PGL5001 Proof of Concept Study in Inflammatory Endometriosis

NCT ID: NCT01630252

Last Updated: 2014-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-10-31

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.

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part A2 - Active Treatment arm

PGL5001 for 8 weeks + one DMPA injection

Group Type: ACTIVE_COMPARATOR

PGL5001

Intervention Type: DRUG

PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection

Part A2 - Placebo Treatment arm

PGL5001 matching placebo for 8 weeks + one DMPA injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

PGL5001 matching placebo (twice a day) for 8 weeks + one unique DMPA 150 mg injection

Part B - Active treatment arm

PGL5001 for 20 weeks + two DMPA injections

Group Type: ACTIVE_COMPARATOR

PGL5001

Intervention Type: DRUG

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

Part B - Placebo Treatment arm

PGL5001 matching placebo for 20 weeks + two DMPA 150mg injections

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

PGL5001 matching placebo (twice a day) for 20 weeks + DMPA 150mg injection. Second DMPA injection between 85 to 89 days after first injection

Part A1 - Active Treatment arm

PGL5001 for 8 weeks + one unique DMPA 150 mg injection

Group Type: EXPERIMENTAL

PGL5001

Intervention Type: DRUG

PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection

Interventions

PGL5001

PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection

Intervention Type: DRUG

Placebo

PGL5001 matching placebo (twice a day) for 8 weeks + one unique DMPA 150 mg injection

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

PGL5001

PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

PregLem SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elke Bestel, MD

Role: STUDY_DIRECTOR

PregLem SA

Locations

Prywatna Klinika Połozniczo-Ginekologiczna Sp z o.o.

Bialystok, , Poland

Countries

Poland

Other Identifiers

PGL11-021

Identifier Type: -

Identifier Source: org_study_id