PGL2001 Proof of Concept Study in Symptomatic Endometriosis
NCT ID: NCT01631981
Last Updated: 2014-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
162 participants
INTERVENTIONAL
2012-06-30
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PGL2001
PGL2001 + NETA followed by NETA-only follow-up period
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
Placebo + NETA followed by NETA-only follow-up period
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
FEMALE
No
Sponsors
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PregLem SA
INDUSTRY
Responsible Party
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Locations
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Synexus Magyarország Kft.
Budapest, , Hungary
Semmelweis Egyetem II. Szülészeti és Nőgyógyászati Klinika
Budapest, , Hungary
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum Szuleszeti es Nogyogyaszati Klinika
Debrecen, , Hungary
Pécsi Tudományegyetem Klinikai Központ Szülészeti és Nőgyógyászati Klinika
Pécs, , Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinkai Központ Szülészeti és Nőgyógyászati Klinika
Szeged, , Hungary
Medica Pro Familia Sp. z o.o. S.K.A. - Oddział Katowie
Katowice, , Poland
Medeor Plus Szpital Wielospecjalistyczny
Lodz, , Poland
Klinka Ginekologii Operacyjnej, Instytut-Centrum Zdrowia Matki Polki
Lodz, , Poland
Specjalistyczny Gabinet Ginekologiczno-Położniczy
Lublin, , Poland
Klinika Endokrynologii I Nieplodnosci Rozrodu, Ginekologiczno Polozniczy Szpital UM
Poznan, , Poland
VitroLive Sp. Z o.o
Szczecin, , Poland
Lubelskie Centrum Diagnostyczne
Świdnik, , Poland
NZOZ Lecznica Medea
Warsaw, , Poland
Private practice
Warsaw, , Poland
Centralny Szpital Kliniczny MSWiA, Klinika Połoznictwa, Chorob Kobiecych i Ginekologii Onkologicznej
Warsaw, , Poland
Euromedica Hospital SA
Baia Mare, , Romania
Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
Brasov, , Romania
Genesys Fertility Center SRL
Bucharest, , Romania
Centrul Medical Euromed SRL
Bucharest, , Romania
Spitalul Clinic "Nicolae Malaxa"
Bucharest, , Romania
Countries
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Other Identifiers
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PGL11-007
Identifier Type: -
Identifier Source: org_study_id
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