Comparison of the Efficacy and Tolerability of Femal Versus Placebo

Azienda Ospedaliera Ordine Mauriziano di Torino

Status: Completed

Conditions: Breast Cancer; Menopause

Treatments: Other: dietary supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT05762042

FEMAL

Details and patient eligibility

About

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).

Enrollment: 34 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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34 participants in 2 patient groups, including a placebo group

Femal

Experimental group

Description:

Patients in this arm will receive FEMAL (2 cp/die) for three months long

Treatment:

Other: dietary supplement

Placebo

Placebo Comparator group

Description:

Patients in this arm will receive PLACEBO (2 cp/die) for three months long

Treatment:

Other: dietary supplement