PGL2001 Proof of Concept Study in Symptomatic Endometriosis

A Phase II, Multicentre, Randomised, Two-Arm, Parallel Group, Double-Blind, Placebo Controlled Study of the Steroid Sulfatase Inhibitor PGL2001 With Concomitant Administration of NETA (Norethisterone Acetate) for the Treatment of Symptoms Related to Endometriosis

This is a Phase II, multicentre, randomised, two-arm, parallel group ,double-blind, placebo controlled, study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of the steroid sulfatase inhibitor PGL2001 with concomitant, continuous NETA administration for the treatment of pain symptoms suggestive of endometriosis. The target population will be women of reproductive age with symptoms suggestive of endometriosis.

Inclusion Criteria:

• Provide written informed consent prior to initiation of any study related procedures.
• Be a woman of reproductive age between 18 and 45 years inclusive.
• Present with clinical signs suggestive of endometriosis.
• Be suffering from non menstrual pelvic pain and dysmenorrhea suggestive of endometriosis for at least 3 months prior to screening visit.

Exclusion Criteria:

• Be pregnant or currently lactating.
• Have diseases or suspected diseases which may cause pelvic pain not due to endometriosis.
• Have had any surgical treatment for endometriosis within the last 12 months.
• Have documented significant adenomyosis.
• Have participated in another clinical trial within the 30 days prior to the screening visit.