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Can Hormome replacement therapy of menopause improve sleep and quality of life in menopausal women with Fibromyalgia?

Influence of the hormone therapy on sleep and quality of life of menopausal women with fibromyalgia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-24bbzs
Enrollment
Unknown
Registered
2018-12-01
Start date
2018-08-28
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia, Menopause, Sleep-Wake disorders

Interventions

60 women will use transdermal estradiol gel, 0,06%, two pumps daily, for 90 days. Women who have an intact uterus must take micronized progesterone soft capsule, 100mg, oral, daily, for 90 days
Drug

Sponsors

Hospital de Clínicas da Universidade Federal do Paraná
Lead Sponsor
Sociedade Evangélica Beneficente de Curitiba
Collaborator

Eligibility

Sex/Gender
Female
Age
40 Years to 60 Years

Inclusion criteria

Inclusion criteria: Menopausal women with fibromyalgia; with 40 to 60 years old,; and presenting climacteric symptoms

Exclusion criteria

Exclusion criteria: There will exclude from the study the women who won't be able to comprehend and reply the questionnaires due to their limited cognition or idiomatic; the ones who have presented another associated autoimmune rheumatic disease (systemic lupus erythematosus, rheumatoid arthritis); the patients who have absolute contraindication to the hormone replacement therapy ( breast cancer, endometrium cancer, acute an prior thromboembolism, acute or/ and severe liver disease, acute heart disease and uterine bleeding no diagnosed)

Design outcomes

Primary

MeasureTime frame
Effects of the hormone therapy on the impact of Fibromyalgia, evaluated by FIQ-R (Fibromyalgia Impact Questionnaire-Revised), questionnaire validated for use in Brazil.

Secondary

MeasureTime frame
Effects of the hormone therapy on quality of life and sleep evaluated by scores of UQOL ( Utian Quality of life questionnaire); PSQI (Pittsburg Sleep Quality Index), all validated for use in Brazil.

Countries

Brazil

Contacts

Public ContactRejane Dias

Hospital de Clínicas da Universidade Federal do Paraná

rejanecadias@gmail.com55(41) 985249405

Outcome results

None listed

Source: REBEC (via WHO ICTRP)