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

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ClinicalTrials.gov Identifier: NCT01629563
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : December 8, 2015
Sponsor:
Information provided by (Responsible Party):
PregLem SA

Brief Summary:
This is a Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma. The target population is composed of pre-menopausal women with symptomatic uterine myoma(s) characterised by heavy bleeding.The main objective of this study is to assess the sustained efficacy and safety of long term on-off treatment with PGL4001 5 or 10mg doses on uterine bleeding, myoma size, pain and quality of life.

Condition or disease Intervention/treatment Phase
Uterine Fibroids. Drug: PGL4001 5 mg Drug: PGL4001 10 mg Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 451 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multicentre, Randomized, Double-blind Clinical Study, Investigating the Efficacy and Safety of Repeated 12-week Courses of Daily 5mg or 10mg Doses of PGL4001 for the Long-term Management of Symptomatic Uterine Fibroids
Study Start Date : June 2012
Primary Completion Date : January 2015
Study Completion Date : January 2015

Arm Intervention/treatment
Experimental: Ulipristal acetate (PGL4001) 5mg Drug: PGL4001 5 mg
PGL4001 5 mg daily administration
Experimental: Ulipristal acetate (PGL4001) 10mg Drug: PGL4001 10 mg
PGL4001 10mg daily administration



Primary Outcome Measures :
  1. Percentage of subjects who are in amenorrhea at the end of all four treatment courses [ Time Frame: 18 months study duration per subject (4 3-month intermittent treatment courses) ]

Secondary Outcome Measures :
  1. Percentage of subjects with controlled bleeding [ Time Frame: After 18 months ]
  2. Change from baseline in myoma volume [ Time Frame: After 18 months ]
  3. Change from baseline in quality of life [ Time Frame: After 18 months ]
  4. Change from baseline in pain [ Time Frame: After 18 months ]
  5. percentage of subjects who were in amenorrhea at the end of treatment course 4 [ Time Frame: After 18 months ]


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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 a Body Mass Index (BMI) ≥ 18 and ≤ 40.
  • Have FSH levels ≤ 20 mIU/mL
  • Have excessive uterine bleeding due to myoma.
  • Have regular menstrual cycles
  • Have a myomatous uterus < 16 weeks with at least one myoma ≥ 3 cm in diameter.
  • If of childbearing potential the subject must be practicing a non-hormonal method of contraception.

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).
  • Has abnormal hepatic function at study entry.
  • Has a positive pregnancy test, 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): NCT01629563


  Show 49 Study Locations
Sponsors and Collaborators
PregLem SA
Investigators
Study Director: Elke Bestel, MD PregLem SA