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Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women

2019年10月11日更新者：Hospital de Clinicas de Porto Alegre

Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women: a Randomized, Double-blind Controlled Trial

Arthralgia has been a common complaint in postmenopausal period which seems to be involved with estrogen depletion, although, its pathophysiology isn´t completely clarified. It seems to relate with the level of physical activity, climacteric symptoms and pain catastrophizing. In view of the multiple dimensions involved in arthralgia in postmenopausal women which characterize it as a complex phenomenon, this study aims to describe the effects of hormone replacement therapy in women aged between 45 and 55 years, considering estrogen as a possible anti-nociceptive factor.

調査の概要

状態

わからない

条件

関節痛

介入・治療

詳細な説明

This study is a randomized double-blind controlled clinical trial with postmenopausal women aged between 45 and 55 years with chronic arthralgia related to climacteric. They will be evaluated climacteric symptoms, pain intensity, level of physical activity, pain catastrophising, depression, anxiety, quality of sleep and quality of life. The volunteers will be randomized, in the proportion 1:1, to treatment with either 0,625 mg conjugated equine estrogen, via oral administration, for 12 weeks or placebo, via oral administration, for 12 weeks. The randomization will be performed by a computer-generated random numbers list. The investigators will be blinded until completion of 12 weeks. Evaluation of climacteric symptoms, pain intensity, level of physical activity, pain catastrophising, depression, anxiety, quality of sleep and quality of life will be performed in the hospital at baseline, 1, 2, 3, 6 months and 15 days. In each visit, participants will be evaluated about adverse effects such as diarrhea, nausea and vomit.

研究の種類

介入

入学 (予想される)

段階

フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

ブラジル
- Rio Grande Do Sul
  - Porto Alegre、Rio Grande Do Sul、ブラジル
    - 募集
    - Comitê de Ética em Pesquisa do Hospital de Clínicas de Porto Alegre
    - コンタクト：
      
      Maria Celeste Osório Wender, Ph.D
      
      電話番号：+55513359-8117
      
      メール：mceleste@ufrgs.br
    - コンタクト：
      
      Fernanda Vargas Ferreira, Ph.D
      
      電話番号：+55513359-8117
      
      メール：fernandaferreira@unipampa.edu.br

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

45年～55年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

説明

Inclusion Criteria:

age between 45 and 55 years
chronic arthralgia related to climacteric
regular mammography and pap smear test in the last twelve months
availability to attend hormone replacement therapy
maximum of ten years of amenorrhea according to the criteria of Stages of Reproductive Aging Workshop (STRAW)
without use of hormone replacement therapy, at least, previous six months
no contraindication to hormone replacement therapy (current or past of breast and / or cervical cancer, severe current or recent heart disease, thromboembolism, hypertension with no control, metabolic diseases (but stable thyroid disease) and endometrial hyperplasia to be enlightened
Informed consent

Exclusion Criteria:

autoimmune diseases
visceral pain (chronic pelvic pain, dyspareunia, irritable bowel syndrome)
systemic diseases (rheumatic, neurological, oncology, sexually transmitted infection)
body mass index of 30 or greater
soy diet
abuse of alcohol and drugs
large surgeries

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

主な目的：処理
割り当て：ランダム化
介入モデル：並列代入
マスキング：ダブル

アーム数

武器と介入

参加者グループ / アーム	介入・治療
実験的：Conjugated Equine Estrogen Thirty-six healthy postmenopausal women aged between 45 and 55 years will receive 0,625 mg/day conjugated equine estrogen (CEE) for 12 weeks. These 1 active pill containing conjugated equine estrogen, 0,625 mg will be provided by a laboratory with no trademark identification. The bottles will be numbered in code by a pharmaceutist not involved directly in study and they will donated to volunteers. During the intervening period, use of conjugated equine estrogen, there will be blinding. After this phase, blinding will be interrupted in order to identify volunteers who used the active drug.	薬：Conjugated Equine Estrogen Use of conjugated equine estrogen for 12 weeks. Adherence will be monitored during periodical hospital visits in order to receive pills. 他の名前： Drug active
プラセボコンパレーター：Placebo Thirty-six healthy postmenopausal women aged between 45 and 55 years will receive placebo pills, identical in size, shape and color to the active drug, via oral administration, for 12 weeks. The bottles, without trademark identification, will be numbered in code by a pharmaceutist not involved directly in study and they will donated to volunteers. During the intervening period, use of placebo, there will be blinding. After this phase, blinding will be interrupted in order to identify volunteers who used the active drug and placebo.	薬：Placebo Use of placebo for 12 weeks. Adherence will be monitored during periodical hospital visits in order to receive pills.

