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

Phase 3

Completed

• Conditions: Vasomotor Symptoms
• Interventions: Drug: Estradiol/DRSP (Angeliq, BAY86-4891); Drug: Placebo

• Registration Number: NCT00356447
• Lead Sponsor: Bayer

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-07-25
• Study First Submitted QC: 2006-07-25
• Study First Posted: 2006-07-26
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-30
• Last Update Posted: 2014-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 249

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Estradiol/DRSP (Angeliq, BAY86-4891)	-
Arm 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Frequency of hot flushes	From baseline to week 16
Change in intensity of hot flushes	From baseline to week 16

Secondary Outcome Measures

Name	Time	Method
Global clinical impression	From baseline to week 16
Vaginal Bleeding pattern	From baseline to week 16
Change in other climacteric symptoms	From baseline to week 16