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Идёт набор NCT04478305

Affect of Duavive on Mood & Anxiety Symptoms

Фаза I С лечением Menopause Depression, Anxiety Sleep Menopause Related Conditions

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Duavive 0.45Mg-20Mg Tablet.
Кому может быть актуально
Состояния в реестре: Menopause, Depression, Anxiety, Sleep, Menopause Related Conditions. Базовые параметры: 45 лет — 60 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Официальное название

The Effect of Conjugated Estrogens/ Bazedoxifene (CE/ BZA) on Peri- and Postmenopausal Mood and Anxiety Symptoms: A Pilot Study

Обзор

This study evaluates the impact of conjugated estrogens/ bazedoxifene (CE/ BZA) on the mood (depression and anxiety) in peri- and early menopausal women.

Подробное описание

During the transition to menopause, women are at risk for developing symptoms of depression and anxiety, and impaired sleep. Fluctuation in estrogen levels appears to play a role in this. The investigators suspect that the administration of estrogens without progesterone, such as conjugated estrogens/ bazedoxifene (CE/ BZA), may improve mood symptoms in this population. In 2017, CE/ BZA was approved for menopausal vasomotor symptoms (VMS) in Canada, but the effect on mood were not examined closely.

The investigators propose a pilot study of 30 peri- and early postmenopausal women, currently seeking treatment for symptoms of depression or anxiety. The participants will go through a round of treatment with CE/BZA. The study will last 16 weeks. The study's objectives are to determine primarily if CE/BZA improves mood among peri- and early postmenopausal women, and secondarily if treatment with CE/BZA improves their sleep.

Вмешательства

  • Препарат Duavive 0.45Mg-20Mg Tablet
    Duavee, marketed as Duavive in Canada.

Первичные конечные точки

  • Depressive symptoms [Срок оценки: At 4 weeks weeks after beginning study]
  • Depressive symptoms [Срок оценки: At 8 weeks after beginning study]
  • Depressive symptoms [Срок оценки: At 12 weeks after beginning study]
  • Depressive symptoms [Срок оценки: At 16 weeks after beginning study]
  • Depressive symptoms [Срок оценки: At 4 weeks after beginning study]
  • Depressive symptoms [Срок оценки: At 8 weeks after beginning study]
  • Depressive symptoms [Срок оценки: At 12 weeks after beginning study]
  • Depressive symptoms [Срок оценки: At 16 weeks after beginning study]
  • Anxiety symptoms [Срок оценки: At 4 weeks after beginning study]
  • Anxiety symptoms [Срок оценки: At 8 weeks after beginning study]
Вторичные конечные точки (12)
  • Menopause symptoms [Срок оценки: At 4 weeks after beginning study]
  • Menopause symptoms [Срок оценки: At 8 weeks after beginning study]
  • Menopause symptoms [Срок оценки: At 12 weeks after beginning study]
  • Menopause symptoms [Срок оценки: At 16 weeks after beginning study]
  • Total nightly sleep time [Срок оценки: At 4 weeks after beginning study]
  • Total nightly sleep time [Срок оценки: At 8 weeks after beginning study]
  • Total nightly sleep time [Срок оценки: At 12 weeks after beginning study]
  • Total nightly sleep time [Срок оценки: At 16 weeks after beginning study]
  • Sleep onset latency [Срок оценки: At 4 weeks after beginning study]
  • Sleep onset latency [Срок оценки: At 8 weeks after beginning study]
  • Sleep onset latency [Срок оценки: At 12 weeks after beginning study]
  • Sleep onset latency [Срок оценки: At 16 weeks after beginning study]

Критерии участия

Критерии включения

  • Females between 45-60 years of age
  • Able to communicate in English
  • In perimenopause as defined by World Health Organization (WHO) Stages of Reproductive Aging Workshop (STRAW) criteria, OR in early menopause (within 10 years of final menstrual period)
  • Suffering from Depressive symptoms (10+ on CES-D-10) AND/OR anxiety symptoms (10+ on GAD-7)

Критерии исключения

  • Personal history of breast/ ovarian/ endometrial cancer/ endometrial hyperplasia.
  • Abnormal uterine bleeding that has not been adequately investigated.
  • Active or past venous or arterial thromboembolic disease (deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, coronary heart disease).
  • Active liver disease.
  • Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders.
  • Known or suspected pregnancy, women who may become pregnant, and nursing mothers
  • Partial or complete loss of vision due to ophthalmic vascular disease.
  • Uncontrolled hypertension (Systolic blood pressure >160mm Hg and/ or diastolic blood pressure >95 mm Hg)
  • Endocrine disease (other than thyroid disease) that may adversely affect mood (i.e., Cushing's disease, Addison's disease). For women with abnormal TSH, it will be corrected in advance of trial initiation.
  • Active serious suicidal ideation with intent.
  • Symptoms of active psychosis.
  • Daily use of antidepressive medication.
  • Use of other psychoactive or centrally acting medications within 2 weeks before study screening.
  • Known hypersensitivity to either CE or BZA.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • St Joseph's Healthcare — Hamilton

Идентификаторы

NCT: NCT04478305 · 2019-7333

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