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Comparison of the Efficacy and Tolerability of Femal Versus Placebo

Breast Cancer Clinical Trial

Official title:
Comparison of the Efficacy and Tolerability of Femal Versus Placebo in the Treatment of Hot Flashes in Patients With Previous Breast Cancer

Clinical Trial Summary

Femal, a food supplement based on pollen extracts introduced in Europe in 1999, is a non-estrogenic alternative to hormone replacement therapy in women with vasomotor symptoms. Patients with prior breast cancer, spontaneous or iatrogenic menopause or who are premenopausal with ovarian function suppressed by GNRH analogue and experiencing severe vasomotor symptoms (at least 20 hot flashes per week) will be included. Patients who are on tamoxifen or anti-estrogen or aromatase inhibitor therapy are eligible if started at least 2 months prior to study entry. Patients on SSRI or SNRI antidepressant therapy are excluded. Eligible patients will be randomly assigned to either Femal (2 cp/day) or placebo (2 cp/day) for 3 months (double-blind study).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05762042
Study type Interventional
Source Azienda Ospedaliera Ordine Mauriziano di Torino
Contact
Status Completed
Phase N/A
Start date May 10, 2019
Completion date April 1, 2022
View Details
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