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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
PregLem SA Identifier:
First received: June 19, 2012
Last updated: January 7, 2013
Last verified: January 2013

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 treatment. [ Time Frame: After 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects with controlled bleeding [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
  • Proportion of days with heavy bleeding [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
  • Change from baseline in myoma volume [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
  • Change from baseline in quality of life [ Time Frame: After 18 months ] [ Designated as safety issue: No ]
  • Change from baseline in pain [ Time Frame: After 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 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
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: PregLem SA Identifier: NCT01629563     History of Changes
Other Study ID Numbers: PGL11-006
Study First Received: June 19, 2012
Last Updated: January 7, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Ministry of Health
Romania: Ministry of Public Health
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Connective Tissue Diseases
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue processed this record on November 24, 2014