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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by:

PregLem SA

ClinicalTrials.gov Identifier:

NCT01252069

First received: November 30, 2010

Last updated: June 8, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 30, 2010
Last Updated Date	June 8, 2012
Start Date ^ICMJE	January 2011
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 14, 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 during three successive periods each ended by a drug free period until return of menses. ] [ Designated as safety issue: No ] Investigate sustained 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 Uterine Fibroid Symptom and Quality of Life [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 during three successive periods each ended by a drug free period until return of menses. ] [ Designated as safety issue: Yes ] Assess the overall safety of the on-off 3 months administration of PGL4001 for up to a total of four treatment cycles. Number and proportion of subjects experiencing treatment-emergent adverse events observed by physical examination,vital signs, ECG, transvaginal ultrasound and laboratory parameters. Exploratory endpoints [ Time Frame: From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo during three successive periods each ended by a drug free period until return of menses. ] [ Designated as safety issue: No ] Assessment of the strengh of the first menstrual bleed after each PGL4001 treament using the Pictorial Bleeding Assessment Chart (PBAC).
Original Primary Outcome Measures ^ICMJE (submitted: December 1, 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 during three successive periods each ended by a drug free period until return of menses. ] [ Designated as safety issue: No ] Investigate sustained 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 during three successive periods each ended by a drug free period until return of menses. ] [ Designated as safety issue: Yes ] Assess the overall safety of the on-off 3 months administration of PGL4001 for up to a total of four treatment cycles. Number and proportion of subjects experiencing treatment-emergent adverse events observed by physical examination,vital signs, ECG, transvaginal ultrasound and laboratory parameters. Exploratory endpoints [ Time Frame: From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo during three successive periods each ended by a drug free period until return of menses. ] [ Designated as safety issue: No ] Assessment of the strengh of the first menstrual bleed after each PGL4001 treament using the Pictorial Bleeding Assessment Chart (PBAC).
Change History	Complete list of historical versions of study NCT01252069 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)
Official Title ^ICMJE	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
Brief 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. 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Uterine Fibroids
Intervention ^ICMJE	Drug: PGL4001, placebo, drug free period 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. Other Name: Ulipristal acetate Drug: PGL4001, progestin, drug free period 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. Other Name: Ulipristal acetate
Study Arm (s)	Experimental: A 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. Intervention: Drug: PGL4001, placebo, drug free period Experimental: B 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. Intervention: Drug: PGL4001, progestin, drug free period
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	Active, not recruiting
Estimated Enrollment ^ICMJE	200
Estimated Completion Date	January 2014
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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. Exclusion Criteria: 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.
Gender	Female
Ages	18 Years to 48 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Austria, Belgium, Poland, Spain

Administrative Information
NCT Number ^ICMJE	NCT01252069
Other Study ID Numbers ^ICMJE	PGL09-027
Has Data Monitoring Committee	No
Responsible Party	Dr Elke Bestel, PregLem SA
Study Sponsor ^ICMJE	PregLem SA
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	PregLem SA
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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