PGL2001 Proof of Concept Study in Symptomatic Endometriosis

Endometriosis Clinical Trial

— AMBER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631981
• Other study ID #: PGL11-007
• Status: Completed
• Phase: Phase 2
• First received: June 19, 2012
• Last updated: June 2, 2014
• Start date: June 2012
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: PregLem SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of PharmacyPoland: Ministry of HealthRomania: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: May 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• PGL2001 + Primolut-Nor 5
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 5
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.

Locations

Country	Name	City	State
Hungary	Semmelweis Egyetem II. Szülészeti és Nogyógyászati Klinika	Budapest
Hungary	Synexus Magyarország Kft.	Budapest
Hungary	Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum Szuleszeti es Nogyogyaszati Klinika	Debrecen
Hungary	Pécsi Tudományegyetem Klinikai Központ Szülészeti és Nogyógyászati Klinika	Pecs
Hungary	Szegedi Tudományegyetem Szent-Györgyi Albert Klinkai Központ Szülészeti és Nogyógyászati Klinika	Szeged
Poland	Medica Pro Familia Sp. z o.o. S.K.A. - Oddzial Katowie	Katowice
Poland	Klinka Ginekologii Operacyjnej, Instytut-Centrum Zdrowia Matki Polki	Lódz
Poland	Medeor Plus Szpital Wielospecjalistyczny	Lódz
Poland	Specjalistyczny Gabinet Ginekologiczno-Polozniczy	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	Centralny Szpital Kliniczny MSWiA, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej	Warszawa
Poland	NZOZ Lecznica Medea	Warszawa
Poland	Private practice	Warszawa
Romania	Euromedica Hospital SA	Baia Mare
Romania	Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL	Brasov
Romania	Centrul Medical Euromed SRL	Bucharest
Romania	Genesys Fertility Center SRL	Bucharest
Romania	Spitalul Clinic "Nicolae Malaxa"	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
PregLem SA

Countries where clinical trial is conducted

Hungary,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-menstrual pelvic pain.	Use of a Visual Analogue Scale (VAS).	Daily collection up to 16 weeks	No