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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00356447
Recruitment Status : Completed
First Posted : July 26, 2006
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Vasomotor Symptoms Drug: Estradiol/DRSP (Angeliq, BAY86-4891) Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Study Start Date : May 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm 1 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 Comparator: Arm 2 Drug: Placebo
Same administration.


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of hot flushes [ Time Frame: From baseline to week 16 ]
  2. Change in intensity of hot flushes [ Time Frame: From baseline to week 16 ]

Secondary Outcome Measures :
  1. Change in other climacteric symptoms [ Time Frame: From baseline to week 16 ]
  2. Vaginal Bleeding pattern [ Time Frame: From baseline to week 16 ]
  3. Global clinical impression [ Time Frame: From baseline to week 16 ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356447


Locations
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China, Hubei
Wuhan, Hubei, China, 430032
China, Jiangsu
Nanjing, Jiangsu, China, 210029
China, Shandong
Jinan, Shandong, China, 250012
China
Beijing, China, 100020
Beijing, China, 100034
Beijing, China, 100083
Beijing, China, 100730
Chongqing, China, 400010
Shanghai, China, 200011
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00356447    
Other Study ID Numbers: 91442
309341 ( Other Identifier: Company internal )
First Posted: July 26, 2006    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs