Endometrial Safety Study
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
3 other identifiers
interventional
662
8 countries
59
Brief Summary
The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2007
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 29, 2007
CompletedFirst Posted
Study publicly available on registry
August 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
June 28, 2012
CompletedDecember 31, 2014
December 1, 2014
2 years
August 29, 2007
March 23, 2012
December 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
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.
Up to one year
Secondary Outcomes (2)
Number of Participants With Amenorrhea During Month 1 to 3 of Treatment
Month 1 to Month 3
Number of Participants With Amenorrhea During Month 10 to 12 of Treatment
Month 10 to Month 12
Study Arms (2)
0.25mg DRSP / 0.5mg E2 (BAY86-4891)
EXPERIMENTALOne capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle).
0.5mg NETA / 1.0mg E2 (Activella)
ACTIVE COMPARATOROne capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle).
Interventions
One capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle).
One capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle).
Eligibility Criteria
You may qualify if:
- Postmenopausal women between 40 and 65 years of age with hormone therapy indication (symptoms and need for treatment)
- Non-hysterectomized women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Laboratorium für Klinische Forschungcollaborator
- Diagnostic Cytology Laboratorycollaborator
- University of California, San Franciscocollaborator
Study Sites (59)
Unknown Facility
Chandler, Arizona, 85224, United States
Unknown Facility
San Diego, California, 92103, United States
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San Diego, California, 92108, United States
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Denver, Colorado, 80218, United States
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Greenwood Village, Colorado, 80111, United States
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Boynton Beach, Florida, 33437, United States
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Clearwater, Florida, 33759, United States
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Boise, Idaho, 83704, United States
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Amite, Louisiana, 70422, United States
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Marrero, Louisiana, 70072, United States
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Las Vegas, Nevada, 89122, United States
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Cleveland, Ohio, 44122, United States
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Philadelphia, Pennsylvania, 19114, United States
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Columbia, South Carolina, 29201, United States
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Corpus Christi, Texas, 78414, United States
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Richmond, Virginia, 23294, United States
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Seattle, Washington, 98105, United States
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Lanús Oeste, Buenos Aires, 1824, Argentina
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San Isidro, Buenos Aires, B1642CLN, Argentina
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Buenos Aires, Ciudad Auton. de Buenos Aires, C1117ABH, Argentina
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Buenos Aires, Ciudad Auton. de Buenos Aires, C1280AEB, Argentina
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Mödling, Lower Austria, 2340, Austria
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Wiener Neustadt, Lower Austria, 2700, Austria
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Fürstenfeld, Styria, 8280, Austria
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Wörgl, Tyrol, 6300, Austria
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Bregenz, Vorarlberg, 6900, Austria
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Innsbruck, 6020, Austria
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Klagenfurt, 9020, Austria
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Mürzzuschlag, 8680, Austria
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Sankt Pölten, 3100, Austria
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Vienna, 1030, Austria
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Vienna, 1060, Austria
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Vienna, 1090, Austria
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Vienna, 1200, Austria
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Zeltweg, 8740, Austria
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Goiânia, Goiás, 74175-080, Brazil
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Curitiba, Paraná, 80030-220, Brazil
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Porto Alegre, Rio Grande do Sul, 90035-001, Brazil
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São Paulo, São Paulo, 04062-003, Brazil
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Aalborg, 9000, Denmark
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Ballerup Municipality, 2750, Denmark
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Vejle, 7100, Denmark
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Bologna, 40138, Italy
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Cagliari, 09124, Italy
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Modena, 41124, Italy
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Novara, 28100, Italy
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Parma, 43100, Italy
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Pisa, 56126, Italy
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Sassari, 07100, Italy
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Siena, 53100, Italy
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Mexico City, Mexico City, Mexico
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México, 06700, Mexico
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México, D.F., 14050, Mexico
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Monterrey, 64460, Mexico
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Moscow, 117415, Russia
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Moscow, 177997, Russia
Unknown Facility
Moskva, 101000, Russia
Unknown Facility
Moskva, 113093, Russia
Unknown Facility
Moskva, 117997, Russia
Related Publications (1)
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 17beta-estradiol in postmenopausal women. Climacteric. 2013 Aug;16(4):490-8. doi: 10.3109/13697137.2013.783797. Epub 2013 May 11.
PMID: 23531117RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer HealthCare AG
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2007
First Posted
August 30, 2007
Study Start
August 1, 2007
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
December 31, 2014
Results First Posted
June 28, 2012
Record last verified: 2014-12