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PGL4001 Versus Placebo in Uterine Myomas (PEARLI)

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: NCT00755755
Recruitment Status : Completed
First Posted : September 19, 2008
Results First Posted : November 16, 2012
Last Update Posted : December 13, 2012
Sponsor:
Information provided by (Responsible Party):
PregLem SA

Brief Summary:
This trial will assess the efficacy and safety of PGL4001 with concomitant iron administration versus placebo with concomitant iron administration, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

Condition or disease Intervention/treatment Phase
Uterine Myomas Drug: PGL4001 (ulipristal) and iron Drug: PGL4001 matching placebo and iron Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of PGL4001 (Ulipristal) Versus Placebo for Pre-Operative Treatment of Symptomatic Uterine Myomas
Study Start Date : October 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A (PGL4001 5mg)
PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
Drug: PGL4001 (ulipristal) and iron
tablets
Other Name: Ulipristal acetate

Experimental: B (PGL4001 10mg)
PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
Drug: PGL4001 (ulipristal) and iron
Tablets
Other Name: Ulipristal acetate

Placebo Comparator: C (placebo)
PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
Drug: PGL4001 matching placebo and iron
tablets
Other Name: Placebo of ulipristal




Primary Outcome Measures :
  1. Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13) [ Time Frame: Week 13 visit ]

    Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.

    Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.

    A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.

    Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.

    The week 13 PBAC score was calculated using the last 28 days of treatment.


  2. Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit) [ Time Frame: Week 13 ]
    Percent change in total fibroid volume from screening to end of treatment visit (Week 13 visit) assessed by MRI and read centrally by a radiologist who was unaware of the study-group assignments. The total fibroid volume was the sum of the individual fibroid volumes.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be a pre-menopausal woman between 18 and 50 years inclusive.
  • Have excessive uterine bleeding due to myoma.
  • Have a myoma-related anaemia.
  • Have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size.
  • Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
  • If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
  • Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.

Exclusion Criteria:

  • Has a history of or current uterine, cervical, ovarian or breast cancer.
  • Has a history of or current endometrium atypical hyperplasia.
  • Has a known severe coagulation disorder.
  • Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.
  • Has abnormal hepatic function at study entry.
  • Has a positive pregnancy test at baseline or 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755755


Locations
Show Show 38 study locations
Sponsors and Collaborators
PregLem SA
Investigators
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Study Director: Dr Elke Bestel PregLem SA
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: PregLem SA
ClinicalTrials.gov Identifier: NCT00755755    
Other Study ID Numbers: PGL07-021
First Posted: September 19, 2008    Key Record Dates
Results First Posted: November 16, 2012
Last Update Posted: December 13, 2012
Last Verified: December 2012
Additional relevant MeSH terms:
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Myoma
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Iron
Ulipristal acetate
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents