PGL2001 Proof of Concept Study in Symptomatic Endometriosis (AMBER)

PregLem

Status and phase

Completed

Phase 2

Conditions

Endometriosis

Treatments

Drug: Placebo + Primolut-Nor 5

Drug: PGL2001 + Primolut-Nor 5

Study type

Interventional

Funder types

Industry

Identifiers

NCT01631981

PGL11-007

Details and patient eligibility

About

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.

Enrollment

162 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.