Trial Condition(s):
Vasomotor Symptoms
Safety/efficacy study of drospirenone/estradiol to treat postmenopausal Chinese women with vasomotor symptoms.
Bayer Identifier:
91442
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The study evaluates in Chinese post-menopausal women the combination of drospirenone 2 mg and estradiol 1 mg for the treatment of climacteric symptoms, such as hot flushes (vasomotor symptoms) and uro-genital complaints.
Inclusion Criteria
- Chinese postmenopausal women with moderate to severe vasomotor symptoms
Exclusion Criteria
- History of steroid hormone dependent malignant disease - Known or suspected malignant or premalignant disease - Current or history of severe heart, liver, renal, psychiatric disease - Hyperlipemia
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Peking Union Medical College Hospital Beijing, China, 100730 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Obstetrics & Gynecology Hosp. of Fudan Univ. Shanghai, China, 200011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 2nd Hosp., Chongqing Medical Univ. Chongqing, China, 400010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 1st Affiliated Hosp., of Nanjing Medical Univ. Nanjing, China, 210029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peking Univ. First Hosp. Beijing, China, 100034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peking University Third Hospital Beijing, China, 100083 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Respiratory Diseases Institute, Beijing Chaoyang Hospital Beijing, China, 100020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Qilu Hosp., Shandong Univ. Jinan, China, 250012 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Union hospital of Tongji Medical College,Huazhong university Wuhan, China, 430032 | 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® (drospirenone 2mg and estradiol 1mg) in postmenopausal Chinese women with vasomotor symptoms over four 28-day treatment cycles.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Frequency of hot flushesTimeframe: From baseline to week 16
- Change in intensity of hot flushesTimeframe: From baseline to week 16
Secondary Outcome
- Change in other climacteric symptomsTimeframe: From baseline to week 16
- Vaginal Bleeding patternTimeframe: From baseline to week 16
- Global clinical impressionTimeframe: From baseline to week 16
Additional Information
Copyright © Bayer
Powered by
