PGL4001 Versus GnRH-agonist in Uterine Myomas

What Was Tested

In this phase 3 trial, researchers set out to test Leuprolide.

It had three arms (groups): one (experimental), one (experimental) and C (GnRH-agonist) (active comparator).

The registry classes the interventions as drug.

Who Took Part

301 actual participants took part.

It was open to women only aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

The Leuprolide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Leuprolide.

Those kept unaware of assignments: participant and investigator.

It started in 2008-08 with completion listed for 2010-01.

It ran at 46 sites in Spain (9), Germany (8), Italy (7), Israel (6), Poland (5) and Austria (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 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). 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).

It also tracked 1 secondary outcome, for example Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 301 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Leuprolide compound page, all human trials.