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Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women

11 oktober 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Onbekend

Conditie

Artralgie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

Fase

Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Brazilië
- Rio Grande Do Sul
  - Porto Alegre, Rio Grande Do Sul, Brazilië
    - Werving
    - Comitê de Ética em Pesquisa do Hospital de Clínicas de Porto Alegre
    - Contact:
      
      Maria Celeste Osório Wender, Ph.D
      
      Telefoonnummer: +55513359-8117
      
      E-mail: mceleste@ufrgs.br
    - Contact:
      
      Fernanda Vargas Ferreira, Ph.D
      
      Telefoonnummer: +55513359-8117
      
      E-mail: fernandaferreira@unipampa.edu.br

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

45 jaar tot 55 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling
Toewijzing: Gerandomiseerd
Interventioneel model: Parallelle opdracht
Masker: Dubbele

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm	Interventie / Behandeling
Experimenteel: 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.	Geneesmiddel: Conjugated Equine Estrogen Use of conjugated equine estrogen for 12 weeks. Adherence will be monitored during periodical hospital visits in order to receive pills. Andere namen: Drug active
Placebo-vergelijker: 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.	Geneesmiddel: Placebo Use of placebo for 12 weeks. Adherence will be monitored during periodical hospital visits in order to receive pills.

Deelnemersgroep / Arm

Interventie / Behandeling

Experimenteel: 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.

Geneesmiddel: Conjugated Equine Estrogen

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

Andere namen:

Drug active

Placebo-vergelijker: 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.

Geneesmiddel: Placebo

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Arthralgia Tijdsspanne: 6 months	Arthralgia´ll be measured by numeric scale (0-10).	6 months

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Climacteric symptoms Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 6 months	Quality of sleep´ll be evaluated by Pittsburgh Sleep Quality Index - Brazilian Version. Lower scores denote a healthier sleep quality.	6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hospital de Clinicas de Porto Alegre

Onderzoekers

Hoofdonderzoeker: Maria Celeste Osório Wender, Ph.D, Hospital de Clinicas de Porto Alegre

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 maart 2017

Primaire voltooiing (Verwacht)

2 december 2019

Studie voltooiing (Verwacht)

31 december 2020

Studieregistratiedata

Eerst ingediend

9 juni 2016

Eerst ingediend dat voldeed aan de QC-criteria

15 juli 2016

Eerst geplaatst (Schatting)

20 juli 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 oktober 2019

Laatste update ingediend die voldeed aan QC-criteria

11 oktober 2019

Laatst geverifieerd

1 januari 2019

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

16-0235

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women