NCT01631981

PGL2001 Proof of Concept Study in Symptomatic Endometriosis

A Phase II, Multicentre, Randomised, Two-Arm, Parallel Group, Double-Blind, Placebo Controlled Study of the Steroid Sulfatase Inhibitor PGL2001 With Concomitant Administration of NETA (Norethisterone Acetate) for the Treatment of Symptoms Related to Endometriosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: PregLem SA · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	PGL2001 + Primolut-Nor 5	PGL2001(estradiol sulfamate, E2MATE, ZK190628), Tablets, 1mg. 4 mg weekly for 4 weeks followed by 2mg weekly for 12 weeks. Norethisterone acetate (NETA), Tablets, 5mg. Once daily for 16 weeks plus during follow-up.
DRUG	Placebo + Primolut-Nor 5	Placebo, Tablets.4 tablets weekly for 4 weeks followed by 2 tablets weekly for 12 weeks. Norethisterone acetate (NETA), Tablets, 5mg.Once daily for 16 weeks plus during follow-up.

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-10-01
• Completion: 2014-05-01
• First posted: 2012-06-29
• Last updated: 2014-06-03

Locations

20 sites across 3 countries: Hungary, Poland, Romania