check_circleStudy Completed
Vasomotor Symptoms
Bayer Identifier:
91354
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Treatment of Vasomotor Symptoms in Korean Post Menopausal Women
Trial purpose
Study to demonstrate that the therapeutic efficacy of Angeliq® is better than placebo in Korean postmenopausal women with hot flushes and other climacteric symptoms. Safety and tolerability of Angeliq.
Key Participants Requirements
Sex
FemaleAge
45 - 65 YearsTrial summary
Enrollment Goal
90Trial Dates
July 2004 - May 2005Phase
Phase 3Could I Receive a placebo
YesProducts
Angeliq (E2/DRSP, BAY86-4891)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Seoul National University Hospital | Seoul, 110-744, Korea, Republic Of |
Completed | Samsung Medical Center | Seoul, 135-710, Korea, Republic Of |
Completed | Inje University Sanggye Paik Hospital | Seoul, Korea, Republic Of |
Terminated | Asan Medical Center | Seoul, 138-736, Korea, Republic Of |
Completed | Chung-Ang University Yongsan Hospital | Seoul, Korea, Republic Of |
Completed | Gangnam Severance Hospital, Yonsei University | Seoul, Korea, Republic Of |
Primary Outcome
- Hot flush (frequency and severity)date_rangeTime Frame:Daily in pre-treatment and treatment periodenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Menopausal symptomsdate_rangeTime Frame:Baseline and after 4 weeks, 8, 12 and 16 weeks of treatmentenhanced_encryptionnoSafety Issue:
- Urogenital symptomsdate_rangeTime Frame:Baseline and after 4 weeks, 8, 12 and 16 weeks of treatmentenhanced_encryptionnoSafety Issue:
- Assessment of bleedingdate_rangeTime Frame:daily in pre-treatment and treatment periodenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2