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Endometrial Safety Study

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: NCT00522873
Recruitment Status : Completed
First Posted : August 30, 2007
Results First Posted : June 28, 2012
Last Update Posted : December 31, 2014
Sponsor:
Collaborators:
Laboratorium für Klinische Forschung
Diagnostic Cytology Laboratory
University of California, San Francisco
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE August 29, 2007
First Posted Date  ICMJE August 30, 2007
Results First Submitted Date  ICMJE March 23, 2012
Results First Posted Date  ICMJE June 28, 2012
Last Update Posted Date December 31, 2014
Study Start Date  ICMJE August 2007
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2012)
Number of Participants in the DRSP/E2 Group With an Assessment of Endometrial Hyperplasia or Worse at End of Study (EoS) (1 Year of Treatment) [ Time Frame: Up to one year ]
The number of women who had a biopsy classified as 'hyperplasia or worse' at any time during the study. According to the protocol this endpoint was defined as primary for the DRSP/E2 group only.
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2007)
The proportion of subjects with an assessment of endometrial hyperplasia or worse during or after one year of treatment. [ Time Frame: During or after one year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2012)
  • Number of Participants With Amenorrhea During Month 1 to 3 of Treatment [ Time Frame: Month 1 to Month 3 ]
    The women were to record daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval.
  • Number of Participants With Amenorrhea During Month 10 to 12 of Treatment [ Time Frame: Month 10 to Month 12 ]
    The women were to record any bleeding daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2007)
The incidence of amenorrhea (no bleeding or spotting) during months 1-3 and 10-12 of treatment. [ Time Frame: Months 1-3 and 10-12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endometrial Safety Study
Official Title  ICMJE A Double-blind, Randomized, Multi-center Study to Investigate the Endometrial Safety of a Continuous, Combined, Oral Estrogen/Progestin Preparation (17b-estradiol [E2] / Drospirenone [DRSP]) and to Compare the Bleeding Pattern of Subjects Treated With E2 / DRSP With the Bleeding Pattern of Subjects Treated With E2 / Norethisterone Acetate (NETA) When Used for Hormone Therapy (HT) for 1 Year in Post-menopausal Women
Brief Summary The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postmenopause
Intervention  ICMJE
  • Drug: 0.25mg DRSP / 0.5mg E2 (BAY86-4891)
    One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
  • Drug: 0.5mg NETA / 1.0mg E2 (Activella)
    One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
Study Arms  ICMJE
  • Experimental: 0.25mg DRSP / 0.5mg E2 (BAY86-4891)
    One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
    Intervention: Drug: 0.25mg DRSP / 0.5mg E2 (BAY86-4891)
  • Active Comparator: 0.5mg NETA / 1.0mg E2 (Activella)
    One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
    Intervention: Drug: 0.5mg NETA / 1.0mg E2 (Activella)
Publications * Genazzani AR, Schmelter T, Schaefers M, Gerlinger C, Gude K. One-year randomized study of the endometrial safety and bleeding pattern of 0.25 mg drospirenone/0.5 mg 17β-estradiol in postmenopausal women. Climacteric. 2013 Aug;16(4):490-8. doi: 10.3109/13697137.2013.783797. Epub 2013 May 11.

*   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: January 12, 2009)
662
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2007)
600
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Postmenopausal women between 40 and 65 years of age with hormone therapy indication (symptoms and need for treatment)
  • Non-hysterectomized women.

Exclusion Criteria:

  • Usual exclusion criteria for hormone therapy apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 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 Argentina,   Austria,   Brazil,   Denmark,   Italy,   Mexico,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00522873
Other Study ID Numbers  ICMJE 91508
2006-006199-39 ( EudraCT Number )
310523 ( Other Identifier: Company internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE
  • Laboratorium für Klinische Forschung
  • Diagnostic Cytology Laboratory
  • University of California, San Francisco
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2014

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