check_circleStudy Completed

Postmenopause

Bayer Identifier:

91508

ClinicalTrials.gov Identifier:

NCT00522873

EudraCT Number:

2006-006199-39

EU CT Number:

Not Available
Endometrial safety study

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

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

Trial summary

Enrollment Goal
662
Trial Dates
August 2007 - August 2009
Phase
Phase 3
Could I Receive a placebo
No
Products
Low-Dose E2/DRSP (BAY86-4891)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Dr. Guenther HeytmanekWien, 1030, Austria
Completed
Praxis Dr. WolleinMödling, 2340, Austria
Completed
Praxis Dr. Norman RuthWörgl, 6300, Austria
Completed
Dr. Sigrid Schmidl-AmannSt. Poelten, 3100, Austria
Terminated
Dr. Walter PaulikZeltweg, 8740, Austria
Completed
Universitätsklinikum InnsbruckInnsbruck, 6020, Austria
Completed
Praxis Fr. Dr. Barbara EberzMürzzuschlag, 8680, Austria
Completed
Center for Clinical& Basic ResearchAlborg, 9000, Denmark
Completed
Center for Clinical & Basic ResearchVejle, 7100, Denmark
Completed
A.O.U. SeneseSiena, 53100, Italy
Completed
A.O.U. di BolognaBologna, 40138, Italy
Completed
A.O.U. di ParmaParma, 43100, Italy
Completed
Scientific Research Center of Obst., Gyn. and PerinatologyMoskva, 117997, Russia
Terminated
Scientific Research Center of Obst., Gyn. and PerinatologyMoscow, 177997, Russia
Completed
Municipal Hospital N 4Moskva, 113093, Russia
Completed
Moscow Regional Research Institue of Obstetrics & GynecologyMoskva, 101000, Russia
Terminated
Praxis Dr. LangerFuerstenfeld, 8280, Austria
Completed
Dr. Max StiglbauerWiener Neustadt, 2700, Austria
Completed
Allgemeines Krankenhaus der Stadt Wien UniversitätsklinikenWien, 1090, Austria
Completed
Dr. Wolfgang BartlWien, 1200, Austria
Completed
Dr. Ewald BoschitschWien, 1060, Austria
Completed
Dr. Bernhard SvejdaKlagenfurt, 9020, Austria
Completed
Landeskrankenhaus BregenzBregenz, 6900, Austria
Completed
Center for Clinical & Basic ResearchBallerup, 2750, Denmark
Completed
A.O.U. PisanaPisa, 56126, Italy
Completed
A.O.U. di CagliariCagliari, 09124, Italy
Completed
A.O.U. di SassariSassari, 07100, Italy
Completed
A.O.U. di Modena PoliclinicoModena, 41124, Italy
Completed
A.O.U. Maggiore della CaritàNovara, 28100, Italy
Completed
31 State HospitalMoscow, 117415, Russia
Completed
Instituto Médico de Asistencia e InvestigaciónBuenos Aires, C1117ABH, Argentina
Completed
Instituto Ginecologico Buenos AiresLanus Oeste, 1824, Argentina
Completed
Clinica de la Mujer San Isidro Labrador - GinecSan Isidro, B1642CLN, Argentina
Completed
Hospital BritánicoBuenos Aires, C1280AEB, Argentina
Terminated
Clinica de la Mujer San Isidro Labrador - GinecSan Isidro, B1642CLN, Argentina
Terminated
Hospital Moinhos de Vento-Centro ClínicoPorto Alegre, 90035-001, Brazil
Terminated
Instituto de Saude e Bem Estar MulherSao Paulo, 04062-003, Brazil
Completed
Fundación Médica Sur CIF BIOTECMéxico, D.F., 14050, Mexico
Completed
Rapid Medical Research Inc.Cleveland, 44122, United States
Terminated
Clinical Trial Center of ColoradoGreenwood Village, 80111, United States
Completed
Medical Center for Clinical ResearchSan Diego, 92108, United States
Completed
York Clinical ConsultingMarrero, 70072, United States
Completed
Clinical Research of Philadelphia, LLCPhiladelphia, 19114, United States
Completed
Women's Medical Research Group, LLCClearwater, 33759, United States
Completed
Advanced Research AssociatesCorpus Christi, 78414, United States
Completed
Centro TiempoBuenos Aires, C1117ABH, Argentina
Terminated
Centro de Estudos e Pesquisas em Reproducao Humana e Fertil.Curitiba, 80030-220, Brazil
Terminated
MAA Centro de Pesquisa ClinicaGoiania, 74175-080, Brazil
Completed
Instituto Nacional de PerinatologíaMexico, Mexico
Completed
Hospital María JoséMexico, 06700, Mexico
Terminated
Hospital Universitario "José Eleuterio González"Monterrey, 64460, Mexico
Terminated
Visions Clinical ResearchBoynton Beach, 33437, United States
Completed
Genesis Center for Clinical ResearchSan Diego, 92103, United States
Completed
National Clinical Research, Inc.Richmond, 23294, United States
Terminated
Dr. Yekaterina Khronusova, MDLas Vegas, 89122, United States
Completed
Women's Clinical Research Center DBA Seattle Women's HealthSeattle, 98105, United States
Completed
South Carolina Clinical Research CenterColumbia, 29201, United States
Terminated
York Clinical ConsultingAmite, 70422, United States
Completed
Downtown Women's HealthcareDenver, 80218, United States
Completed
Advanced Clinical ResearchBoise, 83704, United States
Completed
East Valley Family Physicians, PLCChandler, 85224, United States

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)
    date_rangeTime Frame:
    Up to one year
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Number of participants with amenorrhea during month 1 to 3 of treatment
    date_rangeTime Frame:
    Month 1 to Month 3
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with amenorrhea during month 10 to 12 of treatment
    date_rangeTime Frame:
    Month 10 to Month 12
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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