NCT04132349

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

October 23, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

October 15, 2019

Last Update Submit

April 9, 2020

Conditions

Uterine FibroidHeavy Menstrual Bleeding

Keywords

Ulipristal Acetate

Outcome Measures

Primary Outcomes (1)

  • Amenorrhea

    Percentage of subjects achieve amenorrhea at the end of treatment. Amenorrhea is defined of 35 consecutive non-bleeding days, in which spotting is accepted.

    from first dose to the end of 3 consecutive months of treatment course

Secondary Outcomes (7)

  • time from treatment to amenorrhea

    from first dose to the end of 3 consecutive months of treatment course

  • uterine fibroid size change

    from first dose to the end of 3 consecutive months of treatment course

  • pelvic pain control

    from first dose to the end of 3 consecutive months of treatment course

  • adverse events

    from first dose to the end of 3 consecutive months of treatment course, and the end of 3 months follow-up without treatment

  • Uterine fibroid symptom and health - related quality of life score change

    from first dose to the end of 3 consecutive months of treatment course

  • +2 more secondary outcomes

Study Arms (1)

Ullipristal Acetate

EXPERIMENTAL

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

Drug: Ulipristal Acetate 5 mg

Interventions

Ulipristal Acetate 5 mgDRUG

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

Also known as: Esmya
Ullipristal Acetate

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

My Duc Hospital

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

LeiomyomaMenorrhagia

Interventions

ulipristal acetate

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsUterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Study Officials

  • Dang Q Vinh, MD

    Mỹ Đức Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2019

First Posted

October 18, 2019

Study Start

October 23, 2019

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

April 13, 2020

Record last verified: 2020-04

Locations

VN(1)