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Completed

NCT Number: NCT01156857

PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.

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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–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Medical University Graz, department of obstetrics and gynecology, Graz, Austria

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About this study

PGL4001 will be administered daily to all subjects in an open-label manner with no control group. The three months open label treatment period will be followed by a ten day double blind treatment with progestin or matching placebo. Subjects will be randomly assigned to progestin or matching placebo arm with a 1:1 ratio.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is a pre-menopausal woman aged between 18 and 48 years inclusive.
  • Subject with a Body Mass Index ≥18 and ≤40.
  • Subject with myomatous uterus size < 16 weeks.
  • Subject must have at least one uterine myoma of at least 3 cm diameter in size and no myoma larger than 10 cm diameter diagnosed by ultrasound.
  • Subject complained of strong uterine bleeding.
  • Subject is eligible for hysterectomy or myomectomy.
  • Females of childbearing potential have to practice a non-hormonal method of contraception.

Exclusion criteria

  • Subject has a history of or current uterus, cervix, ovarian or breast cancer.
  • Subject has a history of endometrium hyperplasia or adenocarcinoma in a biopsy performed within the past 6 months or similar lesions in the screening biopsy.
  • Subject has a known severe coagulation disorder.
  • Subject has a history of treatment for myoma with a SPRM, including ulipristal acetate.
  • Subject has abnormal hepatic function at study entry.

Treatment and study plan

PGL4001, placebo

Drug

PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).

Other names: Ulipristal acetate

PGL4001, progestin

Drug

PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of progestin Norethisterone acetate 10mg once daily (oral tablets).

Other names: Ulipristal acetate

Primary outcomes

  1. Efficacy endpoints

    Time frame: From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo.

    Investigate efficacy of PGL4001 on uterine bleeding (% of subjects in amenorrhea at end of PGL4001 treatment), myoma size (transvaginal ultrasound), pain (short Mc Gill questionnaire) and quality of life (specific UFS-QoL questionnaire and general EQ-5D questionnaire).

  2. Number and proportion of subjects experiencing open label treatment-emergent adverse events

    Time frame: From baseline to end of PGL4001 treatment (3months treatment)

Sponsors and collaborators

Lead sponsor

PregLem SA

Industry

Registry information

Official study title

A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of 3-months Open-label Treatment With PGL4001, Followed by a Randomised, Double-blind Placebo Controlled Period of 10 Days Treatment With Progestin, in Subjects With Myomas and Heavy Uterine Bleeding.

Acronym: PEARLIII

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jul 5, 2010
Registry last updated
Jan 15, 2016

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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