Uterine FibroidsPhase 3NCT01252069
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)
A Phase 3 study testing PGL4001, progestin, drug free period in people with Uterine Fibroids, run by PregLem SA at 18 sites in 4 countries.
Trial summary
This is the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets 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, drug free period
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 18 sitesin 4 countries
- Study dates
- Jan 2011to Jan 2014
- 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 completed visit 6 of PGL09-026 study, 10 to 18 days after menstruation following end of treatment with PGL4001, and did not take medications forbidden by the protocol.
Who cannot join
- Subject has a large uterine polyp (> 2cm).
- Subject has one or more ovarian cysts ≥ 4cm diagnosed by ultrasound during PGL09-026 study.
- Subject has abnormal hepatic function at re-test.
- Subject has clinically significant abnormal findings at visit A or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject's safety or interfere with study evaluations.
- Subject has a positive pregnancy test or is planning a pregnancy during the course of the study.
Trial locations and contacts
18 sites in 4 countries.
18 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
Spain5 sites
Hospital Universitario Hebron, gynecology department
Barcelona, 08035
Clinica Ginecologica CEOGA, departamento de Ginecologia
Lugo, 27002
Private Practice
Madrid, 28009
HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre Departamento de Ginecología
Madrid, 28041
CHIP (Complejo Hospitalario Integral Privado)
Málaga, 29010
Belgium3 sites
Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique
Brussels, 1200
CHR de la Citadelle Gynécologie-Obstétrique
Liège, 4000
Cliniques Universitaires UCL de Mont-Godinne Gynécologie-Obstétrique
Yvoir, 5530
Austria1 site
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 Three Successive Periods of 3-month Open-label PGL4001 Treatment, Each Followed by Ten Days of Double-blind Treatment With Progestin or Placebo and a Drug-free Period Until Return of Menses, in Subjects With Myomas and Heavy Uterine Bleeding
This is the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after end of PGL4001 treatment.
This extension study consists of three periods of 3 months open-label PGL4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and then a period without treatment.
- Conditions
- Uterine Fibroids
- Being tested
- PGL4001, placebo, drug free period, PGL4001, progestin, drug free period
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PGL4001, placebo, drug free periodDrug
Also called Ulipristal acetate
PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets) during 3 periods each ending with a drug free period until return of menses.
PGL4001, progestin, drug free periodDrug
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) during 3 periods each ending with a drug free period until return of menses.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets) during 3 periods each ended by a drug free period until return of menses. Receives: Drug: PGL4001, placebo, drug free period |
| B | Experimental | PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets) during 3 periods each ended by a drug free period until return of menses. Receives: Drug: PGL4001, progestin, drug free period |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received
Measured: From baseline to end of each 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 posted2 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionAug 2013
- Study completionJan 2014
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
- 132 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
- NCT01252069
- Sponsor's protocol ID
- PGL09-027
- Status last verified
- Jan 2016
- First submitted
- 30 Nov 2010
- Last updated
- 13 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 13 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 Three Successive Periods of 3-month Open-label PGL4001 Treatment, Each Followed by Ten Days of Double-blind Treatment With Progestin or Placebo and a Drug-free Period Until Return of Menses, in Subjects With Myomas and Heavy Uterine Bleeding
- ClinicalTrials.gov ID
- NCT01252069
- Acronym / sponsor ID
- PGL09-027
- Conditions
- Uterine Fibroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- PregLem SAIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 2 Dec 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 the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after end of PGL4001 treatment.
This extension study consists of three periods of 3 months open-label PGL4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and then a period without treatment.
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, placebo, drug free periodPGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets) during 3 periods each ended by a drug free period until return of menses. |
| B | Experimental | Drug: PGL4001, progestin, drug free periodPGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets) during 3 periods each ended by a drug free period until return of menses. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subject completed visit 6 of PGL09-026 study, 10 to 18 days after menstruation following end of treatment with PGL4001, and did not take medications forbidden by the protocol.
Key exclusion criteria (5 listed)
- Subject has a large uterine polyp (> 2cm).
- Subject has one or more ovarian cysts ≥ 4cm diagnosed by ultrasound during PGL09-026 study.
- Subject has abnormal hepatic function at re-test.
- Subject has clinically significant abnormal findings at visit A or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject's safety or interfere with study evaluations.
- Subject has a positive pregnancy test or is planning a pregnancy during the course of the study.
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, placebo, drug free periodAlso: Ulipristal acetatePGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets) during 3 periods each ending with a drug free period until return of menses. | Drug | A |
| PGL4001, progestin, drug free periodAlso: 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) during 3 periods each ending with a drug free period until return of menses. | Drug | B |
Primary outcome
percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received
Time frame: From baseline to end of each 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 13 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.
18 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, drug free period in people with Uterine Fibroids, run by PregLem SA at 18 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 1 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 13 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 18 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?
percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received (time frame: From baseline to end of each PGL4001 treatment (3months treatment)). 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 NCT01252069, 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 13 Jan 2016.