PGL5001 Proof of Concept Study in Inflammatory Endometriosis

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).