Trial Condition(s):
Vasomotor Symptoms
Treatment of Vasomotor Symptoms in Korean Post Menopausal Women
Bayer Identifier:
91354
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- Postmenopausal Korean women suffering from hot flushes
Exclusion Criteria
- Standard exclusion criteria for HRT clinical trials had to be obeyed, including current or history of hormone dependent malignant disease, thromboembolic disorders, abnormal cervical smear, undiagnosed vaginal bleeding.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Seoul National University Hospital Seoul, South Korea, 110-744 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samsung Medical Center Seoul, South Korea, 135-710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Inje University Sanggye Paik Hospital Seoul, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asan Medical Center Seoul, South Korea, 138-736 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chung-Ang University Yongsan Hospital Seoul, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gangnam Severance Hospital, Yonsei University Seoul, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A double-blind, randomized, placebo-controlled, multicenter study investigating the efficacy and tolerability of Angeliq(drospirenon2mg and estradiol 1mg) in postmenopausal Korean women with vasomotor symptoms over 3, 28 day treatment cycle
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Hot flush (frequency and severity)Timeframe: Daily in pre-treatment and treatment period
Secondary Outcome
- Menopausal symptomsTimeframe: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
- Urogenital symptomsTimeframe: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
- Assessment of bleedingTimeframe: daily in pre-treatment and treatment period
Additional Information
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