Trial Condition(s):
Postmenopause
Efficacy and Tolerability of Angeliq in Thai women
Bayer Identifier:
91436
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms.
Inclusion Criteria
- Postmenopausal women with hot flushes
Exclusion Criteria
- Women with a contraindication for Hormone Replacement Therapy (HRT)
Trial Summary
Enrollment Goal
55
Trial Dates
Phase
4
Could I receive a placebo?
No
Products
Angeliq (E2/DRSP, BAY86-4891)
Accepts Healthy Volunteers
No
Where to Participate
Locations
Status
| Locations | Status |
|---|
Trial Design
A multi-center, open-label, non-comparative study investigating the efficacy and tolerability of Angeliq® in postmenopausal Thai women with vasomotor symptoms over three 28-day treatment cycles
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- The relative change in the frequency of hot flushesTimeframe: At baseline, week 4, 8, 12
Secondary Outcome
- The change in intensity of hot flushesTimeframe: At baseline, week 4, 8, 12
- The relative change in frequency of hot flushesTimeframe: At baseline, week 4, 8
- The change in intensity of hot flushesTimeframe: At baseline, week 4, 8
- The proportions of subjects with urogenital symptomsTimeframe: At baseline, week 4, 8, 12
- Bleeding patternTimeframe: At baseline, week 4, 8, 12
- Adverse events collectionTimeframe: Collection of AE throughout the study period
Additional Information
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