Trial Condition(s):
Postmenopause
Endometrial safety study
Bayer Identifier:
91508
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Dr. Guenther Heytmanek Wien, Austria, 1030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. Wollein Mödling, Austria, 2340 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. Norman Ruth Wörgl, Austria, 6300 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Sigrid Schmidl-Amann St. Poelten, Austria, 3100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Walter Paulik Zeltweg, Austria, 8740 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Innsbruck Innsbruck, Austria, 6020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. Barbara Eberz Mürzzuschlag, Austria, 8680 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Center for Clinical& Basic Research Alborg, Denmark, 9000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Center for Clinical & Basic Research Vejle, Denmark, 7100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Senese Siena, Italy, 53100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Bologna Bologna, Italy, 40138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Parma Parma, Italy, 43100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Scientific Research Center of Obst., Gyn. and Perinatology Moskva, Russia, 117997 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Scientific Research Center of Obst., Gyn. and Perinatology Moscow, Russia, 177997 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Municipal Hospital N 4 Moskva, Russia, 113093 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Moscow Regional Research Institue of Obstetrics & Gynecology Moskva, Russia, 101000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. Langer Fuerstenfeld, Austria, 8280 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Max Stiglbauer Wiener Neustadt, Austria, 2700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allgemeines Krankenhaus der Stadt Wien Universitätskliniken Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Wolfgang Bartl Wien, Austria, 1200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Ewald Boschitsch Wien, Austria, 1060 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Bernhard Svejda Klagenfurt, Austria, 9020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Landeskrankenhaus Bregenz Bregenz, Austria, 6900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Center for Clinical & Basic Research Ballerup, Denmark, 2750 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Pisana Pisa, Italy, 56126 | Status Completed | Contact Us: E-mail: [email protected]ealthcare.com Phone: Not Available |
Locations A.O.U. di Cagliari Cagliari, Italy, 09124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Sassari Sassari, Italy, 07100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Modena Policlinico Modena, Italy, 41124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Maggiore della Carità Novara, Italy, 28100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 31 State Hospital Moscow, Russia, 117415 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Médico de Asistencia e Investigación Buenos Aires, Argentina, C1117ABH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Ginecologico Buenos Aires Lanus Oeste, Argentina, 1824 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinica de la Mujer San Isidro Labrador - Ginec San Isidro, Argentina, B1642CLN | Status Completed | Contact Us: E-mail: clinical-trials-c[email protected] Phone: Not Available |
Locations Hospital Británico Buenos Aires, Argentina, C1280AEB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinica de la Mujer San Isidro Labrador - Ginec San Isidro, Argentina, B1642CLN | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Moinhos de Vento-Centro Clínico Porto Alegre, Brazil, 90035-001 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto de Saude e Bem Estar Mulher Sao Paulo, Brazil, 04062-003 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fundación Médica Sur CIF BIOTEC México, D.F., Mexico, 14050 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rapid Medical Research Inc. Cleveland, United States, 44122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Trial Center of Colorado Greenwood Village, United States, 80111 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Center for Clinical Research San Diego, United States, 92108 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations York Clinical Consulting Marrero, United States, 70072 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research of Philadelphia, LLC Philadelphia, United States, 19114 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Medical Research Group, LLC Clearwater, United States, 33759 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advanced Research Associates Corpus Christi, United States, 78414 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Tiempo Buenos Aires, Argentina, C1117ABH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Estudos e Pesquisas em Reproducao Humana e Fertil. Curitiba, Brazil, 80030-220 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations MAA Centro de Pesquisa Clinica Goiania, Brazil, 74175-080 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Nacional de Perinatología Mexico, Mexico | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital María José Mexico, Mexico, 06700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario "José Eleuterio González" Monterrey, Mexico, 64460 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Visions Clinical Research Boynton Beach, United States, 33437 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Genesis Center for Clinical Research San Diego, United States, 92103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Clinical Research, Inc. Richmond, United States, 23294 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Yekaterina Khronusova, MD Las Vegas, United States, 89122 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Clinical Research Center DBA Seattle Women's Health Seattle, United States, 98105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations South Carolina Clinical Research Center Columbia, United States, 29201 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations York Clinical Consulting Amite, United States, 70422 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Downtown Women's Healthcare Denver, United States, 80218 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advanced Clinical Research Boise, United States, 83704 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations East Valley Family Physicians, PLC Chandler, United States, 85224 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
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)Timeframe: Up to one year
Secondary Outcome
- Number of participants with amenorrhea during month 1 to 3 of treatmentTimeframe: Month 1 to Month 3
- Number of participants with amenorrhea during month 10 to 12 of treatmentTimeframe: Month 10 to Month 12
Additional Information
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