Official Title: “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”

Study to demonstrate that the therapeutic efficacy of Angeliq® is superior to placebo in Korean postmenopausal women with hot flushes and other climacteric symptoms.

Safety and tolerability of Angeliq®.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Angeliq® (2 mg drospirenone and 1 mg estradiol)
  • Treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.
• Drug: Placebo
  • Treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
  • n/a
• Placebo Comparator: Arm 2
  • n/a

Primary Measures

• Hot flush (frequency and severity)
  • Time Frame: Daily in pre-treatment and treatment period
    Safety Issue?: No

Secondary Measures

• Menopausal symptoms
  • Time Frame: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
    Safety Issue?: No
• Urogenital symptoms
  • Time Frame: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
    Safety Issue?: No
• Assessment of bleeding
  • Time Frame: daily in pre-treatment and treatment period
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00651599

Study ID Number: 91354

ClinicalTrials.gov Identifier: NCT00651599

Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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