NCT02357563

Brief Summary

Submucosal fibroid grow inside the uterine cavity and are associated with menorrhagia, abnormal uterine bleeding (AUB) and infertility. Type II (G2) fibroids often require more surgeries due to their particular position in the myometrium. Surgery, moreover, should always be tailored, particularly in patients wishing to conceive, to preserve the integrity of the myometrium. Preoperative use of GnRH agonist appears to be relevant and beneficial in patients with submucous fibroids, but are associated with several side effects. the eighty percent of patients treated by UPA showed a clinically meaningful reduction of more than 25% in fibroid volume, and 50% of patients a reduction of 50%. fibroid volume reduction appeared to be maintained for 6 months after the end of UPA treatment

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
110

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

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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
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 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

fibroidGnRH analogueulipristal acetate

Outcome Measures

Primary Outcomes (1)

  • Proportion of restored uterine cavity 1 year after enrollment

    To compare the proportion of patients, treated by UPA or by GnRh-a, with uterine cavity no longer distorted by their submucous myoma

    1 year after treatment

Secondary Outcomes (3)

  • Time to pregnancy

    from the end of treatment to the obtainance of pregnancy

  • Live birth rate

    A the time of delivery

  • Proportion of patients needing surgery after UPA or GnRH-a

    24 weeks after the first dose of drugs

Study Arms (2)

Ulipristal acetate

EXPERIMENTAL

Women will be treated with an oral dose of ulipristal acetate 5 mg/day for 2 courses of 3 months each

Drug: ulipristal acetate

Leuprolile acetate

ACTIVE COMPARATOR

Women will be treated with an injection IM on leuprolide acetate 11,25 in the luteal phase repeated 3 months later

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 for two courses, with an interval between the courses of 1 month

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) and repeated 3 months later

Also known as: Enantone 11.25
Leuprolile acetate

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • G2 submucosal leiomyoma \<3 cm, symptoms of menomethrorragia, menstrual disorder, infertility, pelvic pain

You may not qualify if:

  • submucosal leyomyoma other than G2 or greater than 3 cm, intramural or subserosal leiomyomas endometrial hyperplasia with atypia history of uterine surgery

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
DOUBLE
Who Masked
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 6, 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)