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PGL5001 Proof of Concept Study in Inflammatory Endometriosis

NCT01630252 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-06-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • PregLem SA

    lead INDUSTRY

Principal Investigators

  • Elke Bestel, MD · PregLem SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-09-30
Completion
2013-10-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01630252 on ClinicalTrials.gov