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Effect of a vaginal gel on menopausal women with breast cancer

Evaluation of the effectiveness of a non-hormonal vaginal moisturizer gel on vaginal and sexual health in postmenopausal women with breast cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5cf7vzj
Enrollment
Unknown
Registered
2024-08-26
Start date
2023-10-05
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

Breast Neoplasms

Interventions

Patients will be randomized, in a pre-established numbering sequence, into two groups: study group, vaginal moisturizing gel (n=50) and control group, vaginal lubricant (n=50). Thus, 50 randomized pat

Sponsors

Faculdade de Medicina de Botucatu - Universidade Estadual Paulista
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina de Botucatu da Universidade Estadual Paulista
Collaborator

Eligibility

Sex/Gender
Female
Age
45 Years to 65 Years

Inclusion criteria

Inclusion criteria: Women; date of last menstruation at least 12 months ago; age between 45 and 65 years old; histological diagnosis of breast cancer; completed cancer treatment; except adjuvant endocrine therapy; stage I, II and III; sexually active; presence of vaginal symptoms of menopausal geniturinary sindrome; ability to understand and consent to your participation in the study

Exclusion criteria

Exclusion criteria: Stage IV and or metastatic disease will be excluded; current radiotherapy or chemotherapy; alcoholic or drug addicts; current use of vaginal moisturizers; use of vaginal estrogen in the previous six months; infection of the lower genital tract; cognitive deficit; illiteracy

Design outcomes

Primary

MeasureTime frame
To evaluate the response to the use of non-hormonal vaginal moisturizing gel on the vaginal and sexual health of postmenopausal women with breast cancer compared to vaginal lubricant

Secondary

MeasureTime frame
To evaluate the response to the use of non-hormonal vaginal moisturizing gel on vaginal health and symptoms of genitourinary syndrome in postmenopausal women with breast cancer compared to vaginal lubricant;To evaluate the response to the use of non-hormonal vaginal moisturizing gel on the sexual function of postmenopausal women with breast cancer compared to vaginal lubricant;To evaluate the response to the use of non-hormonal vaginal moisturizing gel on the vaginal flora and the vaginal maturation index of postmenopausal women with breast cancer compared to vaginal lubricant

Countries

Brazil

Contacts

Public ContactEliana Nahas

Faculdade de Medicina de Botucatu - Universidade Estadual Paulista

eliana.nahas@unesp.br+55-14-991291795

Outcome results

None listed

Source: REBEC (via WHO ICTRP)