NCT01631981

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2012

Geographic Reach
3 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 3, 2014

Status Verified

June 1, 2014

Enrollment Period

1.3 years

First QC Date

June 19, 2012

Last Update Submit

June 2, 2014

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

  • Non-menstrual pelvic pain.

    Use of a Visual Analogue Scale (VAS).

    Daily collection up to 16 weeks

Study Arms (2)

PGL2001

EXPERIMENTAL

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

Drug: PGL2001 + Primolut-Nor 5

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo + Primolut-Nor 5

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.

PGL2001
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.

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Synexus Magyarország Kft.

Budapest, 1036, Hungary

Location

Semmelweis Egyetem II. Szülészeti és Nőgyógyászati Klinika

Budapest, 1082, Hungary

Location

Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum Szuleszeti es Nogyogyaszati Klinika

Debrecen, 4012, Hungary

Location

Pécsi Tudományegyetem Klinikai Központ Szülészeti és Nőgyógyászati Klinika

Pécs, 7624, Hungary

Location

Szegedi Tudományegyetem Szent-Györgyi Albert Klinkai Központ Szülészeti és Nőgyógyászati Klinika

Szeged, 6725, Hungary

Location

Medica Pro Familia Sp. z o.o. S.K.A. - Oddział Katowie

Katowice, 40-954, Poland

Location

Medeor Plus Szpital Wielospecjalistyczny

Lodz, 91-308, Poland

Location

Klinka Ginekologii Operacyjnej, Instytut-Centrum Zdrowia Matki Polki

Lodz, 93-338, Poland

Location

Specjalistyczny Gabinet Ginekologiczno-Położniczy

Lublin, 20-496, Poland

Location

Klinika Endokrynologii I Nieplodnosci Rozrodu, Ginekologiczno Polozniczy Szpital UM

Poznan, 60-535, Poland

Location

VitroLive Sp. Z o.o

Szczecin, 71-074, Poland

Location

Lubelskie Centrum Diagnostyczne

Świdnik, 21040, Poland

Location

NZOZ Lecznica Medea

Warsaw, 01-826, Poland

Location

Private practice

Warsaw, 02-201, Poland

Location

Centralny Szpital Kliniczny MSWiA, Klinika Połoznictwa, Chorob Kobiecych i Ginekologii Onkologicznej

Warsaw, 02-507, Poland

Location

Euromedica Hospital SA

Baia Mare, 430032, Romania

Location

Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL

Brasov, 500283, Romania

Location

Genesys Fertility Center SRL

Bucharest, 011475, Romania

Location

Centrul Medical Euromed SRL

Bucharest, 020762, Romania

Location

Spitalul Clinic "Nicolae Malaxa"

Bucharest, 022441, Romania

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2012

First Posted

June 29, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2013

Study Completion

May 1, 2014

Last Updated

June 3, 2014

Record last verified: 2014-06

Locations

RO(5)PL(10)HU(5)