PGL2001 Proof of Concept Study in Symptomatic Endometriosis (AMBER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01631981
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : June 3, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: PGL2001 + Primolut-Nor 5 Drug: Placebo + Primolut-Nor 5 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Non-menstrual pelvic pain. [ Time Frame: Daily collection up to 16 weeks ]
    Use of a Visual Analogue Scale (VAS).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01631981

Synexus Magyarország Kft.
Budapest, Hungary, 1036
Semmelweis Egyetem II. Szülészeti és Nőgyógyászati Klinika
Budapest, Hungary, 1082
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
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
NZOZ Lecznica Medea
Warszawa, Poland, 01-826
Private practice
Warszawa, Poland, 02-201
Centralny Szpital Kliniczny MSWiA, Klinika Połoznictwa, Chorob Kobiecych i Ginekologii Onkologicznej
Warszawa, Poland, 02-507
Medeor Plus Szpital Wielospecjalistyczny
Łódź, Poland, 91-308
Klinka Ginekologii Operacyjnej, Instytut-Centrum Zdrowia Matki Polki
Łódź, Poland, 93-338
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
Centrul Medical Euromed SRL
Bucharest, Romania, 020762
Spitalul Clinic "Nicolae Malaxa"
Bucharest, Romania, 022441
Sponsors and Collaborators
PregLem SA

Responsible Party: PregLem SA Identifier: NCT01631981     History of Changes
Other Study ID Numbers: PGL11-007
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: June 3, 2014
Last Verified: June 2014

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