drugset / Trial / NCT01631981

PGL2001 Proof of Concept Study in Symptomatic Endometriosis

NCT01631981

Phase 2 Completed 162 enrolled PregLem SA
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase II, multicentre, randomised, two-arm, parallel group ,double-blind, placebo controlled, study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of the steroid sulfatase inhibitor PGL2001 with concomitant, continuous NETA administration for the treatment of pain symptoms suggestive of endometriosis. The target population will be women of reproductive age with symptoms suggestive of endometriosis.

Timeline

Start
2012-06
Primary completion
2013-10
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject E2MATE Small molecule 2 mg
Background Norethindrone Unknown 5 mg

Indications