NCT02361905

Brief Summary

Cellular leiomyomas (CLs) are described as leiomyomas that are significantly more cellular than the surrounding myometrium, often with crowding and overlapping of nuclei. they often are soft and appear more tan or yellow and less circumscribed than the usual leiomyomas. Pre-operatively CLs can be recognized at ultrasound evaluation because they appear as hypoechoic uterine lesions. patients with hypoechoic myoma have a significantly longer surgery time after treatment with a gonadotropin-releasing hormone (GnRH) analog probably related to degenerative changes induced by this treatment. Hypoechoic CLs should be more responsive to ulipristal acetate treatment than common leiomyomas. The antiproliferative ulipristal effect, moreover, induces a condition of apoptotic necrosis that, compared to GnRH-a myxoid necrosis, probably allows an easier surgical enucleation of the tumor.

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
42

participants targeted

Target at P25-P50 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

fibroidcellular leiomyomasGnRH analogueulipristal acetate

Outcome Measures

Primary Outcomes (1)

  • Operative time (minutes)

    To evaluate the difference in terms of operative times in patients with hypoechoic CLs submitted to laparoscopic myomectomy and preoperatively treated by ulipristal acetate or GnRh-a .

    At the time of skin closure at the end of the myomectomy

Secondary Outcomes (3)

  • Difficulty of leiomyoma enucleation assessed by surgeon on a VAS scale

    Within 2 hours after the end of the myomectomy

  • Intraoperative blood loss (delta Hb)

    The day before surgery and 3 hours after the myomectomy

  • Post-operative evaluation of leiomyomas characteristics

    At the time of pathological assessment

Study Arms (2)

Ulipristal acetate

EXPERIMENTAL

women will be treated with an oral dose of ulipristal acetate 5 mg/day for 3 months

Drug: ulipristal acetate

Leuprolile acetate

ACTIVE COMPARATOR

Women will be treated with an intramuscular (IM) injection of leuprolide acetate 11.25 mg 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)

You may qualify if:

  • hypoechoic uterine leiomyoma (echogenicity \<3),
  • intramural leiomyomas with an ultrasonographic size \<20 cm but \>4cm,
  • indication to surgery (symptoms of menometrorrhagia,
  • menstrual disorder,
  • infertility,
  • pelvic pain or pelvic pressure

You may not qualify if:

  • submucosal leiomyoma,
  • 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

    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 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)