- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02838576
Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women
Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women: a Randomized, Double-blind Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Maria Celeste Osório Wender, Ph.D
- Telefonnummer: 55 51 3359-8117
- E-mail: mceleste@ufrgs.br
Undersøgelse Kontakt Backup
- Navn: Fernanda Vargas Ferreira, Ph.D
- Telefonnummer: 55 51 3359-8117
- E-mail: fernandaferreira@unipampa.edu.br
Studiesteder
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-
Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brasilien
- Rekruttering
- 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-mail: mceleste@ufrgs.br
-
Kontakt:
- Fernanda Vargas Ferreira, Ph.D
- Telefonnummer: +55513359-8117
- E-mail: fernandaferreira@unipampa.edu.br
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
Andre navne:
|
Placebo komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Arthralgia
Tidsramme: 6 months
|
Arthralgia´ll be measured by numeric scale (0-10).
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Climacteric symptoms
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Depression
Tidsramme: 6 months
|
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
|
Anxiety
Tidsramme: 6 months
|
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
|
Quality of sleep
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Maria Celeste Osório Wender, Ph.D, Hospital de Clinicas de Porto Alegre
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 16-0235
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Conjugated Equine Estrogen
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Julio RamirezUniversity of LouisvilleAfsluttetOsteomyelitisForenede Stater