.

• Abnormal PAP's smear result within 12 months prior to recruitment.

• Endometrial hyperplasia within 6 months prior to recruitment.

• Uterine polyp >2cm.

• Ovarian cysts 4cm diagnosed by transvaginal ultrasound.

• Severe anemia (Hb 6 g/dl) or indication for blood transfusion.

• Coagulation disorder indicated for treatment.

• Increased liver enzyme level of twofold or more than normal upper limit.

• Previous use of SPRM.

• Treatment of systemic progestin or intrauterine device or hormonal contraception within 2 months, or use of GnRH analogue within 5 months prior to recruitment.

• Current use of acetylsalicylic acid, mefenamic acid, anticoagulation agents, antifibrinolysis agents, or systemic corticoid