SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study
|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.|
|ClinicalTrials.gov Identifier: NCT00511797|
Recruitment Status : Completed
First Posted : August 6, 2007
Results First Posted : October 4, 2010
Last Update Posted : January 26, 2017
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment|
Drug: SH T04740B
Drug: SH T00186DF
Drug: SH T04740F
Full Analysis Set (FAS) consisted of all patients who received at least one dose of study drug. Patients were analyzed as treated.
FAS was the primary analysis set for all efficacy endpoints and safety analyses. Per Protocol Set (PPS) was a subgroup of the FAS. The PPS consisted of patients in the FAS who did not have major protocol deviations.