AzTrials
AzTrials

FibroidPhase 4NCT02357563

Ulipristal Acetate Versus GnRH Analogue and Myometrial Preservation

A Phase 4 study testing ulipristal acetate and Leuprolide acetate in people with Fibroid, run by University Magna Graecia at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Fibroid
What is being tested?
ulipristal acetate and Leuprolide acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteItaly
Study dates
Feb 2015to Sep 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Fulvio Zullo, MD,PhD contact

00390961883234

zullo@unicz.it

Roberta Venturella, MD contact

00390961883401

rovefa@libero.it

Italy1 site, 1 recruiting
  • Azienda Ospedaliera Pugliese-Ciaccio

    Catanzaro, Catanzaro, 88100

    Fulvio Zullo, 00390961883234, zullo@unicz.it

    Roberta Venturella, MD

    Recruiting

Other trials in Italy

About this study

Official title: Ulipristal Acetate Versus GnRH Analogue for Myometrial Preservation in Patients With Submucosal Uterine Leiomyoma G2

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.

Conditions
Fibroid
Being tested
ulipristal acetate, Leuprolide acetate
Keywords
fibroid, GnRH analogue, ulipristal acetate
Medical subject headings
Leiomyoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ulipristal acetateDrug

    Also called Esmya

    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

  • Leuprolide acetateDrug

    Also called Enantone 11.25

    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

Study groups in NCT02357563
Study groupRoleWhat they receive
Ulipristal acetateExperimentalWomen will be treated with an oral dose of ulipristal acetate 5 mg/day for 2 courses of 3 months each
Receives: Drug: ulipristal acetate
Leuprolile acetateActive comparatorWomen will be treated with an injection IM on leuprolide acetate 11,25 in the luteal phase repeated 3 months later
Receives: Drug: Leuprolide acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year after treatment

Secondary outcomes (3)
  1. Time to pregnancy

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

    Measured: 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

    Measured: 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.

    Measured: 24 weeks after the first dose of drugs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionSep 2017 (estimated)
  4. Study completionSep 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02357563
Sponsor's protocol ID
UPA myometrial
Status last verified
Nov 2016
First submitted
2 Feb 2015
Last updated
18 Nov 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ulipristal acetate and Leuprolide acetate in people with Fibroid, run by University Magna Graecia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fulvio Zullo, MD,PhD (00390961883234, zullo@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of restored uterine cavity 1 year after enrollment (time frame: 1 year after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2016.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in