Uterine FibroidsPhase 3PEARLIIINCT01156857
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
A Phase 3 study testing PGL4001, progestin in people with Uterine Fibroids, run by PregLem SA at 23 sites in 4 countries.
Trial summary
This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- PGL4001, progestin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 209 participants
- Where
- 23 sitesin 4 countries
- Study dates
- Jul 2010to Feb 2012
- 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 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subject is a pre-menopausal woman aged between 18 and 48 years inclusive.
- Subject with a Body Mass Index ≥18 and ≤40.
- Subject with myomatous uterus size < 16 weeks.
- Subject must have at least one uterine myoma of at least 3 cm diameter in size and no myoma larger than 10 cm diameter diagnosed by ultrasound.
- Subject complained of strong uterine bleeding.
- Subject is eligible for hysterectomy or myomectomy.
- Females of childbearing potential have to practice a non-hormonal method of contraception.
Who cannot join
- Subject has a history of or current uterus, cervix, ovarian or breast cancer.
- Subject has a history of endometrium hyperplasia or adenocarcinoma in a biopsy performed within the past 6 months or similar lesions in the screening biopsy.
- Subject has a known severe coagulation disorder.
- Subject has a history of treatment for myoma with a SPRM, including ulipristal acetate.
- Subject has abnormal hepatic function at study entry.
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
Poland9 sites
Prywatna Klinika Polozniczo-Ginekologiczna
Bialystok, 15-224
INVICTA Sp. Z o.o.
Gdansk, 80-895
Private Practice
Katowice, 40-724
Private Practice
Lodz, 90-602
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Klinika Ginekologii Onkologicznej i Ginekologii
Lublin, 20-081
Private Practice
Warsaw, 00-815
Private Practice
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
Spain9 sites
Institut Universitari Dexeus Departamento de Ginecología
Barcelona, 08028
Hospital Universitario Hebron, gynecology department
Barcelona, 08035
Hospital Clinic i provincial de Barcelona, gynecology department
Barcelona, 08036
Hospital General de Ciudad Real Gynecology
Ciudad Real, 13005
Hospital Universitario de Guadalajara Consultas de Ginecología (Planta 0)
Guadalajara, 19002
Clinica Ginecologica CEOGA, departamento de Ginecologia
Lugo, 27002
Private pratice
Madrid, 28009
Hospital universitario 12 de Octubre, departamento de ginecologia
Madrid, 28041
CHIP
Málaga, 29010
Belgium3 sites
Cliniques Universitaires Saint-Luc
Brussels, 1200
CHR de la citadelle
Liège, 4000
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, 5530
Austria2 sites
Medical University Graz, department of obstetrics and gynecology
Graz, 8047
Medical University Vienna, department of obstetrics and gynecology
Vienna, 1090
About this study
Official title: A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of 3-months Open-label Treatment With PGL4001, Followed by a Randomised, Double-blind Placebo Controlled Period of 10 Days Treatment With Progestin, in Subjects With Myomas and Heavy Uterine Bleeding.
This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.
Read the detailed description
PGL4001 will be administered daily to all subjects in an open-label manner with no control group. The three months open label treatment period will be followed by a ten day double blind treatment with progestin or matching placebo. Subjects will be randomly assigned to progestin or matching placebo arm with a 1:1 ratio.
- Conditions
- Uterine Fibroids
- Being tested
- PGL4001, placebo, PGL4001, progestin
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PGL4001, placeboDrug
Also called Ulipristal acetate
PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).
PGL4001, progestinDrug
Also called Ulipristal acetate
PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of progestin Norethisterone acetate 10mg once daily (oral tablets).
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets). Receives: Drug: PGL4001, placebo |
| B | Experimental | Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets). Receives: Drug: PGL4001, progestin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy endpoints
Investigate efficacy of PGL4001 on uterine bleeding (% of subjects in amenorrhea at end of PGL4001 treatment), myoma size (transvaginal ultrasound), pain (short Mc Gill questionnaire) and quality of life (specific UFS-QoL questionnaire and general EQ-5D questionnaire).
Measured: From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo.
