Ulipristal Acetate in Symptomatic Uterine Fibroid

Mỹ Đức Hospital

Status and phase

Terminated

Phase 4

Conditions

Uterine Fibroid

Heavy Menstrual Bleeding

Treatments

Drug: Ulipristal Acetate 5 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT04132349

CS/BVMD/19/12

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

Female

Ages

18 to 48 years old

Volunteers

No Healthy Volunteers

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