Uterine MyomasPhase 3PEARLIINCT00740831
PGL4001 Versus GnRH-agonist in Uterine Myomas
A Phase 3 study testing PGL4001 and leuprorelin in people with Uterine Myomas, run by PregLem SA at 46 sites in 9 countries.
Trial summary
This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Uterine Myomas
- What is being tested?
- PGL4001 and leuprorelin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 46 sitesin 9 countries
- Study dates
- Aug 2008to Jun 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Be a pre-menopausal woman between 18 and 50 years inclusive.
- Have excessive uterine bleeding due to myoma
- Have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size
- Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
- If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
- Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.
Who cannot join
- Has a history of or current uterine, cervical, ovarian or breast cancer.
- Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
- Has a known severe coagulation disorder.
- Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.
- Has a history of or known current osteoporosis.
- Has abnormal hepatic function at study entry.
Show all 9Show fewer
- Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.
- Has a current (within twelve months) problem with alcohol or drug abuse.
- Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
Trial locations and contacts
46 sites in 9 countries.
46 sites in 9 countries
Spain9 sites
Institut Universitari Dexeus
Barcelona, 08028
Hospital Universitario Vall d'Hebrón
Barcelona, 08035
Hospital Clínic i Provincial
Barcelona, 08036
Clínica Ginecológica CEOGA
Lugo, 27002
Private Practice
Madrid, 28009
Hospital Universitario Doce de Octubre
Madrid, 28041
Hospital Virgen de la Arrixaca Servicio de Ginecología Carretera Madrid-Cartagena
Murcia, 30120
Hospital Universitaris La Fe
Valencia, 46009
Hospital Universitario Dr. Peset
Valencia, 46017
Germany8 sites
Klinik für Gynäkologie und Geburtshilfe
Chemnitz
Universitätsklinikum Köln Klinik und poliklinik für Frauenheilkunde und Geburtshilfe
Cologne, 50931
Private Practice
Frankfurt, 60322
Medizinische Hochschule Hannover, Frauenklinik, Abt. I für Frauenheilkunde und Geburtshilfe,
Hanover, 30625
Universität zu Lübeck, Klinik für Gynäkologie und Geburtshilfe
Lübeck, 23538
Poliklinik fur Frauenheilkunde und Geburtshilfe
Münster, 48149
Universitätsklinikum Tübingen
Tübingen, 72076
Ammerland-Klinik GmbH Frauenklinik
Westerstede, 26655
Italy7 sites
Clinica Ostetrica e Ginecologica II - Università degli Studi di Bari
Bari
Clinica Obstetrica - Azienda Ospedaliera Universitaria di Cagliari
Cagliari
Azienda Ospedaliera S. Gerardo - U. O. Ostetricia e Ginecologia
Monza
Policlinico Universitario Federico II
Naples
Universita di Padova-Dip scienze ginecologiche e della riproduzione umana
Padova
Clinica Ostetrica e Ginecologica - A. O. U. Policlinico Paolo Giaccone
Palermo, 70100
Policlinico Universitario "Agostino Gemelli"
Roma, 00168
Israel6 sites
Soroka University Medical Center, Division of Obstetrics & Gynecology
Beersheba, 84101
Hadassah University Hospital
Jerusalem, 91120
Hadassah University Hospital, Mount Scopus
Jerusalem
Meir Medical Center
Kfar Saba
Western Galilee Hospital Nahariya
Nahariya, 22100
Rabin Medical Center, Helen Schneider Hospital for Women
Petah Tikva, 49100
Poland5 sites
Prywatna Klinika Polozniczo-Ginekologiczna
Bialystok, 15-224
INVICTA Sp. Z o.o.
Gdansk, 80-895
Private Practice
Katowice, 40-084
Samodzielny Publiczny Szpital Klinika Ginekologii Onkologicznej i Ginekologii
Lublin, 20-081
Gabinet Lekarski Specjalistyczny "Sonus"
Warsaw, 02-066
Austria4 sites
Medical University Graz
Graz, 8036
Medical University of Innsbruck
Innsbruck, 6020
Landesklinikum Thermenregion Neunkirchen; Dept. For Gynecology
Neunkirchen, 2620
Medical University Vienna
Vienna, 1090
Belgium4 sites
Hopital Erasme, Department of Obstetrics and Gynecology,
Brussels, 1070
Clinique Universitaire St-Luc
Brussels, 1200
CHR de la Citadelle
Liège, 4000
Clinique Universitaire de Mont-Godinne
Yvoir, 5530
France2 sites
Cabinet de Gynécologie Chirurgicale
Bordeaux, 33000
CHU de Clermont-Ferrand - Polyclinique Gynécologie-Obstétrique
Clermont-Ferrand, 63058
Netherlands1 site
University Medical Center Utrecht, Gynecologist Reproductive Medicine and Surgery, Division for Reproductive Medicine
Utrecht, 3584 CX
About this study
Official title: A Phase III, Randomised, Parallel Group, Double-blind, Double-dummy, Active Comparator-controlled, Multicenter Study to Assess the Efficacy and Safety of PGL4001 vs GnRH-agonist for Pre-operative Ttt of Symptomatic Uterine Myomas
This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.
