NCT01630252

PGL5001 Proof of Concept Study in Inflammatory Endometriosis

A Phase IIa Efficacy and Safety Study of PGL5001 Versus Placebo Administered for up to 5 Months With Concomitant Administration of Depot Medroxyprogesterone Acetate for the Treatment of Peritoneal and/or Ovarian Endometriosis With an Inflammatory Component.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: PregLem SA · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	PGL5001	PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection
DRUG	Placebo	PGL5001 matching placebo (twice a day) for 8 weeks + one unique DMPA 150 mg injection
DRUG	PGL5001	PGL5001 320mg/day (160 mg twice a day) for 20 weeks + DMPA 150mg injection. Second DMPA injection between 85 to 89 days after first injection
DRUG	Placebo	PGL5001 matching placebo (twice a day) for 20 weeks + DMPA 150mg injection. Second DMPA injection between 85 to 89 days after first injection
DRUG	PGL5001	PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-09-01
• Completion: 2013-10-01
• First posted: 2012-06-28
• Last updated: 2014-06-03

Locations

1 site across 1 country: Poland