PGL2001 Proof of Concept Study in Symptomatic Endometriosis

Phase 2CompletedNCT01631981

PregLem SA162 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

162

Conditions

Endometriosis

Interventions

PGL2001 + Primolut-Nor 5DRUG

PGL2001(estradiol sulfamate, E2MATE, ZK190628), Tablets, 1mg. 4 mg weekly for 4 weeks followed by 2mg weekly for 12 weeks. Norethisterone acetate (NETA), Tablets, 5mg. Once daily for 16 weeks plus during follow-up.

Placebo + Primolut-Nor 5DRUG

Placebo, Tablets.4 tablets weekly for 4 weeks followed by 2 tablets weekly for 12 weeks. Norethisterone acetate (NETA), Tablets, 5mg.Once daily for 16 weeks plus during follow-up.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (20)

Synexus Magyarország Kft.

Budapest, Hungary

Outcomes

Primary Outcomes

Non-menstrual pelvic pain.

Use of a Visual Analogue Scale (VAS).

Time frame: Daily collection up to 16 weeks

Data from ClinicalTrials.gov

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