An Observational Study of Men With Premature Ejaculation Who Are Treated With Dapoxetine Hydrochloride or Alternate Care Defined as Any Treatment Other Than Dapoxetine Hydrochloride
A Prospective, Observational Study of Men With Premature Ejaculation Who Are Treated With PRILIGY or Alternate Care
3 other identifiers
observational
10,027
6 countries
212
Brief Summary
The purpose of the study is to collect information regarding the safety of dapoxetine hydrochloride when used in clinical practice to treat men with premature ejaculation. Dapoxetine hydrochloride is a selective inhibitor of serotonin reuptake that is indicated for the treatment of patients with premature ejaculation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2009
Typical duration for all trials
212 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 25, 2009
CompletedFirst Posted
Study publicly available on registry
November 30, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedNovember 26, 2013
November 1, 2013
November 25, 2009
November 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome measure is safety. Safety will be assessed by monitoring the occurrence of adverse events and the use of concomitant medications or therapies during the study.
Safety will be assessed at Visit 1 through 4 during the 12 week observation period and up to approximately 4 weeks after the End-of-Observation/Early Withdrawal Visit.
Study Arms (2)
001
Dapoxetine hydrochloride One 30 mg tablet up to a maximum of one 60 mg tablet approximately 1 to 3 hours prior to prior to sexual activity once every 24 hours as needed for 12 weeks
002
Alternate care/non-dapoxetine hydrochloride treatment(s) As prescribed or directed
Interventions
One 30 mg tablet up to a maximum of one 60 mg tablet approximately 1 to 3 hours prior to prior to sexual activity once every 24 hours as needed for 12 weeks
Eligibility Criteria
Men diagnosed with premature ejaculation will be enrolled in the study by participating health care providers in clinical practice settings.
You may qualify if:
- In accordance with the therapeutic indication stated in the Summary of Product Characteristics for dapoxetine hydrochloride, patients will be candidates for enrollment if they have an intravaginal ejaculatory latency time of less than two minutes
- Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes
- Marked personal distress or interpersonal difficulty as a consequence of premature ejaculation
- Poor control over ejaculation
You may not qualify if:
- In accordance with the contraindications, special warnings and precautions for use as stated in the Summary of Product Characteristics for dapoxetine hydrochloride, patients will be excluded from treatment if they have hypersensitivity to dapoxetine hydrochloride or to any of the excipients
- Significant pathological cardiac conditions such as: heart failure (New York Heart Association \[NYHA\] class II-IV), conduction abnormalities (second or third degree atrioventicular (AV) block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease, or significant valvular disease
- Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing treatment with an MAOI
- Concomitant treatment with thioridazine, concomitant treatment with serotonin reuptake inhibitors (selective serotonin reuptake inhibitors \[SSRIs\], serotonin-norepinephrine reuptake inhibitors \[SNRIs\], tricyclic antidepressants \[TCAs)\] or other medicinal/herbal products with serotonergic effects (for example, L-tryptophan, triptans, tramadol, linezolid, lithium, St. John's Wort (Hypericum perforatum)
- Concomitant treatment of potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazadone, nelfinavir, atazanavir, etc.
- Moderate and severe hepatic impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (212)
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Karpfenberg, Austria
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Reutte, Austria
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Vienna, Austria
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Helsinki, Finland
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Kouvola, Finland
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Mikkeli, Finland
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Oulu, Finland
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Turku, Finland
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Ahlen, Germany
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Ahrensburg, Germany
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Apolda, Germany
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Bad Doberan, Germany
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Bad Schönborn, Germany
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Bamberg, Germany
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Bautzen, Germany
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Berlin, Germany
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Bonn, Germany
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Böblingen, Germany
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Braunschweig, Germany
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Bremen, Germany
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Bruchsal, Germany
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Castrop-Rauxel, Germany
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Celle, Germany
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Chemnitz, Germany
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Cologne, Germany
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Dachau, Germany
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Dessau, Germany
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Dorsten, Germany
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Dortmund, Germany
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Dossenheim, Germany
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Dresden, Germany
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Duisburg, Germany
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Düren, Germany
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Düsseldorf, Germany
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Eisenberg, Germany
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Eisleben Lutherstadt, Germany
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Erfurt, Germany
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Erlangen, Germany
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Essen, Germany
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Frankfurt, Germany
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Garmisch-Partenkirchen, Germany
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Gotha, Germany
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Göppingen, Germany
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Grimma, Germany
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Grünstadt, Germany
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Hagenow, Germany
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Halle, Germany
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Hamburg, Germany
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Hanover, Germany
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Heidelberg, Germany
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Heilbronn, Germany
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Hemmoor, Germany
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Herford, Germany
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Herten, Germany
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Herzogenaurach, Germany
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Höchberg, Germany
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Höchheim, Germany
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Jena, Germany
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Kaiserslautern, Germany
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Karlsruhe, Germany
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Kempten, Germany
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Kiel, Germany
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Kirchheim, Germany
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Kleinmachnow, Germany
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Krefeld, Germany
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Kronach, Germany
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Lampertheim, Germany
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Landsberg, Germany
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Leipzig, Germany
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Leverkusen, Germany
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Lichtenfels, Germany
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Lüdinghausen, Germany
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Magdeburg, Germany
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Markkleeberg, Germany
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Mülheim, Germany
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München, Germany
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Münster, Germany
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Neckargemünd, Germany
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Neu-Ulm, Germany
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Neumünster, Germany
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Neuss, Germany
