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

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

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

PGL4001

leuprorelin

Dr Elke Bestel

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.

PGL4001 Versus GnRH-agonist in Uterine Myomas

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

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.

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

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.

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).

PregLem SA

A (PGL4001 5mg)

B (PGL4001 10mg)

C (GnRH-agonist)

Total

Age, Categorical

Age Continuous

Sex: Female, Male

Austria

Belgium

Germany

Spain

Israel

Italy

Poland

Region of Enrollment

As comparison involved two doses of PGL4001 vs GnRH-agonist, Bonferroni correction used to adjust confidence intervals.

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)

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

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

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

Overall Study

Spots Global Cancer Trial Database for pgl4001

Every month we try and update this database with for pgl4001 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pgl4001

Every month we try and update this database with for pgl4001 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pgl4001 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.