PGL5001 Proof of Concept Study in Inflammatory Endometriosis

Phase 2

Completed

• Conditions: Endometriosis
• Interventions: Drug: PGL5001; Drug: Placebo

• Registration Number: NCT01630252
• Lead Sponsor: PregLem SA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-28
• Primary Completion: 2013-09
• Study Completion: 2013-10
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-02
• Last Update Posted: 2014-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• The Subject must provide written informed consent prior to initiation of any study related procedures.
• The Subject must be an adult woman of reproductive age, aged from 18 and above.
• The Subject must be a newly diagnosed patient suffering from peritoneal and/or ovarian endometriosis with at least 15% of the endometriotic lesions observed at the study diagnostic laparoscopy being red inflammatory lesions and with a proven histological diagnosis.
• The Subject must consent to the scheduling of a second laparoscopy for surgical treatment at the study end.
• The Subject must have a history of pelvic pain for at least 3 months prior to the screening visit.

Exclusion Criteria

• The Subject is over 40 years old and has a FSH serum level during Day 2-4 of her cycle ≥ 21.5 mIU/ml.
• The Subject has a positive pregnancy test at baseline or is breast-feeding or planning a pregnancy during the course of the study.
• The Subject is known for having a cause of chronic abdominal/pelvic pain other than endometriosis (e.g. inflammatory bowel disease, fibromyalgia, interstitial cystitis).
• The Subject has a history of surgical treatment for endometriosis prior to the study diagnostic laparoscopy.
• The Subject is requiring urgent surgical excision of endometriotic lesions at the time of first diagnostic laparoscopy.
• The Subject has a history (in the past 12 months) of or a current medical treatment for endometriosis other than NSAID (e.g. GnRH agonist or antagonist, danazol, continuous oral combined oestroprogestogens).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A2 - Active Treatment arm	PGL5001	PGL5001 for 8 weeks + one DMPA injection
Part A2 - Placebo Treatment arm	Placebo	PGL5001 matching placebo for 8 weeks + one DMPA injection
Part B - Active treatment arm	PGL5001	PGL5001 for 20 weeks + two DMPA injections
Part B - Placebo Treatment arm	Placebo	PGL5001 matching placebo for 20 weeks + two DMPA 150mg injections
Part A1 - Active Treatment arm	PGL5001	PGL5001 for 8 weeks + one unique DMPA 150 mg injection

Primary Outcome Measures

Name	Time	Method
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.	at week 8, week 20

Trial Locations

Locations (1)

Prywatna Klinika Połozniczo-Ginekologiczna Sp z o.o.; 🇵🇱 Bialystok, Poland