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Endometrial Safety Study

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postmenopause

Intervention: 0.25mg DRSP / 0.5mg E2 (BAY86-4891) (Drug); 0.5mg NETA / 1.0mg E2 (Activella) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer


The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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)

Secondary outcome:

Number of Participants With Amenorrhea During Month 1 to 3 of Treatment

Number of Participants With Amenorrhea During Month 10 to 12 of Treatment


Minimum age: 40 Years. Maximum age: 65 Years. Gender(s): Female.


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.

Locations and Contacts

Innsbruck 6020, Austria

Klagenfurt 9020, Austria

Mürzzuschlag 8680, Austria

St. Poelten 3100, Austria

Wien 1060, Austria

Wien 1030, Austria

Wien 1090, Austria

Wien 1200, Austria

Zeltweg 8740, Austria

Sao Paulo 04062-003, Brazil

Alborg 9000, Denmark

Ballerup 2750, Denmark

Vejle 7100, Denmark

Bologna 40138, Italy

Cagliari 09124, Italy

Modena 41124, Italy

Novara 28100, Italy

Parma 43100, Italy

Pisa 56126, Italy

Sassari 07100, Italy

Siena 53100, Italy

Mexico 06700, Mexico

Monterrey 64460, Mexico

México, D.F. 14050, Mexico

Moscow 117415, Russian Federation

Moscow 177997, Russian Federation

Moskva 101000, Russian Federation

Moskva 113093, Russian Federation

Moskva 117997, Russian Federation

Chandler, Arizona 85224, United States

Lanus Oeste, Buenos Aires 1824, Argentina

San Isidro, Buenos Aires B1642CLN, Argentina

San Diego, California 92103, United States

San Diego, California 92108, United States

Buenos Aires, Ciudad Auton. de Buenos Aires C1117ABH, Argentina

Buenos Aires, Ciudad Auton. de Buenos Aires C1280AEB, Argentina

Denver, Colorado 80218, United States

Greenwood Village, Colorado 80111, United States

Mexico, Distrito Federal, Mexico

Boynton Beach, Florida 33437, United States

Clearwater, Florida 33759, United States

Goiania, Goiás 74175-080, Brazil

Boise, Idaho 83704, United States

Amite, Louisiana 70422, United States

Marrero, Louisiana 70072, United States

Las Vegas, Nevada 89122, United States

Mödling, Niederösterreich 2340, Austria

Wiener Neustadt, Niederösterreich 2700, Austria

Cleveland, Ohio 44122, United States

Curitiba, Parana 80030-220, Brazil

Philadelphia, Pennsylvania 19114, United States

Porto Alegre, Rio Grande do Sul 90035-001, Brazil

Columbia, South Carolina 29201, United States

Fuerstenfeld, Steiermark 8280, Austria

Corpus Christi, Texas 78414, United States

Wörgl, Tirol 6300, Austria

Richmond, Virginia 23294, United States

Bregenz, Vorarlberg 6900, Austria

Seattle, Washington 98105, United States

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here to find results for studies related to Bayer Healthcare products.

click here and search for Bayer Product information provided by the EMA

Starting date: August 2007
Last updated: December 10, 2014

Page last updated: August 23, 2015

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