Ulipristal Acetate in Symptomatic Uterine Fibroid

NCT ID: NCT04132349

Last Updated: 2020-04-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-23
• Study Completion Date: 2020-04-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ullipristal Acetate

Women with symptomatic uterine fibroids will be treated with 5 mg UPA / day in 3 months

Group Type: EXPERIMENTAL

Ulipristal Acetate 5 mg

Intervention Type: DRUG

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

Interventions

Ulipristal Acetate 5 mg

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

Intervention Type: DRUG

Other Intervention Names

Esmya

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mỹ Đức Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dang Q Vinh, MD

Role: PRINCIPAL_INVESTIGATOR

Mỹ Đức Hospital

Locations

My Duc Hospital

Ho Chi Minh City, , Vietnam

Countries

Vietnam

Other Identifiers

CS/BVMD/19/12

Identifier Type: -

Identifier Source: org_study_id