check_circleStudy Completed
Endometriosis
Bayer Identifier:
91233
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Efficacy and safety of SH T00660AA in treatment of endometriosis
Trial purpose
The purpose of this study is to demonstrate safety and efficacy of SH T00660AA compared to placebo in the treatment of endometriosis
Key Participants Requirements
Sex
FemaleAge
18 - 45 YearsTrial summary
Enrollment Goal
198Trial Dates
March 2004 - September 2006Phase
Phase 3Could I Receive a placebo
YesProducts
Visanne (Dienogest, BAY86-5258)Accepts Healthy Volunteer
NoPrimary Outcome
- Efficacydate_rangeTime Frame:Assessment of pain relief at end of treatmentenhanced_encryptionNoneSafety Issue:
Secondary Outcome
- Adverse event collectiondate_rangeTime Frame:Assessment at end of studyenhanced_encryptionNoneSafety Issue:
- Treatment satisfaction by patientdate_rangeTime Frame:Assessment at end of studyenhanced_encryptionNoneSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2