PGL2001 Proof of Concept Study in Symptomatic Endometriosis (AMBER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PregLem SA
ClinicalTrials.gov Identifier:
NCT01631981
First received: June 19, 2012
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Endometriosis
Drug: PGL2001 + Primolut-Nor 5
Drug: Placebo + Primolut-Nor 5
Phase 2

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

Resource links provided by NLM:


Further study details as provided by PregLem SA:

Primary Outcome Measures:
  • Non-menstrual pelvic pain. [ Time Frame: Daily collection up to 16 weeks ] [ Designated as safety issue: No ]
    Use of a Visual Analogue Scale (VAS).


Enrollment: 162
Study Start Date: June 2012
Study Completion Date: May 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PGL2001
PGL2001 + NETA followed by NETA-only follow-up period
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 Comparator: Placebo
Placebo + NETA followed by NETA-only follow-up period
Drug: 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.


  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631981

Locations
Hungary
Semmelweis Egyetem II. Szülészeti és Nőgyógyászati Klinika
Budapest, Hungary, 1082
Synexus Magyarország Kft.
Budapest, Hungary, 1036
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum Szuleszeti es Nogyogyaszati Klinika
Debrecen, Hungary, 4012
Pécsi Tudományegyetem Klinikai Központ Szülészeti és Nőgyógyászati Klinika
Pecs, Hungary, 7624
Szegedi Tudományegyetem Szent-Györgyi Albert Klinkai Központ Szülészeti és Nőgyógyászati Klinika
Szeged, Hungary, 6725
Poland
Medica Pro Familia Sp. z o.o. S.K.A. - Oddział Katowie
Katowice, Poland, 40-954
Specjalistyczny Gabinet Ginekologiczno-Położniczy
Lublin, Poland, 20-496
Klinika Endokrynologii I Nieplodnosci Rozrodu, Ginekologiczno Polozniczy Szpital UM
Poznan, Poland, 60-535
Lubelskie Centrum Diagnostyczne
Swidnik, Poland, 21040
VitroLive Sp. Z o.o
Szczecin, Poland, 71-074
Centralny Szpital Kliniczny MSWiA, Klinika Połoznictwa, Chorob Kobiecych i Ginekologii Onkologicznej
Warszawa, Poland, 02-507
NZOZ Lecznica Medea
Warszawa, Poland, 01-826
Private practice
Warszawa, Poland, 02-201
Klinka Ginekologii Operacyjnej, Instytut-Centrum Zdrowia Matki Polki
Łódź, Poland, 93-338
Medeor Plus Szpital Wielospecjalistyczny
Łódź, Poland, 91-308
Romania
Euromedica Hospital SA
Baia Mare, Romania, 430032
Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
Brasov, Romania, 500283
Genesys Fertility Center SRL
Bucharest, Romania, 011475
Spitalul Clinic "Nicolae Malaxa"
Bucharest, Romania, 022441
Centrul Medical Euromed SRL
Bucharest, Romania, 020762
Sponsors and Collaborators
PregLem SA
  More Information

No publications provided

Responsible Party: PregLem SA
ClinicalTrials.gov Identifier: NCT01631981     History of Changes
Other Study ID Numbers: PGL11-007
Study First Received: June 19, 2012
Last Updated: June 2, 2014
Health Authority: Hungary: National Institute of Pharmacy
Poland: Ministry of Health
Romania: Ministry of Public Health

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Norethindrone
Norethindrone acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014