NCT05762042

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Azienda Ospedaliera Ordine Mauriziano di Torino · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Breast Cancer
• Menopause

Interventions

Type	Name	Description
OTHER	dietary supplement	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. The mechanism of action of Femal has not yet been fully clarified: Femal inhibits the absorption of serotonin in a dose-dependent manner and has strong antioxidant properties. The lack of estrogenic effects would make this preparation of particular interest for women with a previous hormone-dependent neoplasia who undergo an early iatrogenic menopause. Femal tablets contain a standardized formulation containing: GC Fem pollen extract 40 mg, PI82 pollen / pistil extract 120 mg, vitamin E 5 mg, amino acids 14 mg per tablet. The dosage is 2 tablets a day orally.

Timeline

• Start date: 2019-05-10
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2023-03-09
• Last updated: 2023-03-09

Locations

2 sites across 1 country: Italy