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Completed

NCT Number: NCT01629563

PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

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.

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Key information

Conditions

Uterine Fibroids Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PGL4001 5 mg

Drug

PGL4001 5 mg daily administration

Other names: Ulipristal Acetate, Esmya

PGL4001 10 mg

Drug

PGL4001 10mg daily administration

Other names: Ulipristal Acetate

Primary outcomes

  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)

    Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval. Subjects need to be in amenorrhoea at the end of all four treatment courses, i.e for at least 4x35 days.

Secondary outcomes

  1. Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4

    Time frame: After 18 months

    Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval.

  2. Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses

    Time frame: After 18 months

    Controlled bleeding was defined as no episodes of heavy bleeding and a maximum of 8 days of bleeding during the last 56 days of a treatment course.

    Subjects need to be in controlled bleeding at the end of all 4 treatment courses i.e. for at least 4x56 days.

  3. Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids

    Time frame: After 18 months

    For the 3 largest myomas at baseline and the 3 largest myomas at the end of treatment course 4 identified by transvaginal ultrasound, length, height and depth were measured and the volume was estimated by applying the equation for the voulme of an ellipsoid (length x height x depht x π/6).

    Subjects were exposed to 4 3-month intermittent courses.

  4. Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL)

    Time frame: After 18 months

    Quality of Life was assessed using a validated questionnaire measuring uterine fibroid symptom severity (UFSQoL) where lower scores indicate fewer symtoms and where a level of 23 has been reported for healthy subject (scale 0-100).

    Subjects were exposed to 4 3-month intermittent courses.

  5. Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life -Uterine Fibroid Health Related Quality of Life (HRQL)

    Time frame: 18 months

    Quality of Life was measured using a validated uterine fibroid symptom questionnaire. Total score for health related quality of Life (HRQL) range from 0 to 100 with higher scores indicating better Quality of Life.

    Subjects were exposed to 4 3-month intermittent courses.

  6. Percentage of Change From Baseline to End of Treatment Course 4 in Pain Using a Visual Analogue Scale (VAS)

    Time frame: After 18 months

    Pain was assessed using a Visual Analogue Scale (VAS) ranging from 0 to 100 with higher score indicating more severe pain.

    Subjects were exposed to 4 3-month intermittent courses.

Sponsors and collaborators

Lead sponsor

PregLem SA

Industry

Registry information

Official study 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

Acronym: PEARLIV

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 27, 2012
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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