Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women
11 oktober 2019 uppdaterad av: 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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
72
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brasilien
- Rekrytering
- Comitê de Ética em Pesquisa do Hospital de Clínicas de Porto Alegre
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Kontakt:
- Maria Celeste Osório Wender, Ph.D
- Telefonnummer: +55513359-8117
- E-post: mceleste@ufrgs.br
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Kontakt:
- Fernanda Vargas Ferreira, Ph.D
- Telefonnummer: +55513359-8117
- E-post: fernandaferreira@unipampa.edu.br
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
45 år till 55 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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. |
Use of conjugated equine estrogen for 12 weeks.
Adherence will be monitored during periodical hospital visits in order to receive pills.
Andra namn:
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Placebo-jämförare: 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. |
Use of placebo for 12 weeks.
Adherence will be monitored during periodical hospital visits in order to receive pills.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Arthralgia
Tidsram: 6 months
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Arthralgia´ll be measured by numeric scale (0-10).
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6 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Climacteric symptoms
Tidsram: 6 months
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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.
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6 months
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Level of physical activity
Tidsram: 6 months
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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.
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6 months
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Pain Catastrophizing
Tidsram: 6 months
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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.
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6 months
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Health-related quality of life
Tidsram: 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.
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6 months
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Depression
Tidsram: 6 months
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Depression´ll be evaluated by Beck Depression Inventory - Brazilian Version.
The standard cut-off scores are minimal, mild, moderate and severe depression.
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6 months
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Anxiety
Tidsram: 6 months
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Anxiety´ll be evaluated by Beck Anxiety Inventory - Brazilian Version.
The standard cut-off scores are minimal, mild, moderate and severe depression.
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6 months
|
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Quality of sleep
Tidsram: 6 months
|
Quality of sleep´ll be evaluated by Pittsburgh Sleep Quality Index - Brazilian Version.
Lower scores denote a healthier sleep quality.
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6 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Maria Celeste Osório Wender, Ph.D, Hospital de Clínicas de Porto Alegre
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 mars 2017
Primärt slutförande (Förväntat)
2 december 2019
Avslutad studie (Förväntat)
31 december 2020
Studieregistreringsdatum
Först inskickad
9 juni 2016
Först inskickad som uppfyllde QC-kriterierna
15 juli 2016
Första postat (Uppskatta)
20 juli 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 oktober 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 oktober 2019
Senast verifierad
1 januari 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 16-0235
Plan för individuella deltagardata (IPD)
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Kliniska prövningar på Conjugated Equine Estrogen
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Julio RamirezUniversity of LouisvilleAvslutadOsteomyelitFörenta staterna