参加者グループ / アーム

介入・治療

実験的：Conjugated Equine Estrogen

Thirty-six healthy postmenopausal women aged between 45 and 55 years will receive 0,625 mg/day conjugated equine estrogen (CEE) for 12 weeks. These 1 active pill containing conjugated equine estrogen, 0,625 mg will be provided by a laboratory with no trademark identification.

The bottles will be numbered in code by a pharmaceutist not involved directly in study and they will donated to volunteers.

During the intervening period, use of conjugated equine estrogen, there will be blinding. After this phase, blinding will be interrupted in order to identify volunteers who used the active drug.

薬：Conjugated Equine Estrogen

Use of conjugated equine estrogen for 12 weeks. Adherence will be monitored during periodical hospital visits in order to receive pills.

他の名前：

Drug active

プラセボコンパレーター：Placebo

Thirty-six healthy postmenopausal women aged between 45 and 55 years will receive placebo pills, identical in size, shape and color to the active drug, via oral administration, for 12 weeks.

The bottles, without trademark identification, will be numbered in code by a pharmaceutist not involved directly in study and they will donated to volunteers.

During the intervening period, use of placebo, there will be blinding. After this phase, blinding will be interrupted in order to identify volunteers who used the active drug and placebo.

薬：Placebo

Use of placebo for 12 weeks. Adherence will be monitored during periodical hospital visits in order to receive pills.

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Arthralgia 時間枠：6 months	Arthralgia´ll be measured by numeric scale (0-10).	6 months

二次結果の測定

結果測定	メジャーの説明	時間枠
Climacteric symptoms 時間枠：6 months	Climacteric symptoms´ll be evaluated by Menopause Rating Scale - Brazilian Version. The score increases point by point with increasing severity of subjectively perceived symptoms in each of the 11 items.	6 months
Level of physical activity 時間枠：6 months	Level of physical activity´ll be evaluated by International Physical Activity Questionnaire - Brazilian Version whose three levels of physical activity are low, moderate and high.	6 months
Pain Catastrophizing 時間枠：6 months	Pain Catastrophizing´ll be evaluated by Pain Catastrophizing - Brazilian Version into three subscales being magnification, rumination, and helplessness. The higher the score, the more catastrophizing thoughts are present.	6 months
Health-related quality of life 時間枠：6 months	Quality of life´ll be evaluated by Women´s Health Questionnaire - Brazilian Version (somatic symptoms, depressed mood, cognitive difficulties, anxiety and fear, sexual functioning, vasomotor symptoms, sleep problems, menstrual problems, and self-perceived attraction). The higher the score, the more pronounced the suffering and dysfunction.	6 months
Depression 時間枠：6 months	Depression´ll be evaluated by Beck Depression Inventory - Brazilian Version. The standard cut-off scores are minimal, mild, moderate and severe depression.	6 months
Anxiety 時間枠：6 months	Anxiety´ll be evaluated by Beck Anxiety Inventory - Brazilian Version. The standard cut-off scores are minimal, mild, moderate and severe depression.	6 months
Quality of sleep 時間枠：6 months	Quality of sleep´ll be evaluated by Pittsburgh Sleep Quality Index - Brazilian Version. Lower scores denote a healthier sleep quality.	6 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Hospital de Clinicas de Porto Alegre

捜査官

主任研究者：Maria Celeste Osório Wender, Ph.D、Hospital de Clinicas de Porto Alegre

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2017年3月1日

一次修了 (予想される)

2019年12月2日

研究の完了 (予想される)

2020年12月31日

試験登録日

最初に提出

2016年6月9日

QC基準を満たした最初の提出物

2016年7月15日

最初の投稿 (見積もり)

2016年7月20日

学習記録の更新

投稿された最後の更新 (実際)

2019年10月14日

QC基準を満たした最後の更新が送信されました

2019年10月11日

最終確認日

2019年1月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

16-0235

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women