Study to Evaluate a Subcutaneous Four Months Sustained-release Formulation of Triptorelin in Patients With Prostate Cancer
NCT ID: NCT00415246
Last Updated: 2019-11-22
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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TERMINATED
PHASE3
100 participants
INTERVENTIONAL
2006-11-30
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study)
Eligibility Criteria
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Inclusion Criteria
* Patient must be 18 years old or over
* Patient must have a histologically-confirmed diagnosis of locally advanced or metastatic prostate cancer or presenting a relapse after curative treatment which is amenable to androgen deprivation therapy
* Patient must have an estimated survival time of greater than 8 months according to the investigator's assessment
Exclusion Criteria
* Patient who underwent a previous surgical castration
* Prostate cancer therapy within 2 months of baseline visit
* Patient with testosterone level below 150 ng/dL at screening
18 Years
MALE
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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ULB Erasme
Brussels, , Belgium
Academisch Ziekenhuis Vrije Universiteit Brussel
Brussels, , Belgium
UCL St Luc
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
UZ Gasthuisberg
Leuven, , Belgium
CHU Hôpital Gabriel Montpied
Clermont-Ferrand, , France
Hôpital Claude Huriez
Lille, , France
Hôpital Edouard Herriot
Lyon, , France
CHU Hôpital Salvator
Marseille, , France
Hôtel Dieu
Nantes, , France
Hôpital du Val de Grace
Paris, , France
Centre Hospitalier Saint Louis
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital Bichat
Paris, , France
CHU Hôpital de la Miletrie
Poitiers, , France
Hôpital Pontchaillou
Rennes, , France
CHU Rangueil
Toulouse, , France
Olega Hublarova arsta prakse urologija
Daugavpils, , Latvia
Latvijas Onkologijas centre
Riga, , Latvia
Paula Stradina Kliniska Universitates slimnica
Riga, , Latvia
Kauno Medicinos Universitteto Klinikos
Kaunas, , Lithuania
UAB 'Vilniaus onkourologijos-ginekologijos klinika
Vilnius, , Lithuania
Vilniaus universiteto
Vilnius, , Lithuania
Swietokrzyskie Centrum Onkologii
Kielce, , Poland
NZOZ Specjalista Sp, z.o.o.
Kutno, , Poland
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
Warsaw, , Poland
Akademicki Szpital Kliniczny
Wroclaw, , Poland
Hospital Gregorio Maranon
Madrid, , Spain
Ivano Frankovsk State Medical University
Ivano-Frankivsk, , Ukraine
Scientific Research Institute of Urology
Kiev, , Ukraine
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Countries
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Other Identifiers
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2006-001511-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2-55-52014-145
Identifier Type: -
Identifier Source: org_study_id
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