PGL5001 Proof of Concept Study in Inflammatory Endometriosis

Summary

This is a prospective, three-part (Part A1, Part A2 and Part B),Phase II study investigating the efficacy, safety, pharmacokinetics and pharmacodynamics of the JNK inhibitor PGL5001 orally administered for up to 5 months with concomitant DMPA administration for the treatment of laparoscopically diagnosed inflammatory endometriosis. The part A1 is open-label, the parts A2 and B are double-blind. The target population will be women of reproductive age and suffering from newly diagnosed peritoneal and/or ovarian endometriosis.

Timeline

Start

2012-06

Primary completion

2013-09

Completion

2013-10

Drugs

Indications