PGL4001 Versus GnRH-agonist in Uterine Myomas

Status

Completed

Phase

Phase 3

Enrollment

301 participants (actual)

Sponsor

PregLem SA · Industry

Design

Randomized · Double masking

Countries

9 countries

Austria, Belgium, France, Germany, Israel, Italy, Netherlands, Poland, Spain

Start

Aug 2008

Primary completion

Jan 2010

Completion

Jun 2010

First posted

25 Aug 2008 (estimated)

Last update posted

17 Dec 2012 (estimated)

Conditions

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.

• Experimental

  A (PGL4001 5 mg)

  Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)

• Experimental

  B (PGL4001 10mg)

  Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)

• Active comparator

  C (GnRH-agonist)

  PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)

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

   Registry description

   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

   Registry description

   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

   Registry description

   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.