Trial Condition(s):
Postmenopause
Efficacy and Tolerability of Angeliq in Thai women
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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