Comparison of the Efficacy and Tolerability of Femal Versus Placebo

NCT05762042 | Completed

• 1 other identifier: FEMAL
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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).

Conditions

Breast Cancer; Menopause

Outcome Measures

Primary Outcomes (1)

• efficacy of Femal in reducing the mean score of vasomotor symptoms between baseline (T0) and month 3 (T2).

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

  3 months

Study Arms (2)

Femal

EXPERIMENTAL

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

Other: dietary supplement

Placebo

PLACEBO COMPARATOR

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

Other: dietary supplement

Interventions

dietary supplement OTHER

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.

Femal; Placebo

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• Patients on SSRI or SNRI antidepressant therapy are excluded

Sponsors & Collaborators

• Azienda Ospedaliera Ordine Mauriziano di Torino: lead

Study Sites (2)

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Policlinico Gemelli di Roma

Roma, 00042, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 9, 2023
• Study Start: May 10, 2019
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 9, 2023

Record last verified: 2023-02

Locations

IT (2)