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PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLext2)

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: NCT01642472
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
PregLem SA

Tracking Information
First Submitted Date  ICMJE July 10, 2012
First Posted Date  ICMJE July 17, 2012
Last Update Posted Date January 8, 2016
Study Start Date  ICMJE July 2012
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2016)
  • Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire [ Time Frame: 9 months ]
    Average score of the first 3 questions.
  • Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire [ Time Frame: 18 months ]
    Average score of the first 3 questions.
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2012)
Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire [ Time Frame: After 18 months. ]
Average score of the first 3 questions.
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, Extension Study Investigating the Efficacy and Safety of Repeated Intermittent 3-month Courses of Open-label Administration of Ulipristal Acetate, in Subjects With Symptomatic Uterine Myomas and Heavy Uterine Bleeding
Brief Summary

This is a phase III, multicentre, long-term open-label extension of the phase III study: Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III extension (PGL09-027), patients have been exposed to a total of 4 cycles of daily 3month open-label treatment with ulipristal acetate 10mg before entering the proposed study Pearl extension 2 (PGL11-024).

This proposed study consists of 4 further consecutive courses of 3 months (84 days) open label ulipristal acetate 10mg once daily treatment each separated by a drug free period.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Uterine Fibroids
Intervention  ICMJE Drug: Ulipristal Acetate - open label
Ulipristal Acetate (PGL4001) tablets 10mg orally daily for 3 months (84 days) for each treatment course. There are four 3-month treatment courses in this study.
Other Name: PGL4001
Study Arms  ICMJE Experimental: Ulipristal Acetate (PGL4001) 10mg
Ulipristal Acetate (PGL4001)10mg daily administration
Intervention: Drug: Ulipristal Acetate - open label
Publications * Not Provided

*   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: January 7, 2016)
64
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2012)
90
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject completed visit F - Follow-up of Pearl III extension study (PGL09-027) - without significant deviations.
  • Females of childbearing potential are advised to practice a non-hormonal method of contraception.

Exclusion Criteria:

  • Subject has a history of uterus surgery (e.g. hysterectomy, myomectomy) or uterine artery embolization in Pearl III extension (PGL09-027) or afterwards that would interfere with the study assessments.
  • Subject has taken or is likely to require treatment during the study with drugs that are not permitted by the study protocol.
  • Subject is lactating, has a positive pregnancy test at study start or is planning a pregnancy during the course of the study.
  • Subject has abnormal baseline findings, any other medical condition(s) or laboratory finding that, in the opinion of the investigator, might jeopardise the subject's safety or interfere with study evaluations.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older 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 NCT01642472
Other Study ID Numbers  ICMJE PGL11-024
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PregLem SA
Study Sponsor  ICMJE PregLem SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Elke Bestel, Dr PregLem SA
PRS Account PregLem SA
Verification Date December 2015

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