Uterine FibroidsPhase 3PEARLext2NCT01642472
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
A Phase 3 study testing Ulipristal Acetate - open label in people with Uterine Fibroids, run by PregLem SA at 16 sites in 4 countries.
Trial summary
This is a phase III, multicentre, long-term open-label extension of the phase III study: Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III extension (PGL09-027), patients have been exposed to a total of 4 cycles of daily 3month open-label treatment with ulipristal acetate 10mg… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- Ulipristal Acetate - open label
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 16 sitesin 4 countries
- Study dates
- Jul 2012to Apr 2015
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject completed visit F - Follow-up of Pearl III extension study (PGL09-027) - without significant deviations.
- Females of childbearing potential are advised to practice a non-hormonal method of contraception.
Who cannot join
- Subject has a history of uterus surgery (e.g. hysterectomy, myomectomy) or uterine artery embolization in Pearl III extension (PGL09-027) or afterwards that would interfere with the study assessments.
- Subject has taken or is likely to require treatment during the study with drugs that are not permitted by the study protocol.
- Subject is lactating, has a positive pregnancy test at study start or is planning a pregnancy during the course of the study.
- Subject has abnormal baseline findings, any other medical condition(s) or laboratory finding that, in the opinion of the investigator, might jeopardise the subject's safety or interfere with study evaluations.
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
Poland8 sites
Prywatna Klinika Polozniczo-Ginekologiczna
Bialystok, 15-224
INVICTA Sp. Z o.o.
Gdansk, 80-895
Private practice
Katowice, 40-724
Prywatny Gabinet Lekarski Ginekologia I Poloznictwo Ultrasonografia
Lodz, 90-602
Specjalistyczny Gabinet Ginekologiczno-Polozniczy
Lublin, 20-064
Gabinet Lekarski Specjalistyczny "Sonus"
Warsaw, 02-066
Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej
Warsaw, 02-507
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, I Katedra i Klinika Ginekologii i Położnictwa
Wroclaw, 50-369
Spain4 sites
Hospital Universitario Vall Hebrón (Gynecology department) Edificio Maternal
Barcelona, 08035
Clinica Ginecologica CEOGA
Lugo, 27002
Private Practice
Madrid, 28009
HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre
Madrid, 28041
Belgium3 sites
Cliniques Universitaires Saint-Luc, Gynécologie-Obstétrique,
Brussels, 1200
CHR de la Citadelle
Liège, 4000
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, 5530
About this study
Official title: A Phase III, Multicentre, Extension Study Investigating the Efficacy and Safety of Repeated Intermittent 3-month Courses of Open-label Administration of Ulipristal Acetate, in Subjects With Symptomatic Uterine Myomas and Heavy Uterine Bleeding
This is a phase III, multicentre, long-term open-label extension of the phase III study: Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III extension (PGL09-027), patients have been exposed to a total of 4 cycles of daily 3month open-label treatment with ulipristal acetate 10mg before entering the proposed study Pearl extension 2 (PGL11-024).
This proposed study consists of 4 further consecutive courses of 3 months (84 days) open label ulipristal acetate 10mg once daily treatment each separated by a drug free period.
- Conditions
- Uterine Fibroids
- Being tested
- Ulipristal Acetate - open label
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulipristal Acetate - open labelDrug
Also called PGL4001
Ulipristal Acetate (PGL4001) tablets 10mg orally daily for 3 months (84 days) for each treatment course. There are four 3-month treatment courses in this study.
| Study group | Role | What they receive |
|---|---|---|
| Ulipristal Acetate (PGL4001) 10mg | Experimental | Ulipristal Acetate (PGL4001)10mg daily administration Receives: Drug: Ulipristal Acetate - open label |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire
Average score of the first 3 questions.
Measured: 9 months
Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire
Average score of the first 3 questions.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- PregLem SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elke Bestel, Dr, Study director, PregLem SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642472
- Sponsor's protocol ID
- PGL11-024
- Acronym
- PEARLext2
- Status last verified
- Dec 2015
- First submitted
- 10 Jul 2012
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicentre, Extension Study Investigating the Efficacy and Safety of Repeated Intermittent 3-month Courses of Open-label Administration of Ulipristal Acetate, in Subjects With Symptomatic Uterine Myomas and Heavy Uterine Bleeding
- ClinicalTrials.gov ID
- NCT01642472
- Acronym / sponsor ID
- PEARLext2 / PGL11-024
- Conditions
- Uterine Fibroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- PregLem SAIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase III, multicentre, long-term open-label extension of the phase III study: Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III extension (PGL09-027), patients have been exposed to a total of 4 cycles of daily 3month open-label treatment with ulipristal acetate 10mg before entering the proposed study Pearl extension 2 (PGL11-024).
This proposed study consists of 4 further consecutive courses of 3 months (84 days) open label ulipristal acetate 10mg once daily treatment each separated by a drug free period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ulipristal Acetate (PGL4001) 10mg | Experimental | Drug: Ulipristal Acetate - open labelUlipristal Acetate (PGL4001)10mg daily administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject completed visit F - Follow-up of Pearl III extension study (PGL09-027) - without significant deviations.
- Females of childbearing potential are advised to practice a non-hormonal method of contraception.
Key exclusion criteria (4 listed)
- Subject has a history of uterus surgery (e.g. hysterectomy, myomectomy) or uterine artery embolization in Pearl III extension (PGL09-027) or afterwards that would interfere with the study assessments.
- Subject has taken or is likely to require treatment during the study with drugs that are not permitted by the study protocol.
- Subject is lactating, has a positive pregnancy test at study start or is planning a pregnancy during the course of the study.
- Subject has abnormal baseline findings, any other medical condition(s) or laboratory finding that, in the opinion of the investigator, might jeopardise the subject's safety or interfere with study evaluations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ulipristal Acetate - open labelAlso: PGL4001Ulipristal Acetate (PGL4001) tablets 10mg orally daily for 3 months (84 days) for each treatment course. There are four 3-month treatment courses in this study. | Drug | Ulipristal Acetate (PGL4001) 10mg |
Primary outcome
Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire
Time frame: 9 months
Average score of the first 3 questions.
Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire
Time frame: 18 months
Average score of the first 3 questions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elke Bestel, Dr study director
PregLem SA
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ulipristal Acetate - open label in people with Uterine Fibroids, run by PregLem SA at 16 sites in 4 countries.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Poland, Spain, Belgium, Austria. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire (time frame: 9 months). The study lists 2 primary outcomes in all. 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 8 Jan 2016; AzTrials last refreshed its copy on 8 Nov 2026.