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

This study has been completed.
Information provided by (Responsible Party):
PregLem SA Identifier:
First received: June 19, 2012
Last updated: December 7, 2015
Last verified: December 2015
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 Intervention Phase
Uterine Fibroids. Drug: PGL4001 5 mg Drug: PGL4001 10 mg Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by PregLem SA:

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

Enrollment: 451
Study Start Date: June 2012
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01629563

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: PregLem SA Identifier: NCT01629563     History of Changes
Other Study ID Numbers: PGL11-006
Study First Received: June 19, 2012
Last Updated: December 7, 2015

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases processed this record on September 19, 2017