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Trial record 97 of 101 for:    ETHINYL ESTRADIOL AND DROSPIRENONE

Efficacy and Tolerability of Angeliq in Thai Women

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: NCT00185328
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 12, 2008
Sponsor:
Information provided by:
Bayer

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date December 12, 2008
Study Start Date  ICMJE September 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2008)
The relative change in the frequency of hot flushes [ Time Frame: At baseline, week 4, 8, 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
This study aims to evaluate the safety, tolerability and efficacy of Angeliq® in Thai postmenopausal women with hot flushes and other climacteric and urogenital symptoms.
Change History Complete list of historical versions of study NCT00185328 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2008)
  • The change in intensity of hot flushes [ Time Frame: At baseline, week 4, 8, 12 ]
  • The relative change in frequency of hot flushes [ Time Frame: At baseline, week 4, 8 ]
  • The change in intensity of hot flushes [ Time Frame: At baseline, week 4, 8 ]
  • The proportions of subjects with urogenital symptoms [ Time Frame: At baseline, week 4, 8, 12 ]
  • Bleeding pattern [ Time Frame: At baseline, week 4, 8, 12 ]
  • Adverse events collection [ Time Frame: Collection of AE throughout the study period ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Tolerability of Angeliq in Thai Women
Official Title  ICMJE A Multi-Center, Open-Label, Non-Comparative Study Investigating the Efficacy and Tolerability of Angeliq® in Postmenopausal Thai Women With Vasomotor Symptoms Over Three 28-Day Treatment Cycles
Brief Summary To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms.
Detailed Description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postmenopause
Intervention  ICMJE Drug: Estradiol/DRSP (Angeliq, BAY86-4891)
1 tablet of 2 mg drospirenone and 1 mg estradiol, orally administered once daily, over three 28-day treatment cycles
Study Arms  ICMJE Experimental: Arm 1
Intervention: Drug: Estradiol/DRSP (Angeliq, BAY86-4891)
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: December 11, 2008)
55
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Postmenopausal women with hot flushes

Exclusion Criteria:

  • Women with a contraindication for Hormone Replacement Therapy (HRT)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years and older   (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 Not Provided
Removed Location Countries Thailand
 
Administrative Information
NCT Number  ICMJE NCT00185328
Other Study ID Numbers  ICMJE 91436
309367
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Affairs Therapeutic Area Head, Bayer Schering Pharma AG
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2008

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