PGL2001 Proof of Concept Study in Symptomatic Endometriosis

Phase 2

Completed

• Conditions: Endometriosis
• Interventions: Drug: PGL2001 + Primolut-Nor 5; Drug: Placebo + Primolut-Nor 5

• Registration Number: NCT01631981
• Lead Sponsor: PregLem SA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-06-29
• Primary Completion: 2013-10
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-02
• Last Update Posted: 2014-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 162

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PGL2001	PGL2001 + Primolut-Nor 5	PGL2001 + NETA followed by NETA-only follow-up period
Placebo	Placebo + Primolut-Nor 5	Placebo + NETA followed by NETA-only follow-up period

Primary Outcome Measures

Name	Time	Method
Non-menstrual pelvic pain.	Daily collection up to 16 weeks	Use of a Visual Analogue Scale (VAS).

Trial Locations

Locations (20)

Synexus Magyarország Kft.; 🇭🇺 Budapest, Hungary

Semmelweis Egyetem II. Szülészeti és Nőgyógyászati Klinika; 🇭🇺 Budapest, Hungary

Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum Szuleszeti es Nogyogyaszati Klinika; 🇭🇺 Debrecen, Hungary

Pécsi Tudományegyetem Klinikai Központ Szülészeti és Nőgyógyászati Klinika; 🇭🇺 Pecs, Hungary

Szegedi Tudományegyetem Szent-Györgyi Albert Klinkai Központ Szülészeti és Nőgyógyászati Klinika; 🇭🇺 Szeged, Hungary

Medica Pro Familia Sp. z o.o. S.K.A. - Oddział Katowie; 🇵🇱 Katowice, Poland

Specjalistyczny Gabinet Ginekologiczno-Położniczy; 🇵🇱 Lublin, Poland

Klinika Endokrynologii I Nieplodnosci Rozrodu, Ginekologiczno Polozniczy Szpital UM; 🇵🇱 Poznan, Poland

Lubelskie Centrum Diagnostyczne; 🇵🇱 Swidnik, Poland

VitroLive Sp. Z o.o; 🇵🇱 Szczecin, Poland

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