Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

What Was Tested

The trial (phase 2) is built around Leuprolide.

It had three arms (groups): one (experimental), one (experimental) and Lupron (active comparator).

Lupron Depot.

The registry classes the interventions as drug.

Who Took Part

10 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Surgical interventions for uterine fibroids (e.g., hysterectomy, myomectomy, or uterine arterial embolization) must not be planned or anticipated during the study. Subject must have the following uterine fibroid-associated symptom: history of excessive menstrual bleeding. Regular or steady menstrual cycle lasting from 24 to 36 days. Willing to comply with all study procedures including the endometrial biopsies and PK blood draws for all visits including follow-up visits.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: documented endometriosis or active pelvic inflammatory disease; history of alcohol and/or drug abuse; any history or diagnosis of gynecological cancer or cervical dysplasia.

How the Study Was Run

The set-up was randomized, parallel-group and single-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.

In this single-blind Leuprolide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2008-05 with completion listed for 2009-08.

It ran at 4 sites in United States (3) and Mexico (1).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: The Primary Outcome Measure is the PK Characteristics of [amount hidden] Proellex.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 10 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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