Number and proportion of subjects experiencing open label treatment-emergent adverse events
Measured: From baseline to end of PGL4001 treatment (3months treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- PregLem SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156857
- Sponsor's protocol ID
- PGL09-026
- Acronym
- PEARLIII
- Status last verified
- Jun 2013
- First submitted
- 1 Jul 2010
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Donnez J, Vazquez F, Tomaszewski J, Nouri K, Bouchard P, Fauser BC, Barlow DH, Palacios S, Donnez O, Bestel E, Osterloh I, Loumaye E; PEARL III and PEARL III Extension Study Group. Long-term treatment of uterine fibroids with ulipristal acetate ☆. Fertil Steril. 2014 Jun;101(6):1565-73.e1-18. doi: 10.1016/j.fertnstert.2014.02.008. Epub 2014 Mar 12.
PubMed 24630081
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of 3-months Open-label Treatment With PGL4001, Followed by a Randomised, Double-blind Placebo Controlled Period of 10 Days Treatment With Progestin, in Subjects With Myomas and Heavy Uterine Bleeding.
- ClinicalTrials.gov ID
- NCT01156857
- Acronym / sponsor ID
- PEARLIII / PGL09-026
- Conditions
- Uterine Fibroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- PregLem SAIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 5 Jul 2010 (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 multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.
Detailed description
PGL4001 will be administered daily to all subjects in an open-label manner with no control group. The three months open label treatment period will be followed by a ten day double blind treatment with progestin or matching placebo. Subjects will be randomly assigned to progestin or matching placebo arm with a 1:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: PGL4001, placeboDrug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets). |
| B | Experimental | Drug: PGL4001, progestinDrug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets). |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject is a pre-menopausal woman aged between 18 and 48 years inclusive.
- Subject with a Body Mass Index ≥18 and ≤40.
- Subject with myomatous uterus size < 16 weeks.
- Subject must have at least one uterine myoma of at least 3 cm diameter in size and no myoma larger than 10 cm diameter diagnosed by ultrasound.
- Subject complained of strong uterine bleeding.
Key exclusion criteria (5 listed)
- Subject has a history of or current uterus, cervix, ovarian or breast cancer.
- Subject has a history of endometrium hyperplasia or adenocarcinoma in a biopsy performed within the past 6 months or similar lesions in the screening biopsy.
- Subject has a known severe coagulation disorder.
- Subject has a history of treatment for myoma with a SPRM, including ulipristal acetate.
- Subject has abnormal hepatic function at study entry.
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 |
|---|---|---|
| PGL4001, placeboAlso: Ulipristal acetatePGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets). | Drug | A |
| PGL4001, progestinAlso: Ulipristal acetatePGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of progestin Norethisterone acetate 10mg once daily (oral tablets). | Drug | B |
Primary outcome
Efficacy endpoints
Time frame: From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo.
Investigate efficacy of PGL4001 on uterine bleeding (% of subjects in amenorrhea at end of PGL4001 treatment), myoma size (transvaginal ultrasound), pain (short Mc Gill questionnaire) and quality of life (specific UFS-QoL questionnaire and general EQ-5D questionnaire).
Number and proportion of subjects experiencing open label treatment-emergent adverse events
Time frame: From baseline to end of PGL4001 treatment (3months treatment)
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 15 Jan 2016.
- Derived from this study: PubMed 24630081Donnez J, Vazquez F, Tomaszewski J, Nouri K, Bouchard P, Fauser BC, Barlow DH, Palacios S, Donnez O, Bestel E, Osterloh I, Loumaye E; PEARL III and PEARL III Extension Study Group. Long-term treatment of uterine fibroids with ulipristal acetate ☆. Fertil Steril. 2014 Jun;101(6):1565-73.e1-18. doi: 10.1016/j.fertnstert.2014.02.008. Epub 2014 Mar 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
23 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 PGL4001, progestin in people with Uterine Fibroids, run by PregLem SA at 23 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 7 inclusion and 5 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 15 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 23 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?
Efficacy endpoints (time frame: From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo.). 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?
On the ClinicalTrials.gov record for NCT01156857, 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 15 Jan 2016.