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PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01156857
Recruitment Status : Completed
First Posted : July 5, 2010
Last Update Posted : January 15, 2016
Sponsor:
Information provided by (Responsible Party):
PregLem SA

Tracking Information
First Submitted Date  ICMJE July 1, 2010
First Posted Date  ICMJE July 5, 2010
Last Update Posted Date January 15, 2016
Study Start Date  ICMJE July 2010
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2016)
  • 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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2010)
  • 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).
  • Safety endpoints [ Time Frame: 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 treatment-emergent adverse events observed by physical examination, transvaginal ultrasound and blood samples.
  • Exploratory endpoints [ Time Frame: From baseline to end of PGL4001 treatment (3months treatment) ]
    Assessment of the strengh of the first menstraual bleed after PGL4001 treament using the Pictorial Bleeding Assessment Chart (PBAC).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
Official Title  ICMJE 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.
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Uterine Fibroids
Intervention  ICMJE
  • Drug: PGL4001, placebo
    PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).
    Other Name: Ulipristal acetate
  • Drug: PGL4001, progestin
    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).
    Other Name: Ulipristal acetate
Study Arms  ICMJE
  • Experimental: A
    Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).
    Intervention: Drug: PGL4001, placebo
  • Experimental: B
    Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets).
    Intervention: Drug: PGL4001, progestin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2013)
209
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2010)
200
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 48 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Poland,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01156857
Other Study ID Numbers  ICMJE PGL09-026
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party PregLem SA
Original Responsible Party Dr Elke Bestel, PregLem SA
Current Study Sponsor  ICMJE PregLem SA
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account PregLem SA
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP