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Uterine FibroidsPhase 3PEARLIVNCT01629563

PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

A Phase 3 study testing PGL4001 5 mg and PGL4001 10 mg in people with Uterine Fibroids, run by PregLem SA at 49 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Uterine Fibroids
What is being tested?
PGL4001 5 mg and PGL4001 10 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
451 participants
Where
49 sitesin 11 countries
Study dates
Jun 2012to Jan 2015
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 a Body Mass Index (BMI) ≥ 18 and ≤ 40.
  • Have FSH levels ≤ 20 mIU/mL
  • Have excessive uterine bleeding due to myoma.
  • Have regular menstrual cycles
  • Have a myomatous uterus < 16 weeks with at least one myoma ≥ 3 cm in diameter.
  • If of childbearing potential the subject must be practicing a non-hormonal method of contraception.

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).
  • Has abnormal hepatic function at study entry.
  • Has a positive pregnancy test, 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

49 sites in 11 countries.

49 sites in 11 countries

Czechia7 sites

  • Centrum ambulantni gynekologie a primarni pece

    Brno, 60200

  • FN Brno Gynekologicko - porodnická klinika

    Brno, 62500

  • Sanatorium SANUS

    Hradec Králové, 50002

  • Nemocnice Jihlava Gynekologicko - porodnicke oddeleni

    Jihlava, 58633

  • G-CENTRUM Olomouc s.r.o.

    Olomouc, 77200

  • FN Olomouc, Porodnicko-Gynekologicka klinika

    Olomouc, 77220

  • Femina Sana, s.r.o.

    Prague, 13000

Other trials in Czechia

Hungary7 sites

  • Rethy Pal Korhaz és Rendelointezet Szuleszeti es Nogyogyaszati Osztaly

    Békéscsaba, 5600

  • Institution Robert Karoly Maganklinika

    Budapest, 1135

  • Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Maganrendelo

    Debrecen, 4024

  • Josa Andras Oktatokorhaz

    Nyíregyháza, 4400

  • Fejer Megyei Szent Gyorgy Korhaz Szuleszeti es Nogyogyaszati Osztaly

    Székesfehérvár, 8000

  • Szuleszeti es Nogyogyaszati Osztaly

    Szentes, 6600

  • Sandor Dent Bt.

    Szolnok, 5000

Other trials in Hungary

Germany6 sites

  • Private practice

    Hamburg, 22159

  • Private practice

    Hamburg, 22359

  • Medizinische Hochschule Hannover Klinik für Frauenheilkunde und Geburtshilfe

    Hanover, 30625

  • Frauenarztpraxis

    Hessen, 60322

  • Praxis für Frauenheilkunde, Klinische Forschung und Weiterbildung

    Magdeburg, 39112

  • Technische Universität München

    München, 81675

Other trials in Germany

Romania6 sites

  • Centrul Medical SANA SRL

    Bucharest, 011025

  • Quantum Medical Center SRL Obstetrica-Ginecologie

    Bucharest, 011426

  • Fortis Medical Center SRL Obstetrica Ginecologie

    Bucharest, 012064

  • Spitalul Clinic Dr. I.Cantacuzino sectia Obstetrica-Ginecologie

    Bucharest, 020475

  • Centrul Medical EUROMED SRL, Departamentul de Obtetrica/Ginecologie

    Bucharest, 020762

  • Spitalul Clinic de Obstetrica

    Iași, 700398

Other trials in Romania

Belgium4 sites

  • Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique

    Brussels, 1200

  • UZ Leuven Campus Gasthuisberg

    Leuven, 3000

  • CHU de Liège, CHR de la Citadelle Gynécologie-Obstétrique

    Liège, 4000

  • CHU Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

Lithuania4 sites

  • Saules Family Medicine Center

    Kaunas, 49449

  • Family Medicine Centre"Seimos Gydytojas"

    Vilnius, 01118

  • Private Clinic "Maxmeda"

    Vilnius, 03225

  • Private Clinic "Kardiolita"

    Vilnius, 05263

Other trials in Lithuania

United Kingdom4 sites

  • MRC Centre for Reproductive Health University of Edinburgh

    Edinburgh, EH16 4TJ

  • North Middlesex University Hospital NHS Trust

    London, N18 1QX

  • Women's Health, Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • Norfolk & Norwich University Hospital

    Norwich, NR47UY

Other trials in United Kingdom

France3 sites

  • Hôpital Bicêtre - APHP

    Le Kremlin-Bicêtre, 94275

  • Hôpital Bichat, Service de Gynécologie Obstétrique

    Paris, 75018

  • CHU Bretonneau Service de Gynécologie Obstétrique

    Tours, 37044

Other trials in France

Latvia3 sites

  • Riga 1. hospital

    Riga, 1001

  • Latvian Medical Marine Center

    Riga, LV-1005

  • Medical Company "ARS"

    Riga, LV-1010

Other trials in Latvia

Ukraine3 sites

  • Kharkiv City Perinatal Center Gynaecological Department #1

    Kharkiv, 61176

  • Municipal Institution "Maternity Hospital #1" City Center of family planning

    Odesa, 65039

  • Maternity Hospital#4 Department of Gynaecology

    Zaporizhzhya, 69065

Other trials in Ukraine

Italy2 sites

  • Dipartimento di Ostetricia e Ginecologia, Università degli Studi di Catanzaro "Magna Graecia"

    Catanzaro, 88100

  • Policlinico Universitario "Agostino Gemelli"

    Roma, 00168

Other trials in Italy

About this study

Official title: A Phase III, Multicentre, Randomized, Double-blind Clinical Study, Investigating the Efficacy and Safety of Repeated 12-week Courses of Daily 5mg or 10mg Doses of PGL4001 for the Long-term Management of Symptomatic Uterine Fibroids

Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.

