PGL5001 Proof of Concept Study in Inflammatory Endometriosis

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PregLem SA
• Treatments: Medroxyprogesterone Acetate

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).