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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection
PGL5001 matching placebo (twice a day) for 8 weeks + one unique DMPA 150 mg injection
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
Prywatna Klinika Połozniczo-Ginekologiczna Sp z o.o.
Bialystok, Poland
Change from baseline to end of treatment in the number and percentage of red lesions (and/or inflammatory lesions), based on total number of red and black lesions.
Time frame: at week 8, week 20
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
PGL5001 matching placebo (twice a day) for 20 weeks + DMPA 150mg injection. Second DMPA injection between 85 to 89 days after first injection
PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection