Endometriosis Clinical Trial
Official title:
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.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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