- Conditions
- Uterine Myomas
- Being tested
- PGL4001, leuprorelin
- Keywords
- Uterine Myomas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PGL4001Drug
Also called Ulipristal acetate
tablets
leuprorelinDrug
Also called GnRH-agonist
solution for injection
| Study group | Role | What they receive |
|---|---|---|
| A (PGL4001 5 mg) | Experimental | Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection) Receives: Drug: PGL4001 |
| B (PGL4001 10mg) | Experimental | Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection) Receives: Drug: PGL4001 |
| C (GnRH-agonist) | Active comparator | PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection) Receives: Drug: leuprorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit)
Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.
Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.
A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.
Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.
The week 13 PBAC score was calculated using the last 28 days of treatment.
Measured: 3 months
Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist
Measured by log 10 (log pg/ml) transformed values for estradiol (E2) in blood samples
Measured: Week 13 visit
Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist
Difference in percentage of subjects reporting moderate or severe hot flushes:
Frequency and severity of this adverse event(as spontaneously reported by patients or elicited by nonleading questions) were recorded on standard forms at every visit up to week 17.
Measured: Up to week 17
Secondary outcomes (1)
Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13
Assessment of PGL4001 capacity to decrease volume of the three largest myomas was performed at each center by means of ultrasonography at baseline and at week 13.
The total volume of the three largest myomas assessed at screening and at end-of-treatment visit (Week 13) was analysed on a logarithm transformed scale (to base 10).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionJan 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine MyomasStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- PregLem SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Elke Bestel, Study director, PregLem SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740831
- Sponsor's protocol ID
- PGL07-022
- Acronym
- PEARLII
- Status last verified
- Dec 2012
- First submitted
- 22 Aug 2008
- Last updated
- 17 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Donnez J, Tomaszewski J, Vazquez F, Bouchard P, Lemieszczuk B, Baro F, Nouri K, Selvaggi L, Sodowski K, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL II Study Group. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med. 2012 Feb 2;366(5):421-32. doi: 10.1056/NEJMoa1103180.
PubMed 22296076
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomised, Parallel Group, Double-blind, Double-dummy, Active Comparator-controlled, Multicenter Study to Assess the Efficacy and Safety of PGL4001 vs GnRH-agonist for Pre-operative Ttt of Symptomatic Uterine Myomas
- ClinicalTrials.gov ID
- NCT00740831
- Acronym / sponsor ID
- PEARLII / PGL07-022
- Conditions
- Uterine Myomas
- Keywords
- Uterine Myomas
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- PregLem SAIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 25 Aug 2008 (estimated)
- Results
- Posted 16 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A (PGL4001 5 mg) | Experimental | Drug: PGL4001Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection) |
| B (PGL4001 10mg) | Experimental | Drug: PGL4001Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection) |
| C (GnRH-agonist) | Active comparator | Drug: leuprorelinPGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Be a pre-menopausal woman between 18 and 50 years inclusive.
- Have excessive uterine bleeding due to myoma
- Have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size
- Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
- If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
Key exclusion criteria (9 listed)
- Has a history of or current uterine, cervical, ovarian or breast cancer.
- Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
- Has a known severe coagulation disorder.
- Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.
- Has a history of or known current osteoporosis.
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 |
|---|---|---|
| PGL4001Also: Ulipristal acetatetablets | Drug | A (PGL4001 5 mg), B (PGL4001 10mg) |
| leuprorelinAlso: GnRH-agonistsolution for injection | Drug | C (GnRH-agonist) |
Primary outcome
Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit)
Time frame: 3 months
Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss. Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding. A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5. Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used. The week 13 PBAC score was calculated using the last 28 days of treatment.
Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist
Time frame: Week 13 visit
Measured by log 10 (log pg/ml) transformed values for estradiol (E2) in blood samples
Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist
Time frame: Up to week 17
Difference in percentage of subjects reporting moderate or severe hot flushes: Frequency and severity of this adverse event(as spontaneously reported by patients or elicited by nonleading questions) were recorded on standard forms at every visit up to week 17.
1 secondary outcome
Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22296076Donnez J, Tomaszewski J, Vazquez F, Bouchard P, Lemieszczuk B, Baro F, Nouri K, Selvaggi L, Sodowski K, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL II Study Group. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med. 2012 Feb 2;366(5):421-32. doi: 10.1056/NEJMoa1103180.
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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.
Dr Elke Bestel study director
PregLem SA
46 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PGL4001 and leuprorelin in people with Uterine Myomas, run by PregLem SA at 46 sites in 9 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 6 inclusion and 9 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 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Spain, Germany, Italy, Israel, Poland and 4 more countries. 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?
Yes. Results are posted in the registry (first posted 16 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit) (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00740831, which also lists 1 linked publication.
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 17 Dec 2012.