Comparison of the Efficacy and Tolerability of Femal Versus Placebo

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

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).

Inclusion Criteria:

- patients with a history of breast cancer, in spontaneous or iatrogenic menopause or who are premenopausal with ovarian function suppressed by GNRH analogue and experiencing severe vasomotor symptoms (at least 20 hot flushes per week).

Patients who are on tamoxifen or aromatase anti-estrogen or aromatase inhibitor therapy are eligible if started at least 2 months prior to study entry

Exclusion Criteria:

• Patients on SSRI or SNRI antidepressant therapy are excluded