Clinical trial NCT00522873: Endometrial Safety Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopause
Keywords: Postmenopausal Symptoms e.g.
Hot flushes
Sweating episodes
Vaginal dryness
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Laboratorium für Klinische Forschung
name: Diagnostic Cytology Laboratory
name: University of California, San Francisco
First posted: 2007-08-30
Enrollment: 662
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: Up to one year
Secondary outcomes:
measure: Number of Participants With Amenorrhea During Month 1 to 3 of Treatment
timeFrame: Month 1 to Month 3
measure: Number of Participants With Amenorrhea During Month 10 to 12 of Treatment
timeFrame: Month 10 to Month 12
Other outcomes:
Locations:
city: Chandler
country: United States
state: Arizona
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Greenwood Village
country: United States
state: Colorado
city: Boynton Beach
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Amite
country: United States
state: Louisiana
city: Marrero
country: United States
state: Louisiana
city: Las Vegas
country: United States
state: Nevada
city: Cleveland
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Corpus Christi
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Lanus Oeste
country: Argentina
state: Buenos Aires
city: San Isidro
country: Argentina
state: Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Mödling
country: Austria
state: Niederösterreich
city: Wiener Neustadt
country: Austria
state: Niederösterreich
city: Fuerstenfeld
country: Austria
state: Steiermark
city: Wörgl
country: Austria
state: Tirol
city: Bregenz
country: Austria
state: Vorarlberg
city: Innsbruck
country: Austria
city: Klagenfurt
country: Austria
city: Mürzzuschlag
country: Austria
city: St. Poelten
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Zeltweg
country: Austria
city: Goiania
country: Brazil
state: Goiás
city: Curitiba
country: Brazil
state: Parana
city: Porto Alegre
country: Brazil
state: Rio Grande do Sul
city: Sao Paulo
country: Brazil
city: Alborg
country: Denmark
city: Ballerup
country: Denmark
city: Vejle
country: Denmark
city: Bologna
country: Italy
city: Cagliari
country: Italy
city: Modena
country: Italy
city: Novara
country: Italy
city: Parma
country: Italy
city: Pisa
country: Italy
city: Sassari
country: Italy
city: Siena
country: Italy
city: Mexico
country: Mexico
state: Distrito Federal
city: Mexico
country: Mexico
city: Monterrey
country: Mexico
city: México, D.F.
country: Mexico
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moskva
country: Russian Federation
city: Moskva
country: Russian Federation
city: Moskva
country: Russian Federation
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.