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Nordhausen, Germany
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Nuremberg, Germany
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Oberursel, Germany
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Oranienburg, Germany
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Osnabrück, Germany
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Ostfildern, Germany
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Peine, Germany
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Planegg, Germany
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Plauen, Germany
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Radebeul, Germany
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Rastatt, Germany
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Remscheid, Germany
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Reutlingen, Germany
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Rinteln, Germany
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Rostock, Germany
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Rottenberg, Germany
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Rottweil, Germany
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Sangerhausen, Germany
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Schleswig, Germany
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Schriesheim, Germany
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Schwerin, Germany
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Senftenberg, Germany
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Sindelfingen, Germany
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Sömmerda, Germany
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Speyer, Germany
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Stadthagen, Germany
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Starnberg, Germany
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Strausberg, Germany
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Stuttgart, Germany
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Taucha, Germany
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Ulm, Germany
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Unterschleissheim, Germany
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Velbert, Germany
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Villingen-Schwenningen, Germany
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Wiesbaden, Germany
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Wiesloch, Germany
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Wolfenbüttel, Germany
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Wolfsburg, Germany
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Wuppertal, Germany
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Zwickau, Germany
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Aveiro, Portugal
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Braga, Portugal
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Castelo Viegas, Portugal
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Estoril, Portugal
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Lisbon, Portugal
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Matosinhos Municipality, Portugal
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P-1100 Lisboa N/A, Portugal
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Portimão, Portugal
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Póvoa Do Varzim, Portugal
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Santo Tirso, Portugal
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A Coruña, Spain
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Alcorcón, Spain
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Alginet, Spain
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Alicante, Spain
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Almería, Spain
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Aravaca, Spain
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Avilés, Spain
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Badalona, Spain
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Barakaldo, Spain
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Barcelona, Spain
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Burgos, Spain
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Cadiz, Spain
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Calatayud, Spain
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Calella, Spain
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Castellon, Spain
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Ciudad Real, Spain
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Córdoba, Spain
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Cullera, Spain
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Donostia / San Sebastian, Spain
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el Prat de Llobregat, Spain
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Gandia, Spain
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Girona, Spain
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Granada, Spain
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Ibiza Town, Spain
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Jaén, Spain
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L'Hospitalet de Llobregat, Spain
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Las Palmas de Gran Canaria, Spain
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León, Spain
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Llanera, Spain
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Lleida, Spain
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Logroño, Spain
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Los Boliches, Spain
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Lugo, Spain
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Madrid, Spain
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Manacor, Spain
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Marbella, Spain
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Mataró, Spain
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Málaga, Spain
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Murcia, Spain
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Ontiyent, Spain
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Ourense, Spain
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Oviedo, Spain
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Palamós, Spain
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Palma de Mallorca, Spain
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Pamplona, Spain
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Parla, Spain
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Pontevedra, Spain
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Port de Bollenca, Spain
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Requena, Spain
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Ribeira, Spain
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Rota, Spain
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Sabadell, Spain
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Salamanca, Spain
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San Cristóbal de La Laguna, Spain
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San Sebastián de los Reyes, Spain
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Sanlúcar de Barrameda, Spain
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Sant Joan d'Alacant, Spain
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Santa Cruz de Tenerife, Spain
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Santander, Spain
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Santiago de Compostela, Spain
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Seville, Spain
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Silla, Spain
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Tarragona, Spain
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Terrassa, Spain
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Toledo, Spain
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Utrera, Spain
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Valencia, Spain
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Valladolid, Spain
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Vigo, Spain
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Vilanova i la Geltrú, Spain
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Villamayor, Spain
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Xátiva, Spain
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Zaragoza, Spain
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Billdal, Sweden
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Eskilstuna, Sweden
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Gothenburg, Sweden
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Karlshamn, Sweden
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Luleå, Sweden
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Lund, Sweden
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Motala, Sweden
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Stockholm, Sweden
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC C. Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2009
First Posted
November 30, 2009
Study Start
September 1, 2009
Study Completion
September 1, 2012
Last Updated
November 26, 2013
Record last verified: 2013-11