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Completed

NCT Number: NCT00740831

PGL4001 Versus GnRH-agonist in Uterine Myomas

This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

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Key information

Conditions

Uterine Myomas

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Medical University Graz, Graz, Austria

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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 excessive uterine bleeding due to myoma
  • Have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size
  • Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
  • If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
  • Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.

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) or a GnRH-agonist.
  • Has a history of or known current osteoporosis.
  • Has abnormal hepatic function at study entry.
  • Has a positive pregnancy test at baseline or 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

Drug

tablets

Other names: Ulipristal acetate

leuprorelin

Drug

solution for injection

Other names: GnRH-agonist

Primary outcomes

  1. Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit)

    Time frame: 3 months

    Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.

    Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.

    A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.

    Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.

    The week 13 PBAC score was calculated using the last 28 days of treatment.

  2. Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist

    Time frame: Week 13 visit

    Measured by log 10 (log pg/ml) transformed values for estradiol (E2) in blood samples

  3. Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist

    Time frame: Up to week 17

    Difference in percentage of subjects reporting moderate or severe hot flushes:

    Frequency and severity of this adverse event(as spontaneously reported by patients or elicited by nonleading questions) were recorded on standard forms at every visit up to week 17.

Secondary outcomes

  1. Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13

    Time frame: 3 months

    Assessment of PGL4001 capacity to decrease volume of the three largest myomas was performed at each center by means of ultrasonography at baseline and at week 13.

    The total volume of the three largest myomas assessed at screening and at end-of-treatment visit (Week 13) was analysed on a logarithm transformed scale (to base 10).

Sponsors and collaborators

Lead sponsor

PregLem SA

Industry

Registry information

Official study title

A Phase III, Randomised, Parallel Group, Double-blind, Double-dummy, Active Comparator-controlled, Multicenter Study to Assess the Efficacy and Safety of PGL4001 vs GnRH-agonist for Pre-operative Ttt of Symptomatic Uterine Myomas

Acronym: PEARLII

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 25, 2008
Registry last updated
Dec 17, 2012

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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