NCT02361879

Brief Summary

The uterine leiomyoma is the most common female benign disease. Submucosal fibroid are about 10%, they distort the endometrial cavity causing heavy and/or irregular bleeding (AUB) and infertility. Hysteroscopic removal of submucosal myomas improves this conditions. GnRH analogues are commonly used before hysteroscopic myomectomy to make surgery easier and safer, but they are expensive, have potential side effects and lack a robust evidence base to support this practice. Ulipristal acetate treatment was able and faster to control in 90% of cases uterine bleeding associated with fibroids than GnRH agonists. UPA significantly improved quality of life and pain reduction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

2.6 years

First QC Date

February 2, 2015

Last Update Submit

November 17, 2016

Conditions

Fibroid

Keywords

fibroidsgnrh analogueulipristal acetatehysteroscopy

Outcome Measures

Primary Outcomes (1)

  • Uterine bleeding assessed by pictorial blood-loss assessment chart (PBAC)

    To compare the proportion of controlled uterine bleeding in patients with submucous myoma preoperatively treated by ulipristal acetate or by GnRh-a

    90 days after the beginning of the treatment

Secondary Outcomes (4)

  • Feasibility of myoma hysteroscopic resection (VAS score)

    Within 2 hours after the end of the hysteroscopy

  • Operative time

    Within 2 hours after the end of the hysteroscopy

  • Haemoglobin concentration

    The day before and 3 hours after the hysteroscopy

  • Fluid absorption

    Within 2 hours after the end of the hysteroscopy

Study Arms (2)

Ulipristal acetate

EXPERIMENTAL

Womens will be treated with 5 mg/day of oral ulipristal acetate for 3 months

Drug: ulipristal acetate

Leuprolile acetate

ACTIVE COMPARATOR

women will be treated with 1 IM injection of leuprolide acetate 11,25 mg in in the luteal phase

Drug: Leuprolide acetate

Interventions

ulipristal acetateDRUG

5 mg/day will be administered starting from day 1 of the cycle and up to three months later

Also known as: Esmya
Ulipristal acetate
Leuprolide acetateDRUG

One dose of 11.25 GnRH analogue depot will be administered in the luteal phase of the menstrual cycle (days 21-24)

Also known as: Enantone 11.25
Leuprolile acetate

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Pugliese-Ciaccio

Catanzaro, Catanzaro, 88100, Italy

RECRUITING

MeSH Terms

Conditions

Leiomyoma

Interventions

ulipristal acetateLeuprolide

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Fulvio Zullo, MD,PhD

    Magna Graecia University of Catanzaro

    STUDY DIRECTOR

  • Roberta Venturella, MD

    Magna Graecia University of Catanzaro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fulvio Zullo, MD,PhD

CONTACT

00390961883234zullo@unicz.it

Roberta Venturella, MD

CONTACT

00390961883401rovefa@libero.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 12, 2015

Study Start

February 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations

IT(1)