Comparison of the Efficacy and Tolerability of Femal Versus Placebo

Not Applicable

Completed

• Conditions: Breast Cancer; Menopause
• Interventions: Other: dietary supplement

• Registration Number: NCT05762042
• Lead Sponsor: Azienda Ospedaliera Ordine Mauriziano di Torino

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-10
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-02-27
• Last Update Submitted: 2023-02-27
• Study First Posted: 2023-03-09
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	dietary supplement	Patients in this arm will receive PLACEBO (2 cp/die) for three months long
Femal	dietary supplement	Patients in this arm will receive FEMAL (2 cp/die) for three months long

Primary Outcome Measures

Name	Time	Method
efficacy of Femal in reducing the mean score of vasomotor symptoms between baseline (T0) and month 3 (T2).	3 months	verify efficacy of Femal in reducing the mean score of vasomotor symptoms between baseline (T0) and month 3 (T2).

Trial Locations

Locations (2)

Istituto Europeo di Oncologia; 🇮🇹 Milano, Italy

Policlinico Gemelli di Roma; 🇮🇹 Roma, Italy