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Trial NCT00185224

Resource URI: http://static.linkedct.org/resource/trials/NCT00185224
PropertyValue
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/33764>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/33951>
linkedct:brief_title Metabolism Study to Investigate the Impact of a Sequential Oral Contraceptive
linkedct:condition <http://static.linkedct.org/resource/condition/3300>
linkedct:criteria Inclusion Criteria: - Healthy female volunteers between 18 and 50 years requiring contraception Exclusion Criteria: - Pregnancy or lactation. - Any conditions that might interfere with the outcome as well as all contraindications for OC use
linkedct:description The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Female
linkedct:eligibility_healthy_volunteers Accepts Healthy Volunteers
linkedct:eligibility_maximum_age 50 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date March 2006
linkedct:enrollment 58 (xsd:int)
linkedct:firstreceived_date September 10, 2005
linkedct:id NCT00185224
linkedct:intervention <http://static.linkedct.org/resource/intervention/113636>
linkedct:intervention <http://static.linkedct.org/resource/intervention/82870>
rdfs:label Trial NCT00185224
linkedct:lastchanged_date April 23, 2009
linkedct:lead_sponsor_agency Bayer
linkedct:nct_id NCT00185224
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Single-Center, Open-Label, Controlled, Randomized Study to Investigate the Impact of a Sequential Oral Contraceptive (SH T00658ID) as Compared to a Sequential Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D00264A) on Plasma Lipids, Hemostatic Variables, and Carbohydrate Metabolism in Healthy Female Volunteers Aged 18-50 Years Over 7 Treatment Cycles, Including the Pharmacokinetics
linkedct:org_study_id 90927
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/5404>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/1106>
linkedct:oversight <http://static.linkedct.org/resource/oversight/1134>
foaf:page <http://clinicaltrials.gov/show/NCT00185224>
linkedct:phase Phase 2
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/58033>
linkedct:secondary_id 301886
linkedct:secondary_id EudraCT Nr.: 2004-001614-13
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/65948>
linkedct:source Bayer
linkedct:start_date March 2005
linkedct:study_design Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to confirm the safety of SH T00658ID with regard to plasma lipids, hemostatic variables, and carbohydrate metabolism. In addition, the pharmacokinetic parameter following the long term administration of SH T00658ID will be assessed.
rdf:type linkedct:trials
linkedct:verification_date April 2009