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Status unknownNCT02357563Updated Nov 18, 2016

Ulipristal Acetate Versus GnRH Analogue and Myometrial Preservation

A Phase 4 interventional study of ulipristal acetate and Leuprolide acetate in Fibroid, sponsored by University Magna Graecia. Status unknown at 1 site in Italy. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-18.

Sponsored by University Magna Graecia · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
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Study 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

Read the detailed description

Uterine leiomyoma is the most common benign tumor of the female genital tract. Submucosal fibroid are about 10% of all uterine myoma. They grow inside the uterine cavity and are usually associated with menorrhagia, abnormal uterine bleeding (AUB) and infertility. According to the degree of myometrial penetration, the European Society for Gynaecological Endoscopy (ESGE) classified submucosal myomas in Type 0 (G0, totally intracavitary fibroids), Type I (G1, \<50% myometral penetration), or Type II (G2, >50% myometral penetration).

Hysteroscopic removal of submucosal myomas improves menorrhagia and AUB but can be challenging in women with Type II (G2) fibroids, since they often require more and more surgeries due to their particular position in the context of myometrium. Surgery, moreover, should always be tailored, particularly in patients wishing to conceive, to preserve the integrity of the myometrium. In this particular population, indeed, the possibility of avoiding any kind of uterine surgery should always be exploited. Up to now, hysteroscopic resection of submucosal fibroids is considered the gold standard for symptomatic patients, since no medication has been able to restore uterine cavity in a permanent manner. In this setting, use of a GnRH agonist before surgery is still a matter of debate, but literature reports that preoperative use of GnRH agonist appears to be relevant and beneficial in patients with submucous fibroids. Benefits include a resolution of preoperative anemia, a decrease in fibroid size, a reduction of endometrial thickness and vascularization with subsequently improved visibility and reduced fluid absorption, and the possibility of surgical scheduling.

Conversely, this preoperative treatment is associated with some side effects such as hot flushes and postinjection endometrial bleeding due to the flare-up effect.

Data on SPRM showed that 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%. In the subpopulation of patients not undergoing surgery, fibroid volume reduction appeared to be maintained for 6 months after the end of UPA treatment.

This was in contrast to patients receiving a GnRH agonist, in whom fibroids began to regrow 1 to 3 months after the last dose, reaching their baseline size after 6 months.

No sub-analysis have been conducted on submucosal fibroids, but is of interest to underline that, when myomas regress so much that they no longer distort the uterine cavity, surgery may not be required. This could represent a safe way to avoid surgery in patients with G2 fibroids desiring pregnancy.

02

Conditions studied

  • Fibroid

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Keywords

  • fibroid
  • GnRH analogue
  • ulipristal acetate
03

In context

Leiomyoma

490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.

This study's planned enrollment of 110 is above the median of 62 across 345 interventional studies indexed under Leiomyoma.

Browse Leiomyoma studies →

Lead sponsor

University Magna Graecia is the lead sponsor of 75 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    Ulipristal acetate

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

    Drug: ulipristal acetate

  • Active comparator
    Leuprolile acetate

    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

  • Drugulipristal acetate

    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

  • DrugLeuprolide acetate

    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

06

What researchers measure

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

    Time frame: 1 year after treatment

Secondary outcomes

  1. Time to pregnancy

    to compare time to pregnancy in patients treated with Ulipristal Acetate and GnRH-a

    Time frame: from the end of treatment to the obtainance of pregnancy

  2. Live birth rate

    to compare live birth rate in patients treated with Ulipristal Acetate and GnRH-a

    Time frame: A the time of delivery

  3. Proportion of patients needing surgery after UPA or GnRH-a

    to compare need for surgery in patients treated with Ulipristal Acetate and GnRH-a.

    Time frame: 24 weeks after the first dose of drugs

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Study locations

1 of 1 sites recruiting
  • Azienda Ospedaliera Pugliese-Ciaccio
    Catanzaro, 88100, Italy
    • Fulvio Zullo · Contact · zullo@unicz.it · 00390961883234
    • Roberta Venturella, MD · Principal investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02357563
Lead sponsor
University Magna Graecia
Responsible party
Fulvio Zullo (Full professor, University Magna Graecia) — Principal investigator
First posted
Feb 6, 2015
Start date
Feb 2015
Primary completion
Sep 2017 (estimated)
Completion
Sep 2017 (estimated)
Last update
Nov 18, 2016

Study contacts

Fulvio Zullo, MD,PhD
Contact
zullo@unicz.it
00390961883234
Roberta Venturella, MD
Contact
rovefa@libero.it
00390961883401
Fulvio Zullo, MD,PhD
study director · Magna Graecia University of Catanzaro
Roberta Venturella, MD
principal investigator · Magna Graecia University of Catanzaro

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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