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PGL2001 Proof of Concept Study in Symptomatic Endometriosis (AMBER)

Primary Purpose

Endometriosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PGL2001 + Primolut-Nor 5
Placebo + Primolut-Nor 5
Sponsored by
PregLem SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Synexus Magyarország Kft.
  • Semmelweis Egyetem II. Szülészeti és Nőgyógyászati Klinika
  • Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum Szuleszeti es Nogyogyaszati Klinika
  • Pécsi Tudományegyetem Klinikai Központ Szülészeti és Nőgyógyászati Klinika
  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinkai Központ Szülészeti és Nőgyógyászati Klinika
  • Medica Pro Familia Sp. z o.o. S.K.A. - Oddział Katowie
  • Specjalistyczny Gabinet Ginekologiczno-Położniczy
  • Klinika Endokrynologii I Nieplodnosci Rozrodu, Ginekologiczno Polozniczy Szpital UM
  • Lubelskie Centrum Diagnostyczne
  • VitroLive Sp. Z o.o
  • NZOZ Lecznica Medea
  • Private practice
  • Centralny Szpital Kliniczny MSWiA, Klinika Połoznictwa, Chorob Kobiecych i Ginekologii Onkologicznej
  • Medeor Plus Szpital Wielospecjalistyczny
  • Klinka Ginekologii Operacyjnej, Instytut-Centrum Zdrowia Matki Polki
  • Euromedica Hospital SA
  • Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
  • Genesys Fertility Center SRL
  • Centrul Medical Euromed SRL
  • Spitalul Clinic "Nicolae Malaxa"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PGL2001

Placebo

Arm Description

PGL2001 + NETA followed by NETA-only follow-up period

Placebo + NETA followed by NETA-only follow-up period

Outcomes

Primary Outcome Measures

Non-menstrual pelvic pain.
Use of a Visual Analogue Scale (VAS).

Secondary Outcome Measures

Full Information

First Posted
June 19, 2012
Last Updated
June 2, 2014
Sponsor
PregLem SA
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1. Study Identification

Unique Protocol Identification Number
NCT01631981
Brief Title
PGL2001 Proof of Concept Study in Symptomatic Endometriosis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PregLem SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PGL2001
Arm Type
Experimental
Arm Description
PGL2001 + NETA followed by NETA-only follow-up period
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo + NETA followed by NETA-only follow-up period
Intervention Type
Drug
Intervention Name(s)
PGL2001 + Primolut-Nor 5
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo + Primolut-Nor 5
Intervention Description
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.
Primary Outcome Measure Information:
Title
Non-menstrual pelvic pain.
Description
Use of a Visual Analogue Scale (VAS).
Time Frame
Daily collection up to 16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Synexus Magyarország Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Semmelweis Egyetem II. Szülészeti és Nőgyógyászati Klinika
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Facility Name
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum Szuleszeti es Nogyogyaszati Klinika
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Pécsi Tudományegyetem Klinikai Központ Szülészeti és Nőgyógyászati Klinika
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Szegedi Tudományegyetem Szent-Györgyi Albert Klinkai Központ Szülészeti és Nőgyógyászati Klinika
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Medica Pro Familia Sp. z o.o. S.K.A. - Oddział Katowie
City
Katowice
ZIP/Postal Code
40-954
Country
Poland
Facility Name
Specjalistyczny Gabinet Ginekologiczno-Położniczy
City
Lublin
ZIP/Postal Code
20-496
Country
Poland
Facility Name
Klinika Endokrynologii I Nieplodnosci Rozrodu, Ginekologiczno Polozniczy Szpital UM
City
Poznan
ZIP/Postal Code
60-535
Country
Poland
Facility Name
Lubelskie Centrum Diagnostyczne
City
Swidnik
ZIP/Postal Code
21040
Country
Poland
Facility Name
VitroLive Sp. Z o.o
City
Szczecin
ZIP/Postal Code
71-074
Country
Poland
Facility Name
NZOZ Lecznica Medea
City
Warszawa
ZIP/Postal Code
01-826
Country
Poland
Facility Name
Private practice
City
Warszawa
ZIP/Postal Code
02-201
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA, Klinika Połoznictwa, Chorob Kobiecych i Ginekologii Onkologicznej
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Medeor Plus Szpital Wielospecjalistyczny
City
Łódź
ZIP/Postal Code
91-308
Country
Poland
Facility Name
Klinka Ginekologii Operacyjnej, Instytut-Centrum Zdrowia Matki Polki
City
Łódź
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Euromedica Hospital SA
City
Baia Mare
ZIP/Postal Code
430032
Country
Romania
Facility Name
Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
Genesys Fertility Center SRL
City
Bucharest
ZIP/Postal Code
011475
Country
Romania
Facility Name
Centrul Medical Euromed SRL
City
Bucharest
ZIP/Postal Code
020762
Country
Romania
Facility Name
Spitalul Clinic "Nicolae Malaxa"
City
Bucharest
ZIP/Postal Code
022441
Country
Romania

12. IPD Sharing Statement

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PGL2001 Proof of Concept Study in Symptomatic Endometriosis

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