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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
PregLem SA
ClinicalTrials.gov Identifier:
NCT01629563
First received: June 19, 2012
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629563

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

No publications provided

Responsible Party: PregLem SA
ClinicalTrials.gov 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: L’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:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 19, 2013