Efficacy and Tolerability of Angeliq in Thai Women
Phase 4
Completed
- Conditions
- Postmenopause
- Interventions
- Drug: Estradiol/DRSP (Angeliq, BAY86-4891)
- Registration Number
- NCT00185328
- Lead Sponsor
- Bayer
- Brief Summary
To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms.
- Detailed Description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 55
Inclusion Criteria
- Postmenopausal women with hot flushes
Exclusion Criteria
- Women with a contraindication for Hormone Replacement Therapy (HRT)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Estradiol/DRSP (Angeliq, BAY86-4891) -
- Primary Outcome Measures
Name Time Method The relative change in the frequency of hot flushes At baseline, week 4, 8, 12
- Secondary Outcome Measures
Name Time Method The change in intensity of hot flushes At baseline, week 4, 8 The relative change in frequency of hot flushes At baseline, week 4, 8 The proportions of subjects with urogenital symptoms At baseline, week 4, 8, 12 Bleeding pattern At baseline, week 4, 8, 12 Adverse events collection Collection of AE throughout the study period