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Клинические исследования в Украине

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Исследования / № 00244452

Описание
Краткое названиеA Multinational, Randomized, Double-Blind, Placebo??‘Controlled, Parallel Group Study to Investigate the Efficacy, Safety and Duration of Effect of a Single Administration of Various Doses of Cetrorelix SR in Subjects With Histologically Confirmed Endometriosis
Полное названиеA Multinational, Randomized, Double-Blind, Placebo??‘Controlled, Parallel Group Study to Investigate the Efficacy, Safety and Duration of Effect of a Single Administration of Various Doses of Cetrorelix SR in Subjects With Histologically Confirmed Endometriosis
СпонсорSolvay Pharmaceuticals
Industry
ИсточникSolvay Pharmaceuticals
Под контролемGermany: Federal Institute for Drugs and Medical Devices
Russia: Pharmacological Committee, Ministry of Health
Romania: State Institute for Drug Control
Bulgaria: Ministry of Health
Belgium: Ministry of Social Affairs, Public Health and the Environment
Australia: National Health and Medical Research Council
Краткое описаниеIdentify effective doses of cetrorelix SR in the treatment of symptoms of endometriosis,
describe dose effect relationship and duration of symptom relief
СостояниеЗавершено
Дата началаNovember 2005
ФазаPhase 2
Вид исследованияAllocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Набор0
КритерииInclusion Criteria:

- Premenopausal female,

- history of regular menstrual periods,

- any of the symptoms dysmenorrhea,

- dyspareunia or pelvic pain assessed as moderate to severe,

- endometriosis confirmed by histology within 36 months,

- use of barrier contraception throughout the study

Exclusion Criteria:

- Insufficient wash out period for other endometriosis treatments,

- resection or destruction of endometriotic lesions less than 12 weeks prior to
screening,

- need for strong opioid analgesics,

- need for immediate surgical treatment of endometriosis,

- any condition that interferes with adherence to study procedures or study assessments
ПолFemale
Минимальный возраст18 Years
Максимальный возраст45 Years
УсловиеEndometriosis
Применяемое лечение
DrugCetrorelix
Контакты и расположение
Dnepropetrovsk Site 3805
Donetsk Site 3801
Kiev Site 3803
Kiev Site 3808
Kiev Site 3806
Kiev Site 3807
Odessa Site 3802
Zaporozhye Site 3804
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