Read the detailed description

The target population is composed of pre-menopausal women with symptomatic uterine myoma(s) characterised by heavy bleeding.The main objective of this study is to assess the sustained efficacy and safety of long term on-off treatment with PGL4001 5 or 10mg doses on uterine bleeding, myoma size, pain and quality of life.

Being tested
PGL4001 5 mg, PGL4001 10 mg
Medical subject headings
Leiomyoma

What participants receive

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

  • PGL4001 5 mgDrug

    Also called Ulipristal Acetate, Esmya

    PGL4001 5 mg daily administration

  • PGL4001 10 mgDrug

    Also called Ulipristal Acetate

    PGL4001 10mg daily administration

Study groups in NCT01629563
Study groupRoleWhat they receive
Ulipristal acetate (PGL4001) 5mgExperimentalAll subjects will be asked to take a 150mg size tablet (PGL4001 5mg or matching placebo: placebo 5) orally daily for repeated periods 84 days. The first treatment course will start on the first 4 days of menstruation and will be orally administered, once daily (1 tablet of 150mg size), for 84 days. The following three treatment courses should be started in the first two days of a menstrual period.
Receives: Drug: PGL4001 5 mg
Ulipristal acetate (PGL4001) 10mgExperimentalAll subjects will be asked to take a 300mg size tablet (PGL4001 10mg or matching placebo: placebo 10 ) orally daily for repeated periods 84 days. The first treatment course will start on the first 4 days of menstruation and will be orally administered, once daily (1 tablet of 300mg size), for 84 days. The following three treatment courses should be started in the first two days of a menstrual period.
Receives: Drug: PGL4001 10 mg

What is being measured

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

  1. Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses

    Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval. Subjects need to be in amenorrhoea at the end of all four treatment courses, i.e for at least 4x35 days.

    Measured: 18 months study duration per subject (4 3-month intermittent treatment courses)

Secondary outcomes (6)

  1. Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4

    Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval.

    Measured: After 18 months

  2. Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses

    Controlled bleeding was defined as no episodes of heavy bleeding and a maximum of 8 days of bleeding during the last 56 days of a treatment course.

    Subjects need to be in controlled bleeding at the end of all 4 treatment courses i.e. for at least 4x56 days.

    Measured: After 18 months

  3. Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids

    For the 3 largest myomas at baseline and the 3 largest myomas at the end of treatment course 4 identified by transvaginal ultrasound, length, height and depth were measured and the volume was estimated by applying the equation for the voulme of an ellipsoid (length x height x depht x π/6).

    Subjects were exposed to 4 3-month intermittent courses.

    Measured: After 18 months

  4. Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL)

    Quality of Life was assessed using a validated questionnaire measuring uterine fibroid symptom severity (UFSQoL) where lower scores indicate fewer symtoms and where a level of 23 has been reported for healthy subject (scale 0-100).

    Subjects were exposed to 4 3-month intermittent courses.

    Measured: After 18 months

  5. Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life -Uterine Fibroid Health Related Quality of Life (HRQL)

    Quality of Life was measured using a validated uterine fibroid symptom questionnaire. Total score for health related quality of Life (HRQL) range from 0 to 100 with higher scores indicating better Quality of Life.

    Subjects were exposed to 4 3-month intermittent courses.

    Measured: 18 months

  6. Percentage of Change From Baseline to End of Treatment Course 4 in Pain Using a Visual Analogue Scale (VAS)

    Pain was assessed using a Visual Analogue Scale (VAS) ranging from 0 to 100 with higher score indicating more severe pain.

    Subjects were exposed to 4 3-month intermittent courses.

    Measured: After 18 months

Timeline

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

  1. First posted27 Jun 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionJan 2015
  4. Study completionJan 2015

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
451 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01629563
Sponsor's protocol ID
PGL11-006
Acronym
PEARLIV
Status last verified
Aug 2019
First submitted
19 Jun 2012
Last updated
4 Sep 2019
Data monitoring committee
Yes

Publications

  • Donnez J, Donnez O, Matule D, Ahrendt HJ, Hudecek R, Zatik J, Kasilovskiene Z, Dumitrascu MC, Fernandez H, Barlow DH, Bouchard P, Fauser BC, Bestel E, Loumaye E. Long-term medical management of uterine fibroids with ulipristal acetate. Fertil Steril. 2016 Jan;105(1):165-173.e4. doi: 10.1016/j.fertnstert.2015.09.032. Epub 2015 Oct 23.

    PubMed 26477496

  • Donnez J, Hudecek R, Donnez O, Matule D, Arhendt HJ, Zatik J, Kasilovskiene Z, Dumitrascu MC, Fernandez H, Barlow DH, Bouchard P, Fauser BC, Bestel E, Terrill P, Osterloh I, Loumaye E. Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids. Fertil Steril. 2015 Feb;103(2):519-27.e3. doi: 10.1016/j.fertnstert.2014.10.038. Epub 2014 Dec 24.

    PubMed 25542821

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PGL4001 5 mg and PGL4001 10 mg in people with Uterine Fibroids, run by PregLem SA at 49 sites in 11 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 8 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 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in Czechia, Hungary, Germany, Romania, Belgium and 6 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 4 Sep 2019). 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 Who Are in Amenorrhea at the End of All Four Treatment Courses (time frame: 18 months study duration per subject (4 3-month intermittent treatment courses)). 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 NCT01629563, which also lists 2 linked publications.

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 4 Sep 2019.

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