Treatment of Vasomotor Symptoms in Korean Post Menopausal Women

Vasomotor Symptoms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00651599
• Other study ID #: 91354
• Secondary ID: 308381
• Status: Completed
• Phase: Phase 3
• First received: April 1, 2008
• Last updated: December 30, 2014
• Start date: July 2004
• Est. completion date: May 2005

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vasomotor Symptoms

Intervention

Drug:
• Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.
• Placebo
Placebo treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hot flush (frequency and severity)		Daily in pre-treatment and treatment period	No
Secondary	Menopausal symptoms		Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment	No
Secondary	Urogenital symptoms		Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment	No
Secondary	Assessment of bleeding		daily in pre-treatment and treatment period	No

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