check_circleStudy Completed
Postmenopause
Bayer Identifier:
91436
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Efficacy and Tolerability of Angeliq in Thai women
Trial purpose
To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms.
Key Participants Requirements
Sex
FemaleAge
45 YearsTrial summary
Enrollment Goal
55Trial Dates
September 2005 - December 2006Phase
Phase 4Could I Receive a placebo
NoProducts
Angeliq (E2/DRSP, BAY86-4891)Accepts Healthy Volunteer
NoPrimary Outcome
- The relative change in the frequency of hot flushesdate_rangeTime Frame:At baseline, week 4, 8, 12enhanced_encryptionNoneSafety Issue:
Secondary Outcome
- The change in intensity of hot flushesdate_rangeTime Frame:At baseline, week 4, 8, 12enhanced_encryptionNoneSafety Issue:
- The relative change in frequency of hot flushesdate_rangeTime Frame:At baseline, week 4, 8enhanced_encryptionNoneSafety Issue:
- The change in intensity of hot flushesdate_rangeTime Frame:At baseline, week 4, 8enhanced_encryptionNoneSafety Issue:
- The proportions of subjects with urogenital symptomsdate_rangeTime Frame:At baseline, week 4, 8, 12enhanced_encryptionNoneSafety Issue:
- Bleeding patterndate_rangeTime Frame:At baseline, week 4, 8, 12enhanced_encryptionNoneSafety Issue:
- Adverse events collectiondate_rangeTime Frame:Collection of AE throughout the study periodenhanced_encryptionNoneSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1