- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Phase 2
Kontakte und Standorte
Studienkontakt
- Name: Maria Celeste Osório Wender, Ph.D
- Telefonnummer: 55 51 3359-8117
- E-Mail: mceleste@ufrgs.br
Studieren Sie die Kontaktsicherung
- Name: Fernanda Vargas Ferreira, Ph.D
- Telefonnummer: 55 51 3359-8117
- E-Mail: fernandaferreira@unipampa.edu.br
Studienorte
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brasilien
- Rekrutierung
- 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
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Kontakt:
- Fernanda Vargas Ferreira, Ph.D
- Telefonnummer: +55513359-8117
- E-Mail: fernandaferreira@unipampa.edu.br
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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.
Andere Namen:
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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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Arthralgia
Zeitfenster: 6 months
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Arthralgia´ll be measured by numeric scale (0-10).
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6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Climacteric symptoms
Zeitfenster: 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.
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6 months
|
Level of physical activity
Zeitfenster: 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.
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6 months
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Pain Catastrophizing
Zeitfenster: 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
|
Health-related quality of life
Zeitfenster: 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
Zeitfenster: 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
|
Anxiety
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Maria Celeste Osório Wender, Ph.D, Hospital de Clínicas de Porto Alegre
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 16-0235
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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Klinische Studien zur Conjugated Equine Estrogen
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Julio RamirezUniversity of LouisvilleBeendetOsteomyelitisVereinigte Staaten