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PGL4001 Versus GnRH-agonist in Uterine Myomas (PEARLII)

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: NCT00740831
Recruitment Status : Completed
First Posted : August 25, 2008
Results First Posted : November 16, 2012
Last Update Posted : December 17, 2012
Sponsor:
Information provided by (Responsible Party):
PregLem SA

Study Description
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Brief Summary:
This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, 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 Drug: leuprorelin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, Parallel Group, Double-blind, Double-dummy, Active Comparator-controlled, Multicenter Study to Assess the Efficacy and Safety of PGL4001 vs GnRH-agonist for Pre-operative Ttt of Symptomatic Uterine Myomas
Study Start Date : August 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Leuprorelin

Arms and Interventions
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Arm Intervention/treatment
Experimental: A (PGL4001 5 mg)
Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
 Drug: PGL4001
tablets
Other Name: Ulipristal acetate
Experimental: B (PGL4001 10mg)
Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
 Drug: PGL4001
tablets
Other Name: Ulipristal acetate
Active Comparator: C (GnRH-agonist)
PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
 Drug: leuprorelin
solution for injection
Other Name: GnRH-agonist


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit) [ Time Frame: 3 months ]

    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 Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist [ Time Frame: Week 13 visit ]
    Measured by log 10 (log pg/ml) transformed values for estradiol (E2) in blood samples

  3. Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist [ Time Frame: Up to week 17 ]

    Difference in percentage of subjects reporting moderate or severe hot flushes:

    Frequency and severity of this adverse event(as spontaneously reported by patients or elicited by nonleading questions) were recorded on standard forms at every visit up to week 17.



Secondary Outcome Measures :
  1. Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13 [ Time Frame: 3 months ]

    Assessment of PGL4001 capacity to decrease volume of the three largest myomas was performed at each center by means of ultrasonography at baseline and at week 13.

    The total volume of the three largest myomas assessed at screening and at end-of-treatment visit (Week 13) was analysed on a logarithm transformed scale (to base 10).



Eligibility Criteria
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Information from the National Library of Medicine

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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 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 or adenocarcinoma.
  • 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 a history of or known current osteoporosis.
  • 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.
Contacts and Locations
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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): NCT00740831


Locations
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Sponsors and Collaborators
PregLem SA
Investigators
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Study Director: Dr Elke Bestel PregLem SA
More Information
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Publications of Results:

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Responsible Party: PregLem SA
ClinicalTrials.gov Identifier: NCT00740831    
Other Study ID Numbers: PGL07-022
First Posted: August 25, 2008    Key Record Dates
Results First Posted: November 16, 2012
Last Update Posted: December 17, 2012
Last Verified: December 2012
Keywords provided by PregLem SA:
Uterine Myomas
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
Leuprolide
 Ulipristal acetate
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Female