check_circleStudy Completed

Vasomotor symptoms

Bayer Identifier:

91442

ClinicalTrials.gov Identifier:

NCT00356447

EudraCT Number:

Not Available

EU CT Number:

Not Available
Safety/efficacy study of drospirenone/estradiol to treat postmenopausal Chinese women with vasomotor symptoms.

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.

Key Participants Requirements

Sex

Female

Age

45 - 65 Years
  • - Chinese postmenopausal women with moderate to severe vasomotor symptoms
  • - 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
249
Trial Dates
May 2006 - October 2007
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Angeliq (E2/DRSP, BAY86-4891)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Peking Union Medical College HospitalBeijing, 100730, China
Completed
Obstetrics & Gynecology Hosp. of Fudan Univ.Shanghai, 200011, China
Completed
2nd Hosp., Chongqing Medical Univ.Chongqing, 400010, China
Completed
1st Affiliated Hosp., of Nanjing Medical Univ.Nanjing, 210029, China
Completed
Peking Univ. First Hosp.Beijing, 100034, China
Completed
Peking University Third HospitalBeijing, 100083, China
Completed
Respiratory Diseases Institute, Beijing Chaoyang HospitalBeijing, 100020, China
Completed
Qilu Hosp., Shandong Univ.Jinan, 250012, China
Completed
Union hospital of Tongji Medical College,Huazhong universityWuhan, 430032, China

Primary Outcome

  • Frequency of hot flushes
    date_rangeTime Frame:
    From baseline to week 16
    enhanced_encryption
    Safety Issue:
    no
  • Change in intensity of hot flushes
    date_rangeTime Frame:
    From baseline to week 16
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Change in other climacteric symptoms
    date_rangeTime Frame:
    From baseline to week 16
    enhanced_encryption
    Safety Issue:
    no
  • Vaginal Bleeding pattern
    date_rangeTime Frame:
    From baseline to week 16
    enhanced_encryption
    Safety Issue:
    yes
  • Global clinical impression
    date_rangeTime Frame:
    From baseline to week 16
    enhanced_encryption
    Safety Issue:
    no

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

Additional Information

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