Клинические исследования в Украине

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Исследования / № 00307801

Краткое названиеEfficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding
Полное названиеA Multicenter, Double-blind, Randomized, Parallel-group, Placebo Controlled, 7 Cycle Duration of Oral SH T00658ID Tablets for the Treatment of Dysfunctional Uterine Bleeding
Под контролемNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Finland: Finnish Medicines Agency
Hungary: National Institute of Pharmacy
Poland: Ministry of Health
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Ukraine: State Pharmacological Center - Ministry of Health
Краткое описаниеThe purpose of this study is to determine whether the study drug is safe and effective in
the treatment of dysfunctional uterine bleeding.
Дата началаFebruary 2006
ФазаPhase 3
Подробное описаниеThe study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Вид исследованияAllocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
КритерииInclusion Criteria:

- Women 18 years or older with a diagnosis of dysfunctional uterine bleeding with at
least one of the following symptoms: prolonged, frequent or excessive bleeding.

Exclusion Criteria:

- The use of steroidal oral contraceptives, or any drug that could alter oral
contraception metabolism will be prohibited during the study. Women with a history
of endometrial ablation or dilatation and curettage within 2 months prior to study
start will be excluded.
Минимальный возраст18 Years
Максимальный возрастN/A
Применяемое лечение
DrugQlaira (BAY86-5027, SH T00658ID)
Контакты и расположение
Kiev , 01034
Kyiv , 01030
Kyiv , 04210
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