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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

Tracking Information
First Submitted Date  ICMJE July 25, 2006
First Posted Date  ICMJE July 26, 2006
Last Update Posted Date October 1, 2014
Study Start Date  ICMJE May 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2007)
  • Frequency of hot flushes [ Time Frame: From baseline to week 16 ]
  • Change in intensity of hot flushes [ Time Frame: From baseline to week 16 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 25, 2006)
  • Frequency of hot flushes from base to treatment (week 3 to 16).
  • Change in intensity of hot flushes from baseline to week 16.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2008)
  • Change in other climacteric symptoms [ Time Frame: From baseline to week 16 ]
  • Vaginal Bleeding pattern [ Time Frame: From baseline to week 16 ]
  • Global clinical impression [ Time Frame: From baseline to week 16 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2006)
  • Change in other climacteric symptoms
  • Bleeding pattern
  • Global clinical impression
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms.
Official Title  ICMJE 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Vasomotor Symptoms
Intervention  ICMJE
  • 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.
  • Drug: Placebo
    Same administration.
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Intervention: Drug: Estradiol/DRSP (Angeliq, BAY86-4891)
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2008)		 249
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00356447
Other Study ID Numbers  ICMJE 91442
309341 ( Other Identifier: Company internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bayer
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Bayer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP