Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms.

Vasomotor Symptoms Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356447
• Other study ID #: 91442
• Secondary ID: 309341
• Status: Completed
• Phase: Phase 3
• First received: July 25, 2006
• Last updated: September 30, 2014
• Start date: May 2006
• Est. completion date: October 2007

Study information

• Verified date: September 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Vasomotor Symptoms

Intervention

Drug:
• Estradiol/DRSP (Angeliq, BAY86-4891)
Drospirenone (DRSP) 2mg and Estradiol 1mg. One cycle consists of 28 days. One tablet daily for 28 days given for a total of 4 cycles. Oral administration.
• Placebo
Same administration.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of hot flushes		From baseline to week 16	No
Primary	Change in intensity of hot flushes		From baseline to week 16	No
Secondary	Change in other climacteric symptoms		From baseline to week 16	No
Secondary	Vaginal Bleeding pattern		From baseline to week 16	Yes
Secondary	Global clinical impression		From baseline to week 16	No

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